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DRUGS AND DRUG TRAFFICKING ACTNO. 140 OF 1992

[ASSENTED TO 2 JULY, 1992][DATE OF COMMENCEMENT: 30 APRIL, 1993]

(English text signed by the State President)

This Act has been updated to Government Gazette 28075 dated 30 September, 2005.

as amended by

Justice Laws Rationalisation Act, No. 18 of 1996

[with effect from 1 April, 1997]

International Co-operation in Criminal Matters Act, No. 75 of 1996

[with effect from 1 January, 1998]

Proceeds of Crime Act, No. 76 of 1996

Prevention of Organised Crime Act, No. 121 of 1998

Financial Advisory and Intermediary Services Act, No. 37 of 2002

[with effect from 15 November, 2002, unless otherwise indicated]

Regulation of Interception of Communications and Provision of Communication-related Information Act, No. 70 of 2002

[with effect from 30 September, 2005, unless otherwise indicated]

ACT

To provide for the prohibition of the use or possession of, or the dealing in, drugs and of certain acts relating to the manufacture or supply of certain substances or the acquisition or conversion of the proceeds of certain crimes; for the obligation to report certain information to the police; for the exercise of the powers of entry, search, seizure and detention in specified circumstances; for the recovery of the proceeds of drug trafficking; and for matters connected therewith.

ARRANGEMENT OF SECTIONS

CHAPTER IAPPLICATION OF ACT

1. Definitions 2. Operation of Act with regard to Medicines Act

CHAPTER IIILLEGAL ACTS

3. Manufacture and supply of scheduled substances 4. Use and possession of drugs 5. Dealing in drugs 6. . . . . . . 7. . . . . . .

CHAPTER IIIREPORTING OF INFORMATION, AND INVESTIGATIONS

8. Designated officers 9. Relaxation of restrictions on disclosure of information 10. Obligation to report certain information to police 11. Powers of police officials 12. Interrogation of persons under warrant of apprehension CHAPTER IVOFFENCES, PENALTIES, PRESUMPTIONS AND FORFEITURE

13. Offences relating to scheduled substances and drugs 14. Offences relating to proceeds of defined crime 15. Offences relating to reporting of information 16. Offences relating to powers of police officials 17. Penalties 18. Presumption relating to samples of substances 19. Presumptions relating to health matters 20. Presumption relating to possession of drugs 21. Presumptions relating to dealing in drugs 22. Presumption relating to acquisition of proceeds of defined crime 23. Presumption relating to reporting of information 24. Liability of employers and principals 25. Declarations of forfeiture 26. Interests of third parties 27. Evidence in respect of declarations of forfeiture and certain interests CHAPTER V

28 to 53. inclusive . . . . . . 54 to 62. inclusive . . . . . . 63. Amendment of Schedules 1 and 2 64. Jurisdiction of magistrate’s courts 65. . . . . . . 66. Repeal of laws 67. Saving in respect of pending prosecutions 68. Short title and commencement Schedule 1 Scheduled substances Schedule 2 Schedule 3 Laws repealed (section 66)

CHAPTER IAPPLICATION OF ACT

Repealed Act Act 76 of 1996 has been repealed by s 79 of Act 121 of 1998

1. Definitions.—(1) In this Act, unless the context indicates otherwise—

“convert” . . . . . .

[Definition of “convert” deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

“dangerous dependence-producing substance” means any substance or any plant from which a substance can be manufactured included in Part II of Schedule 2;

“deal in”, in relation to a drug, includes performing any act in connection with the transshipment, importation, cultivation, collection, manufacture, supply, prescription, administration, sale, transmission or exportation of the drug;

“declaration of forfeiture” means a declaration of forfeiture made in terms of section 25 (1);

“defined crime” . . . . . .

[Definition of “defined crime” deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

“dependence-producing substance” means any substance or any plant from which a substance can be manufactured included in Part I of Schedule 2;

“designated officer” means any officer referred to in section 8;

“drug” means any dependence-producing substance, any dangerous dependenceproducing substance or any undesirable dependence-producing substance;

“drug offence”—

(a)

in relation to a drug offence committed in the Republic, means an offence referred to in section 13 ( f );(b)

in relation to a drug offence committed outside the Republic, means any act or omission which, if it had occurred within the Republic, would have constituted an offence referred to in that section;“economic offence” . . . . . .

[Definition of “economic offence” deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

“financial institution” . . . . . .

[Definition of “financial institution” deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

“interest” includes any right;“manufacture”, in relation to a substance, includes the preparing, extraction or producing of the substance;

“medicinal purposes”, in relation to a particular drug, means the treatment or prevention of a disease or for some other definite curative or therapeutic purpose, but does not include the

satisfaction or relief of a habit or of a craving for the particular drug or for any other drug;

“Medicines Act” means the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965);

“Minister” means the Minister of Justice;

“place of entertainment” includes any premises, vehicle, vessel or aircraft, or any part thereof, used for or in connection with any exhibition, show, performance, dance, amusement, game, competition or sport;

“plant” includes any portion of a plant;

“police official” means any member of the Force as defined in section 1 of the Police Act, 1958 (Act No. 7 of 1958);

“possess”, in relation to a drug, includes to keep or to store the drug, or to have it in custody or under control or supervision;

“premises” means land or any building, dwelling, flat, room, shop, office or other structure;

“proceeds” . . . . . .

[Definition of “proceeds” deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

“property” means money or any other movable, immovable, corporeal or incorporeal thing;

“record” includes any information contained in a computer or reproduced by a computer print-out, as the case may be;

“scheduled substance” means any substance included in Part I or II of Schedule 1;

“sell”, in relation to a drug, includes to offer, advertise, possess or expose the drug for sale, to dispose of it, whether for consideration or otherwise, or to exchange it;

“undesirable dependence-producing substance” means any substance or any plant from which a substance can be manufactured included in Part III of Schedule 2.

(2) In this Act—

(a)

except where it is inconsistent with the context or clearly inappropriate, any reference to property shall be construed as a reference also to property which is situate outside the Republic;(b)

any reference to a person practising any health service or cognate profession shall be

construed as a reference to a person practising any health service or cognate profession as defined in the Medicines Act.Wording of Sections def: convert of Act 140 of 1992 prior to amendment by Act 121 of 1998

Wording of Sections def: defined crime of Act 140 of 1992 prior to amendment by Act 121 of 1998

Wording of Sections def: economic offence of Act 140 of 1992 prior to amendment by Act 121 of 1998

Wording of Sections def: financial institution of Act 140 of 1992 prior to amendment by Act 121 of 1998

Repealed Act Act 7 of 1958 has been repealed by s 12 of RP 5 of 1995

Repealed Act Act 7 of 1958 has been repealed by s 12 of RP 5 of 1995

Wording of Sections def: proceeds of Act 140 of 1992 prior to amendment by Act 121 of 1998

2. Operation of Act with regard to Medicines Act.—The provisions of this Act shall apply in addition to, and not in substitution for, the provisions of the Medicines Act or any regulation made thereunder.

CHAPTER IIILLEGAL ACTS

Acts relating to scheduled substances and drugs

3. Manufacture and supply of scheduled substances.—No person shall manufacture any scheduled substance or supply it to any other person, knowing or suspecting that any such scheduled substance is to be used in or for the unlawful manufacture of any drug.

4. Use and possession of drugs.—No person shall use or have in his possession—

(a)

any dependence-producing substance; or(b)

any dangerous dependence-producing substance or any undesirable dependence-producing substance,unless—

(i)he is a patient who has acquired or bought any such substance—(aa)

from a medical practitioner, dentist or practitioner acting in his professional capacity and in accordance with the requirements of the Medicines Act or any regulation made thereunder; or(bb)

from a pharmacist in terms of an oral instruction or a prescription in writing of such medical practitioner, dentist or practitioner,and uses that substance for medicinal purposes under the care or treatment of the said medical practitioner, dentist or practitioner;

(ii)he has acquired or bought any such substance for medicinal purposes—(aa)

from a medical practitioner, veterinarian, dentist or practitioner acting in his professional capacity and in accordance with the requirements of the Medicines Act or any regulation made thereunder;(bb)

from a pharmacist in terms of an oral instruction or a prescription in writing of such medical practitioner, veterinarian, dentist or practitioner; or(cc)

from a veterinary assistant or veterinary nurse in terms of a prescription in writing of such veterinarian,with the intent to administer that substance to a patient or animal under the care or treatment of the said medical practitioner, veterinarian, dentist or practitioner;

(iii)he is the Director-General: Welfare who has acquired or bought any such substance in accordance with the requirements of the Medicines Act or any regulation made thereunder;[Sub-para. (iii) amended by s. 4 of Act No. 18 of 1996.]

Wording of Sections

(iv)he, she or it is a patient, medical practitioner, veterinarian, dentist, practitioner, nurse, midwife, nursing assistant, pharmacist, veterinary assistant, veterinary nurse, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter, or any other person contemplated in the Medicines Act or any regulation made thereunder, who or which has acquired, bought, imported, cultivated, collected or manufactured, or uses or is in possession of, or intends to administer, supply, sell, transmit or export any such substance in accordance with the requirements or conditions of the said Act or regulation, or any permit issued to him, her or it under the said Act or regulation;(v)he is an employee of a pharmacist, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter who has acquired, bought, imported, cultivated, collected or manufactured, or uses or is in possession of, or intends to supply, sell, transmit or export any such substance in the course of his employment and in accordance with the requirements or conditions of the Medicines Act or any regulation made thereunder, or any permit issued to

such pharmacist, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter under the said Act or regulation; or(vi)he has otherwise come into possession of any such substance in a lawful manner.Wording of Sections s 4(b)(iii) of Act 140 of 1992 prior to amendment by Act 18 of 1996

5. Dealing in drugs.—No person shall deal in—

(a)

any dependence-producing substance; or(b)

any dangerous dependence-producing substance or any undesirable dependence-producing substance,unless—

(i)he has acquired or bought any such substance for medicinal purposes—(aa)

from a medical practitioner, veterinarian, dentist or practitioner acting in his professional capacity and in accordance with the requirements of the Medicines Act or any regulation made thereunder;(bb)

from a pharmacist in terms of an oral instruction or a prescription in writing of such medical practitioner, veterinarian, dentist or practitioner; or(cc)

from a veterinary assistant or veterinary nurse in terms of a prescription in writing of such veterinarian,and administers that substance to a patient or animal under the care or treatment of the said medical practitioner, veterinarian, dentist or practitioner;

(ii)he is the Director-General: Welfare who acquires, buys or sells any such substance in accordance with the requirements of the Medicines Act or any regulation made thereunder;[Sub-para. (ii) amended by s. 4 of Act No. 18 of 1996.]

Wording of Sections

(iii)he, she or it is a medical practitioner, veterinarian, dentist, practitioner, nurse, midwife, nursing assistant, pharmacist, veterinary assistant, veterinary nurse, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter, or any other person contemplated in the Medicines Act or any regulation made thereunder, who or which prescribes, administers, acquires, buys, transships, imports, cultivates, collects, manufactures, supplies, sells, transmits or exports any such substance in accordance with the requirements

or conditions of the said Act or regulation, or any permit issued to him, her or it under the said Act or regulation; or(iv)he is an employee of a pharmacist, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter who acquires, buys, transships, imports, cultivates, collects, manufactures, supplies, sells, transmits or exports any such substance in the course of his employment and in accordance with the requirements or conditions of the Medicines Act or any regulation made thereunder, or any permit issued to such pharmacist, manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter under the said Act or regulation.Acts relating to proceeds of defined crime

Wording of Sections s 5(b)(ii) of Act 140 of 1992 prior to amendment by Act 18 of 1996

6. . . . . . .

[S. 6 repealed by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

Wording of Sections s 6 of Act 140 of 1992 prior to amendment by Act 121 of 1998

7. . . . . . .

[S. 7 repealed by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

CHAPTER IIIREPORTING OF INFORMATION, AND INVESTIGATIONS

Reporting of information


8. Designated officers.—For the purposes of this Chapter, every commissioned officer of the South African Police Service assigned to the South African Narcotics Bureau shall be a designated officer.

[S. 8 amended by s. 4 of Act No. 18 of 1996.]

Wording of Sections


9. Relaxation of restrictions on disclosure of information.—(1) Any person may,

notwithstanding anything to the contrary contained in any law which prohibits him or her—

(a)

from disclosing any information relating to the affairs or business of any other person; or(b)

from permitting any person to have access to any registers, records or other documents which have a bearing on the said affairs or business,disclose to any attorneygeneral or designated officer such information as he or she may consider necessary for the prevention or combating, whether in the Republic or elsewhere, of a drug offence.

[Sub-s. (1) substituted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

(2) The provisions of subsection (1) shall not be construed as prohibiting any Minister by whom or any other authority by which, or under the control of whom or which, any law referred to in that subsection is administered, or any board, institution or body established by or under any such law, from making any other arrangement with regard to the furnishing of information or the granting of access contemplated in that subsection, according to which the information or access shall be furnished or granted—

(a)

by, or on the authority or with the approval of, any such Minister, authority, board, institution or body or any person designated by any such Minister, authority, board, institution or body; and(b)

subject to the conditions, if any, determined by any such Minister, authority, board, institution, body or person.Wording of Sections s 9(1) of Act 140 of 1992 prior to amendment by Act 121 of 1998

10. Obligation to report certain information to police—(1) If the owner, occupier or manager of any place of entertainment, or any person in control of any place of entertainment or who has the supervision thereof, has reason to suspect that any person in or on such place of entertainment uses, has in his possession or deals in any drug in contravention of the provisions of this Act, he shall—

(a)

as soon as possible report his suspicion to any police official on duty at that place of entertainment or at the nearest police station, as the case may be; and(b)

at the request of the said police official, furnish that police official with such particulars as he may have available regarding the person in respect of whom the suspicion exists.

(2) . . . . . .

[Sub-s. (2) deleted by s. 79 (b) of Act No. 121 of 1998.]

Wording of Sections

(3) If—

(a)

any stock-broker as defined in section 1 of the Stock Exchanges Control Act, 1985 (Act No. 1 of 1985); or[Para. (a) substituted by s. 45 (2) (b) of Act No. 37 of 2002.]

Wording of Sections

(b)

any financial instrument trader as defined in section 1 of the Financial Markets Control Act, 1989 (Act No. 55 of 1989),[Para. (b) substituted by s. 45 (2) (b) of Act No. 37 of 2002.]

Wording of Sections

has reason to suspect that any property acquired by him from any person in the ordinary course of his business is the proceeds of a defined crime, he shall—

(i)as soon as possible report his suspicion to any designated officer; and(ii)at the request of that designated officer, furnish the said officer with such particulars as he may have available regarding the person from whom that property has been acquired.(4) No obligation as to secrecy and no other restriction on the disclosure of any information as to the affairs or business of a customer or client, whether imposed by any law, the common law or any agreement, shall affect any obligation incurred by virtue of the provisions of subsection (2) or (3).

InvestigationsWording of Sections s 10(2) of Act 140 of 1992 prior to amendment by Act 121 of 1998



Wording of Sections s 10(3)(a) of Act 140 of 1992 prior to amendment by Act 37 of 2002



Wording of Sections s 10(3)(b) of Act 140 of 1992 prior to amendment by Act 37 of 2002

11. Powers of police officials.—(1) A police official may—

(a)

if he has reasonable grounds to suspect that an offence under this Act has been or is about to be committed by means or in respect of any scheduled substance, drug or property, at any time—(i)enter or board and search any premises, vehicle, vessel or aircraft on or in which any such substance, drug or property is suspected to be found;(ii)search any container or other thing in which any such substance, drug or property is suspected to be found;(b)

if he has reasonable grounds to suspect that any person has committed or is about to commit an offence under this Act by means or in respect of any scheduled substance, drug or property, search or cause to be searched any such person or anything in his possession or custody or under his control: Provided that a woman shall be searched by a woman only;(c)

if he has reasonable grounds to suspect that any article which has been or is being transmitted through the post contains any scheduled substance, drug or property by means or in respect of which an offence under this Act has been committed, notwithstanding anything to the contrary in any law contained, intercept or cause to be intercepted either during transit or otherwise any such article, and open and examine it in the presence of any suitable person;(d)

question any person who in his opinion may be capable of furnishing any information as to any offence or alleged offence under this Act;(e)

subject to section 15 of the Regulation of Interception of Communications and Provision of Communication-related Information Act, 2002, require from any person who has in his or her possession or custody or under his or her control any register, record or other document which in the opinion of the police official may have a bearing on any offence or alleged offence under this Act, to deliver to him or her then and there, or to submit to him or her at such time and place as may be determined by the police official, any such register, record or document;[Para. (e) substituted by s. 60 of Act No. 70 of 2002.]

( f )

examine any such register, record or document or make an extract therefrom or a copy thereof, and require from any person an explanation of an entry in any such register, record or document;(g)

seize anything which in his opinion is connected with, or may provide proof of, a contravention of a provision of this Act.(2) A police official may in the exercise of his powers under this section—

(a)

require any vehicle, vessel or aircraft to be stopped; or(b)

request the master, pilot or owner of any vessel or aircraft to sail or to fly any such vessel or aircraft, or to cause it to be sailed or flown, to such harbour or airport as may be indicated by the police official.12. Interrogation of persons under warrant of apprehension.—(1) Whenever it appears to a magistrate from information submitted to him on oath by the attorney-general concerned, or by any public prosecutor authorized thereto in writing by that attorneygeneral, that there are reasonable grounds for believing that any person is withholding any information as to a drug offence, whether the drug offence has been or is likely to be committed in the Republic or elsewhere, from that attorney-general, any such public prosecutor or any police official, as the case may be, he may issue a warrant for the arrest and detention of any such person.

(2) Notwithstanding anything to the contrary in any law contained, any person arrested by virtue of a warrant under subsection (1) shall as soon as possible be taken to the place mentioned in the warrant and detained there, or at such other place as the magistrate may from time to time determine, for interrogation in accordance with the directions, if any, issued by the magistrate from time to time.

(3) Any person arrested and detained under a warrant referred to in subsection (1) shall be detained until the magistrate orders his release when satisfied that the detainee has satisfactorily replied to all questions at the interrogation or that no useful purpose will be served by his further detention: Provided that the attorney-general concerned may at any time direct in writing that the interrogation of any particular detainee be discontinued, whereupon that detainee shall be released without delay.

(4) (a) Any person arrested under a warrant referred to in subsection (1) shall be brought before the magistrate within 48 hours of his arrest and thereafter not less than once every ten days.

(b) The magistrate shall at every appearance of such person before him enquire whether he has satisfactorily replied to all questions at his interrogation and whether it will serve any useful purpose to detain him further.

(c) Such person shall be entitled to be assisted at his appearance by his legal representative.

(5) Any person detained in terms of this section may at any time make representations in writing to the magistrate relating to his detention or release.

(6) No person, other than an official in the service of the State acting in the performance of his official duties—

(a)

shall have access to a person detained in terms of this section, except with the consent of the magistrate and subject to such conditions as he may determine: Provided that the magistrate—(i)shall refuse such permission only if he has reason to believe that access to a person so detained will hamper any investigation by the police;(ii)shall not refuse such permission in respect of a legal representative who visits a person so detained with a view to assisting him as contemplated in subsection (4) (c); or(b)

shall be entitled to any official information relating to or obtained from such detainee.(7) (a) Any person detained in terms of this section shall—

(i)as soon as possible be examined by a distrct surgeon; and(ii)not less than once every five days be visited in private by a district surgeon,and such a district surgeon shall as soon as possible compile a report in respect of each such visit and submit it to the magistrate.

(b) The magistrate may, if he has reason to believe that it will not hamper any investigation by the police, furnish at the request of any particular detainee a copy of any report referred to in paragraph (a) to a person indicated by that detainee.

(8) For the purposes of this section “magistrate” includes an additional magistrate.

CHAPTER IVOFFENCES, PENALTIES, PRESUMPTIONS AND FORFEITUREOffences and penalties

13. Offences relating to scheduled substances and drugs—Any person who—

(a)

places any drug in the possession, or in or on the premises, vehicle, vessel or aircraft, of any other person with intent that the latter person be charged with an offence under this Act;(b)

contravenes a provision of section 3;(c)

contravenes a provision of section 4 (a);(d)

contravenes a provision of section 4 (b);(e)

contravenes a provision of section 5 (a); or( f )

contravenes a provision of section 5 (b),shall be guilty of an offence.

14. Offences relating to proceeds of defined crime.—Any person who—

(a)

contravenes a provision of section 6; or(b)

contravenes a provision of section 7,shall be guilty of an offence.

15. Offences relating to reporting of information.—(1) Any person who fails to comply with a provision of section 10 (1), (2) or (3) shall be guilty of an offence.

(2) No prosecution shall be instituted in respect of an offence referred to in subsection (1) without the written authority of the attorney-general concerned.

16. Offences relating to powers of police officials.—Any person who—

(a)

hinders or obstructs any police official in the exercise of his powers under section 11;(b)

refuses or fails to comply to the best of his ability with any requirement or request made by any police official in the exercise of his powers under section 11;(c)

refuses or fails to answer to the best of his ability any question which any police official in the exercise of his powers under section 11 has put to him; or(d)

wilfully furnishes to any police official information which is false or misleading,shall be guilty of an offence.

17. Penalties.—Any person who is convicted of an offence under this Act shall be liable—

(a)

in the case of an offence referred to in section 16, to a fine, or to imprisonment for a period not exceeding twelve months, or to both such fine and such imprisonment;(b)

in the case of an offence referred to in section 13 (a) or (c), to such fine as the court may deem fit to impose, or to imprisonment for a period not exceeding five years, or to both such fine and such imprisonment;(c)

in the case of an offence referred to in section 13 (e), to such fine as the court may deem fit to impose, or to imprisonmnet for a period not exceeding 10 years, or to both such fine and such imprisonment;(d)

in the case of an offence referred to in section 13 (b) or (d), 14 or 15, to such fine as the court may deem fit to impose, or to imprisonment for a period not exceeding 15 years, or to both such fine and such imprisonment; and(e)

in the case of an offence referred to in section 13 ( f ), to imprisonment for a period not exceeding 25 years, or to both such imprisonment and such fine as the court may deem fit to impose.Presumptions and liability of employers and principals

18. Presumption relating to samples of substances.—If in any prosecution for an offence under this Act it is proved that a sample which was taken from any substance by means or in respect of which the offence allegedly was committed possesses particular properties, it shall be presumed, until the contrary is proved, that any such substance possesses the same properties.

19. Presumptions relating to health matters.—(1) Whenever in any prosecution for an offence referred to in section 13 (c), (d), (e) or ( f ) the question arises—

(a)

whether any person is or was practising a particular health service or cognate profession, it shall be presumed, until the contrary is proved, that such person is or was not practising the particular health service or cognate profession;(b)

whether any person is or was any manufacturer of, or wholesale dealer in, pharmaceutical products, importer or exporter, it shall be presumed, until the contrary is proved, that such person is or was not any such manufacturer, wholesale dealer, importer or exporter;(c)

whether any drug has been acquired or bought in terms of any oral instruction or prescription in writing of a medical practitioner, veterinarian, dentist or practitioner, it shall be presumed, until the contrary is proved, that such drug has not been acquired or bought in terms of any such instruction or prescription.(2) If in the prosecution of any person for an offence referred to in section 13 (e) or ( f ) it is

proved that the accused was found in possession of a quantity of drugs which exceeds the quantity of such drugs which the accused could have acquired or bought for medicinal purposes in terms of a particular oral instruction or a particular prescription in writing of a medical practitioner, veterinarian, dentist or practitioner, it shall be presumed, until the contrary is proved, that the accused dealt in such drugs.

20. Presumption relating to possession of drugs.—If in the prosecution of any person for an offence under this Act it is proved that any drug was found in the immediate vicinity of the accused, it shall be presumed, until the contrary is proved, that the accused was found in possession of such drug.

21. Presumptions relating to dealing in drugs.—(1) If in the prosecution of any person for an offence referred to—

(a)

in section 13 ( f ) it is proved that the accused—(i)was found in possession of dagga exceeding 115 grams;(ii)was found in possession in or on any school grounds or within a distance of 100 metres from the confines of such school grounds of any dangerous dependence-producing substance; or(iii)was found in possession of any undesirable dependence-producing substance, other than dagga,it shall be presumed, until the contrary is proved, that the accused dealt in such dagga or substance;

(b)

in section 13 ( f ) it is proved—(i)that dagga plants of the existence of which plants the accused was aware or could reasonably be expected to have been aware, were found on a particular day on cultivated land; and(ii)that the accused was on the particular day the owner, occupier, manager or person in charge of the said land,it shall be presumed, until the contrary is proved, that the accused dealt in such dagga plants;

(c)

in section 13 (e) or ( f ) it is proved that the accused conveyed any drug, it shall be presumed, until the contrary is proved, that the accused dealt in such drug;[Editorial Note: S. 21 (1) (c) has been declared inconsistent with the interim Constitution and therefore to be of no force and effect to the extent set out in the Constitutional Court Order published under Government Notice No. R.585 in Government Gazette 21266 of 15 June, 2000.]

(d)

in section 13 (e) or ( f ) it is proved—(i)that any drug was found on or in any animal, vehicle, vessel or aircraft; and(ii)that the accused was on or in charge of, or that he accompanied, any such animal, vehicle, vessel or aircraft,it shall be presumed, until the contrary is proved, that the accused dealt in such drug.

(2) For the purposes of subsection (1) (a) (ii)—

“school” means any educational institution, except a university, a college of education or a technikon, where full-time education, including pre-primary education, is provided to pupils;

“school grounds”, in relation to a school, means land, whether it is contiguous or not, buildings or accommodation, sporting or other facilities used for or in connection with the activities of the school.

22. Presumption relating to acquisition of proceeds of defined crime.—If in the prosecution of any person for an offence referred to in section 14 (a) it is proved that the accused was found in possession of any property which was the proceeds of a defined crime, it shall be presumed that the accused knew at the time of the acquisition of such property that it was the proceeds of a defined crime, unless he proves—

(a)

that he acquired that property in good faith; and(b)

that the circumstances under which he acquired that property were not of such a nature that he could reasonably have been expected to have suspected that it was the proceeds of a defined crime.23. Presumption relating to reporting of information.—If in any prosecution for the failure to comply with a provision of subsection (1) of section 10, it is proved—(a)

that the accused was on a particular day the owner, occupier or manager of any place of entertainment to which admission is obtained by virtue of any consideration, whether directly or indirectly, or by virtue of any contribution to any fund or for any purpose or by virtue of membership of any association of persons, or that such place of entertainment was on the particular day under the control or supervision of the accused; and(b)

that on the particular day any other person, while he was in or on such place of entertainment, and in contravention of the provisions of this Act, used or was in possession of, or dealt in, any drug,it shall be presumed that the accused had reason for the suspicion contemplated in that subsection, unless he proves—

(i)that he was not on the particular day aware that any person was using or had in his possession

or was dealing in such drug in or on that place of entertainment; and(ii)that the circumstances under which the proven use or possession of, or dealing in, such drug occurred were not of such a nature that he could reasonably have been expected to have been aware of it or to have suspected that a person was using or had in his possession or was dealing in such drug in or on that place of entertainment; and(iii)if those circumstances were of such a nature that it could reasonably be expected of him to have taken precautions against the use or possession of, or dealing in, such drug in or on that place of entertainment by any person, that such precautions had been taken.24. Liability of employers and principals.—(1) An act or omission of an employee or agent which constitutes an offence under this Act shall be deemed to be the act or omission of his employer or principal, and that employer or principal may be convicted and sentenced in respect of it, unless it appears from the evidence—

(a)

that he did not permit or connive at such act or omission; and(b)

that he took all reasonable steps to prevent an act or omission of the kind in question; and(c)

that an act or omission, whether legal or illegal, of the character of the act or omission charged did not under any condition or in any circumstance fall within the course of the employment or the scope of the authority of the employee or agent concerned.(2) For the purposes of subsection (1) (b) the fact that an employer or principal forbade an act or omission of the kind in question shall not by itself be regarded as sufficient that he took all reasonable steps to prevent such an act or omission.

(3) The provisions of subsection (1) shall not relieve the employee or agent concerned from liability to be convicted and sentenced in respect of the act or omission in question.Forfeiture

25. Declarations of forfeiture.—(1) Whenever any person is convicted of an offence under this Act, the court convicting him shall, in addition to any punishment which that court may impose in respect of the offence, declare—

(a)

any scheduled substance, drug or property—(i)by means of which the offence was committed;(ii)which was used in the commission of the offence; or(iii)which was found in the possession of the convicted person;(b)

any animal, vehicle, vessel, aircraft, container or other article which was used—

(i)for the purpose of or in connection with the commission of the offence; or(ii)for the storage, conveyance, removal or concealment of any scheduled substance, drug or property by means of which the offence was committed or which was used in the commission of the offence;(c)

in the case of an offence referred to in section 13 (e) or ( f ), any immovable property which was used for the purpose of or in connection with the commission of that offence,and which was seized under section 11 (1) (g) or is in the possession or custody or under the control of the convicted person, to be forfeited to the State.

(2) Anything forfeited under subsection (1) shall, if it was seized under section 11 (1) (g), be kept or, if it is in the possession or custody or under the control of the convicted person, be seized and kept—

(a)

for a period of 30 days from the date of the declaration of forfeiture; or(b)

if any person referred to in section 26 (1) has within the period contemplated in paragraph (a) made an application to the court concerned regarding his interest in such thing, until a final decision has been rendered in respect of any such application.26. Interests of third parties.—(1) A declaration of forfeiture shall not affect any interest which any person other than the convicted person may have in the property, animal, vehicle, vessel, aircraft, container, article or immovable property in question, if he proves—

(a)

in the case of any property referred to in paragraph (a) of section 25 (1)—(i)that he acquired the interest in that property in good faith and for consideration, whether in cash or otherwise; and(ii)that the circumstances under which he acquired the interest in that property were not of such a nature that he could reasonably have been expected to have suspected that it was the proceeds of a defined crime; (b)

in the case of any animal, vehicle, vessel, aircraft, container, article or immovable property referred to in paragraph (b) or (c) of section 25 (1)—(i)that he did not know that the animal, vehicle, vessel, aircraft, container or article in question was used or would be used as contemplated in the said paragraph (b), or that the immovable property in question was used or would be used as contemplated in the said paragraph (c), as the case may be; or(ii)that he could not prevent such use.

(2) (a) Subject to the provisions of subsection (1), the court concerned or, if the judge or judicial officer concerned is not available, any judge or judicial officer of that court may at any time within a period of three years from the date of the declaration of forfeiture, on the application of any person other than the convicted person who claims that he has any interest in the property, animal, vehicle, vessel, aircraft, container, article or immovable property in question, inquire into and determine any such interest.

(b) If a court referred to in paragraph (a) finds—

(i)that the property, animal, vehicle, vessel, aircraft, container, article or immovable property is wholly owned by the applicant, the court shall set aside the declaration of forfeiture in question and direct that the property, animal, vehicle, vessel, aircraft, container, article or immovable property, as the case may be, be returned to the applicant or, if the State has disposed of it, direct that the applicant be compensated by the State to the extent to which the State has been enriched by the disposal;(ii)that the applicant has an interest in the property, animal, vehicle, vessel, aircraft, container, article or immovable property—(aa)

the court shall direct that the property, animal, vehicle, vessel, aircraft, container, article or immovable property, as the case may be, be sold by public auction and that the applicant be paid out of the proceeds of the sale an amount equal to the value of his interest therein, but not exceeding the proceeds of the sale; or(bb)

if the State has disposed of the property, animal, vehicle, vessel, aircraft, container, article or immovable property in question, the court shall direct that the applicant be compensated by the State in an amount equal to the value of his interest therein, but not exceeding the enrichment of the State by the disposal.(3) Any person aggrieved by a determination made by the court under subsection (2), may appeal against the determination as if it were a conviction by the court making the determination, and such appeal may be heard either separately or jointly with an appeal against the conviction as a result of which the declaration of forfeiture was made, or against a sentence imposed as a result of such conviction.

27. Evidence in respect of declarations of forfeiture and certain interests.—In order to make a declaration of forfeiture or to determine any interest under section 26 (2), the court may refer to the evidence and proceedings at the trial or hear such further evidence, either orally or by affidavit, as it may deem fit.

CHAPTER V

28 to 53 inclusive. . . . . . .

[Chapter V repealed by s. 37 of Act No. 76 of 1996.]

Wording of Sections

CHAPTER VI



Wording of Sections Ch V of Act 140 of 1992 prior to amendment by Act 76 of 1996

54 to 62 inclusive. . . . . . .

[Chapter VI repealed by s. 36 of Act No. 75 of 1996.]

Wording of Sections

CHAPTER VIIGENERAL PROVISIONS

Wording of Sections Ch VI of Act 140 of 1992 prior to amendment by Act 75 of 1996

63. Amendment of Schedules 1 and 2.—The Minister may by notice in the Gazette and after consultation with the Minister of National Health—

(a)

include any substance or plant in Schedule 1 or 2;(b)

delete any substance or plant included in that Schedule; or(c)

otherwise amend that Schedule.64. Jurisdiction of magistrate’s courts.—A magistrate’s court shall have jurisdiction—

(a)

to impose any penalty mentioned in section 17, even though that penalty may exceed the punitive jurisdiction of a magistrate’s court; and(b)

. . . . . .[Para. (b) deleted by s. 38 of Act No. 76 of 1996.]

Wording of Sections



Wording of Sections s 64(b) of Act 140 of 1992 prior to amendment by Act 76 of 1996

65. . . . . . .

[S. 65 repealed by s. 36 of Act No. 75 of 1996.]

Wording of Sections


66. Repeal of laws.—The laws mentioned in Schedule 3 are hereby repealed to the extent indicated in the third column thereof.

67. Saving in respect of pending prosecutions.—Nothing in this Act shall affect any prosecution instituted before the commencement of this Act, and any such prosecution shall be continued and concluded as if this Act had not been passed.

68. Short title and commencement.—This Act shall be called the Drugs and Drug Trafficking Act, 1992, and shall come into operation on a date fixed by the State President by proclamation in the Gazette.

Schedule 1[Schedule 1 amended by Government Notice No. R.344 of 13 March 1998 and by Government Notice No. R.521 of 15 June 2001.]

SCHEDULED SUBSTANCES

Substances useful for the manufacture of drugs

PART I

1. The following substances, namely:

N-Acetylanthranilic acid.

Ephedrine.

Ergometrine.

Ergotamine.

Isosafrole.

Lysergic acid.

3,4-Methylenedioxyphenyl-2-propanone.

Norephedrine, including its optical isomers.

1-phenyl-2-propanone.

Piperonal.

Pseudoephedrine.

Safrole.

2. The salts of all substances included in this Part, where the existence of such salts is possible.

PART II


Acetic anhydride.

Acetone.

Anthranilic acid.

Ethyl ether.Hydrochloric acid.

Methyl ethyl ketone.

Potassium permanganate.

Phenylacetic acid.

Piperidine.

Sulphuric acid.

Toluene.

2. The salts of all substances included in this Part, except hydrochloric acid and sulphuric acid, where the existence of such salts is possible.

Schedule 2

[Schedule 2 amended by Government Notice No. R.1765 of 1 November 1996, by Government Notice No. R.760 of 11 June 1999 and by Government Notice No. R.521 of 15 June 2001.]

PART I

Dependence-Producing Substances

1. The following substances, namely—

Amobarbital, cyclobarbital and pentobarbital, except preparations and mixtures containing not more than 30 milligrams per minimum recommended or prescribed dose when intended for continued use in asthma or containing not more than 50 milligrams per minimum recommended or prescribed dose when intended for continued use in epilepsy.

Buprenorphine.

Butalbital.

Cathine ((+)-norpseudoephedrine), except preparations and mixtures containing 50 milligrams or less of cathine per dosage unit.

Chlorphentermine.

Diethylpropion (amfepramone).

Flunitrazepam.

Gluthethimide.

Meptazinol.

Pentazocine.

2. Unless expressly excluded, all substances included in this Part include the following:

(a)

The salts and esters of the specified substances, where the existence of such salts and esters is possible; and(b)

all preparations and mixtures of the specified substances.PART II

Dangerous Dependence-Producing Substances

1. The following substances or plants, namely—

Acetorphine.

Acetyldihydrocodeine, except preparations and mixtures containing not more than 20 milligrams of acetyldihydrocodeine per recommended or prescribed dose.

Acetylmethadol.

Alfentanil.

Allylprodine.

Alphacetylmethadol.

Alphameprodine.

Alphamethadol.

Alphaprodine.

Anileridine.

Benzethidine.

Benzphetamine.

Benzylmorphine.

Betacetylmethadol.

Betameprodine.Betamethadol.

Betaprodine.

Bezitramide.

Butorphanol.

Chlorodyne (Chloroform and Morphine Tincture BP 1980) or any preparation or mixture thereof described as chlorodyne, except preparations and mixtures containing not more than 5,0 per cent of chlorodyne in combination with other active medicinal substances.

Clonitazene.

Coca leaf and any salt, compound, derivative or preparation of coca leaf, and any salt, compound, derivative or preparation thereof that is chemically equivalent or identical to any of these substances, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except decocainized coca leaf and extractions of coca leaf where such extractions contain no cocaine or ecgonine.

Codeine (methylmorphine), except preparations and mixtures containing not more than 20 milligrams of codeine per recommended or prescribed dose.

Codoxime.

Desomorphine.

Dextromoramide.

Dextropropoxyphene, except preparations and mixtures for oral use containing not more than 135 milligrams dextropropoxyphene, calculated as the base, per dosage unit, or with a concentration of not more than 2,5 per cent in undivided preparations.

Diampromide.

Diethylthiambutene.

Difenoxin (or diphenoxylic acid), except mixtures containing, per dosage unit, not more than 0,5 milligrams of difenoxin, calculated as the base, and a quantity of atropine sulphate equal to at least 5,0 per cent of the quantity of difenoxin, calculated as the base, which is present in the mixture.

Dihydrocodeine, except preparations and mixtures containing not more than 20 milligrams of dihydrocodeine per recommended or prescribed dose.

Dihydroetorphine.

Dihydromorphine.Dimenoxadol.

Dimepheptanol.

Dimethylthiambutene.

Dioxaphetylbutyrate.

Diphenoxylate, except preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit.

Dipipanone.

Dronabinol [(-)-transdelta-9-tetrahydrocannabinol].

Drotebanol.

Ecgonine and the esters and derivatives thereof which are convertible to ecgonine and cocaine.

Ethylmethylthiambutene.

Ethylmorphine, except preparations and mixtures containing not more than 20 milligrams of ethylmorphine per recommended or prescribed dose.

Etonitazene.

Etorphine and analogues.

Etoxeridine.

Fenproporex.

Fentanyl.

Furethidine.

Hydrocodone (dihydrocodeinone).

Hydromorphinol (14-hydroxydihydromorphine).

Hydromorphone (dihydromorphinone).

Hydroxypethidine.

Isomethadone.

Ketobemidone.

Levomoramide.Levophenacylmorphan.

Levorphanol.

Mecloqualone.

Mefenorex.

Metazocine.

Methadone.

Methadone-intermediate.

Methorphan, including levomethorphan and racemethorphan, but excluding dextromethorphan.

Methyldesorphine.

Methyldihydromorphine.

Methylphenidate and the derivatives thereof.

Metopon.

Moramide-intermediate.

Morpheridine.

Morphine, except preparations and mixtures of morphine containing not more than 0,2 per cent of morphine, calculated as anhydrous morphine.

Morphine methobromide and other pentavalent nitrogen morphine derivatives.

Morphine-N-oxide and the derivatives thereof.

Myrophine (myristylbenzylmorphine).

Nicocodine.

Nicodicodine.

Nicomorphine.

Noracymethadol.

Norcodeine, except preparations and mixtures containing not more than 20 milligrams norcodeine per recommended or prescribed dose.

Norlevorphanol.

Normethadone.

Normorphine (demethylmorphine or N-demethylated morphine).

Norpipanone.

Opium and opiates and any salt, compound, derivative or preparation of opium or opiates, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except mixtures containing not more than 0,2 per cent of morphine, calculated as anhydrous morphine.

Opium-poppy and poppy straw, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or whether obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis.

Oxycodone (14-hydroxydihydrocodeinone or dihydrohydroxycodeinone).

Oxymorphone (14-hydroxydihydromophinone or dihydrohydroxymorphinone).

Pethidine, pethidine-intermediate A, pethidine-intermediate B and pethidine-intermediate C.

Phenadoxone.

Phenampromide.

Phenazocine.

Phendimetrazine.

Phenomorphan.

Phenoperidine.

Pholcodine, except preparations and mixtures containing not more than 20 milligrams of pholcodine per recommended or prescribed dose.

Piminodine.

Piritramide.

Proheptazine.

Properidine.

Propiram.

Racemoramide.

Racemorphan.

Remifentanil.

Secobarbital.

Sufentanil.

Thebacon.

Thebaine.

Tilidine.

Trimeperidine.

Zipeprol.

2. Unless expressly excluded, all substances or plants included in this Part include the following:

(a)

The isomers of the specified substances or plants, where the existence of such isomers is possible;

(b)

the esters and ethers of the specified substances or plants and of the isomers referred to in subparagraph (a), as well as the isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible;(c)

the salts of the specified substances or plants, of the isomers referred to in subparagraph (a) and of the esters, ethers and isomers referred to in subparagraph (b), as well as the isomers of such salts, where the existence of such salts and isomers is possible; and(d)

all preparations and mixtures of the specified substances or plants and of the isomers, esters, ethers and salts referred to in this paragraph.PART III

Undesirable Dependence-Producing Substances


Amphetamine.

Brolamfetamine.

4-bromo-2,5-dimethoxyphenethylamine (2C-B), (“Nexus”).

Bufotenine (N,N-dimethylserotonin).

Cannibis (dagga), the whole plant or any portion thereof, except dronabinol [(-)-transdelta-9 tetrahydrocannabinol].

Cathinone.

Dexamphetamine.

Diethyltryptamine [3-(2-(diethylamino)-ethyl)-indole;cb.

2,5-dimethoxyamphetamine (DMA).

2,5-dimethoxy-4-ethylamphetamine (DOET).

(±)-N,μ- dimethyl-3,4-(methylenedioxy) phenethylamine (3,4-methylenedioxymetamfetamine (MDMA).

3-(1,2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo [b, d] pyran-1-ol (DMHP).

Dimethyltryptamine [3-(2-(dimethylamino)-ethyl)-indole].

Etryptamine (3-(2-aminobutyl)indole).

Fenetylline.

Fentanyl-analogues:

acetyl-alpha-methyl-fentanyl;

alpha-methyl-fentanyl;

alpha-methyl-fentanyl-acetanilide;

alpha-methyl-thio-fentanyl;

benzyl-fentanyl;

beta-hydroxy-fentanyl;

beta-hydroxy-3-methyl-fentanyl;

3-methyl-fentanyl and the two isomeric forms thereof, namely,

cis-N-(3-methyl-1-(2-phenethyl)-4-piperidyl)propionanilide and trans-N-(3-methyl-1-(2-phenethyl)-4-piperidyl)propionanilide;

3-methyl-thio-fentanyl;

para-fluoro-fentanyl; and

thiofentanyl.

Gamma-hydroxybutyrate (GHB).

Harmaline (3,4-dihydroharmine).

Harmine [7-methoxy-1-methyl-9H-pyrido (3,4-b)-indole].

Herion (diacetylmorphine).

Levamphetamine.

Levomethamphetamine.

Lysergide (lysergic acid diethylamide).

Mescaline (3,4,5-trimethoxyphenethylamine).

Methamphetamine and methamphetamine racemate.

Methaqualone, including Mandrax, Isonox, Quaalude, or any other preparation containing methaqualone and known by any other trade name.

Methcathinone (2-(methylamino)-1-phenylpropan-1-one).

2-methoxy-4,5-methylenedioxyamphetamine (MMDA).

4-methylaminorex.

4-methyl-2,5-dimethoxyamphetamine (DOM) and the derivatives thereof.

Methylenedioxyamphetamine (MDA):

N-ethyl-methylenedioxyamphetamine; and

N-hydroxy-methylenedioxyamphetamine.

Nabilone.

Parahexyl.

Paramethoxyamphetamine (PMA).Phencyclidine and the congeners thereof, namely, N-ethyl-1-phenylcyclohexylamine (PCE), 1-(1-phenylcyclohexyl) pyrrolidine (PHP or PCPY) and 1- [1-(2-thienyl) cycohexyl] piperidine (TCP).

Pethidine-analogues:

1-methyl-4-phenyl-4-propionoxy-piperidine (MPPP);

1-methyl-4-phenyl-1,2,5,6-tetrahydropiperidine (MPTP); and

1-phenylethyl-4-phenyl-4-acetyloxy-piperidine (PEPAP).

Phenmetrazine.

Psilocin (4-hydroxydimethyltryptamine).

Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine).

Tetrahydrocannabinol.

3,4,5-trimethoxy amphetamine (TMA).


(a)

The isomers of the specified substances or plants, where the existence of such isomers is possible;(b)



all preparations and mixtures of the specified substances or plants and of the isomers, esters, ethers and salts referred to in this paragraph.Schedule 3LAWS REPEALED (SECTION 66)

No. and yearof law Short title Extent of repeal Act No. 41 of 1971 Abuse of Dependence-producing Substances and Rehabilitation Centres Act, 1971 So much as is unrepealed. Act No. 80 of 1973 Abuse of Dependence-producing Substances and Rehabilitation Centres Amendment Act, 1973 So much as is unrepealed. Act No. 14 of 1977 Abuse of Dependence-producing Substances and Rehabilitation Centres Amendment Act, 1977 So much as is unrepealed. Act No. 76 of 1978 Abuse of Dependence-producing Substances and Rehabilitation Centres Amendment Act, 1978 The whole. Act No. 97 of 1986 Transfer of Powers and Duties of the State President Act, 1986 Section 40. Act No. 101 of 1986 Abuse of Dependence-producing Substances and Rehabilitation Centres Amendment Act, 1986 The whole. Act No. 78 of 1990

Abuse of Dependence-producing Substances and Rehabilitation Centres Amendment Act, 1990 The whole.




Repealed Act Act 76 of 1978 has been repealed by s 66 of Act 140 of 1992 Repealed Act Act 101 of 1986 has been repealed by s 66 of Act 140 of 1992


FINANCIAL ADVISORY AND INTERMEDIARYSERVICES ACTNO. 37 OF 2002

[View Regulation]

[ASSENTED TO 15 NOVEMBER, 2002][DATE OF COMMENCEMENT: 15 NOVEMBER, 2002]

(Unless otherwise indicated)

(English text signed by the President)

This Act has been updated to Government Gazette 31561 dated 31 October, 2008.

as amended by

Financial Services Laws General Amendment Act, No. 22 of 2008

[with effect from 1 November, 2008, unless otherwise indicated]

GENERAL NOTE

Kindly note that although the Securities Services Act, No. 36 of 2004 repealed the Financial Markets Control Act, No. 55 of 1989, the Amendment Acts to the latter have not been repealed and in most instances also deal with legislation still in force.

ACT

To regulate the rendering of certain financial advisory and intermediary services to clients; to repeal or amend certain laws; and to provide for matters incidental thereto.

TABLE OF CONTENTS

INTRODUCTORY PROVISIONS

1. Definitions and application

CHAPTER IADMINISTRATION OF ACT

2. Registrar and deputy registrar of financial services providers 3. General provisions concerning registrar 4. Special provisions concerning powers of registrar 5. Advisory Committee on Financial Services Providers 6. Delegations and authorisations

CHAPTER IIAUTHORISATION OF FINANCIAL SERVICES PROVIDERS

7. Authorisation of financial services providers 8. Application for authorisation

9. Suspension and withdrawal of authorisation 10. . . . . . . 11. Lapsing of licence 12. Exemptions in respect of product suppliers

CHAPTER IIIREPRESENTATIVES OF AUTHORISED FINANCIAL SERVICES PROVIDERS 13. Qualifications of representatives and duties of authorised financial services providers 14. Debarment of representatives 14A. Debarment by registrar

CHAPTER IVCODES OF CONDUCT

15. Publication of codes of conduct 16. Principles of codes of conduct

CHAPTER VDUTIES OF AUTHORISED FINANCIAL SERVICES PROVIDERS

17. Compliance officers and compliance arrangements 18. Maintenance of records 19. Accounting and audit requirements

CHAPTER VIENFORCEMENT

Part IOmbud or financial services providers

20. Office of Ombud for Financial Services Providers 21. Appointment of Ombud and deputy ombuds 22. Funding of Office 23. Accountability 24. General administrative powers of Ombud 25. Disestablishment and liquidation of Office 26. Powers of Board 27. Receipt of complaints, prescription, jurisdiction and investigation 28. Determinations by Ombud 29. Record-keeping 30. Report of Ombud 31. Penalties 32. Promotion of client education by registrar

Part II

Other enforcement measures

33. Civil remedies 34. Undesirable practices 35. Regulations 36. Offences and penalties 37. Consideration of quantum of fines and penalties 38. Voluntary sequestration, winding-up and closure 39. Right of appeal

CHAPTER VIIMISCELLANEOUS

40. Saving of rights 41. Fees and penalties 42. Exchange of information 43. . . . . . . 44. Exemptions by registrar and Minister 45. Exemptions, and amendment or repeal of laws 46. Commencement and short title

Schedule Laws amended or repealed

BE IT ENACTED by the Parliament of the Republic of South Africa, as follows:—

INTRODUCTORY PROVISIONS


1. Definitions and application.—(1) In this Act, unless the context indicates otherwise—

“advice” means, subject to subsection (3) (a), any recommendation, guidance or proposal of a financial nature furnished, by any means or medium, to any client or group of clients—

(a)

in respect of the purchase of any financial product; or(b)

in respect of the investment in any financial product; or(c)

on the conclusion of any other transaction, including a loan or cession, aimed at the incurring of any liability or the acquisition of any right or benefit in respect of any financial product; or(d)

on the variation of any term or condition applying to a financial product, on the replacement of any such product, or on the termination of any purchase of or investment in any such product,and irrespective of whether or not such advice—

(i)is furnished in the course of or incidental to financial planning in connection with the affairs of the client; or(ii)results in any such purchase, investment, transaction, variation, replacement or termination, as the case may be, being effected;“Advisory Committee” means the Advisory Committee on Financial Services Providers referred to in section 5;

“application”, in relation to the performance of any act by the registrar, means, except where in a specific case other specific provision is made, an application referred to in section 3 (2);

“auditor” means an auditor registered in terms of the Auditing Profession Act, 2005 (Act No. 26 of 2005);

[Definition of “auditor” substituted by s. 45 (a) of Act No. 22 of 2008.]

Wording of Sections

“authorised financial services provider” or “provider” means a person who has been granted an authorisation as a financial services provider by the issue to that person of a licence under section 8;

“Board” means the Financial Services Board established by section 2 of the Financial Services Board Act;

“board of appeal” means the board of appeal established by section 26 (1) of the Financial Services Board Act;

“client” means a specific person or group of persons, excluding the general public, who is or may become the subject to whom a financial service is rendered intentionally, or is the successor in title of such person or the beneficiary of such service;

“code of conduct” means any published code of conduct contemplated in section 15;

“collective investment scheme” means a collective investment scheme as defined in the Collective Investment Schemes Control Act, 2002;

“complainant” means, subject to section 26 (1) (a) (ii), a specific client who submits a complaint to the Ombud;

“complaint” means, subject to section 26 (1) (a) (iii), a specific complaint relating to a financial service rendered by a financial services provider or representative to the complainant on or after the date of commencement of this Act, and in which complaint it is alleged that the provider or representative—

(a)

has contravened or failed to comply with a provision of this Act and that as a result thereof the complainant has suffered or is likely to suffer financial prejudice or damage;(b)

has wilfully or negligently rendered a financial service to the complainant which has caused prejudice or damage to the complainant or which is likely to result in such prejudice or damage; or(c)

has treated the complainant unfairly;“compliance officer” means a compliance officer for an authorised financial services provider referred to in section 17;

“Court” means any court having jurisdiction;

“document” includes a document created, recorded, transmitted or stored in digital or other intangible but readable form by way of electronic, magnetic, optical or any similar means;

[Definition of “document” inserted by s. 45 (b) of Act No. 22 of 2008.]

“exempt” means to exempt, on application by a person or on the registrar’s own initiative, on any of the grounds mentioned in section 44 (1) (a), (b) or (c) and (4) (a);

“financial product” means, subject to subsection (2)—

(a)

securities and instruments, including—(i)shares in a company other than a “share block company” as defined in the Share Blocks Control Act, 1980 (Act No. 59 of 1980);(ii)debentures and securitised debt;(iii)any money-market instrument;(iv)any warrant, certificate, and other instrument acknowledging, conferring or creating rights to subscribe to, acquire, dispose of, or convert securities and instruments referred to in subparagraphs (i), (ii) and (iii);(v)any “securities” as defined in section 1 of the Securities Services Act, 2002;(b)

a participatory interest in one or more collective investment schemes;(c)

a long-term or a short-term insurance contract or policy, referred to in the Long-term Insurance Act, 1998 (Act No. 52 of 1998), and the Short-term Insurance Act, 1998 (Act No. 53 of 1998), respectively;(d)

a benefit provided by—(i)a pension fund organisation as defined in section 1 (1) of the Pension Funds Act, 1956 (Act No. 24 of 1956), to the members of the organisation by virtue of membership; or(ii)a friendly society referred to in the Friendly Societies Act, 1956 (Act No. 25 of 1956), to the members of the society by virtue of membership;(e)

a foreign currency denominated investment instrument, including a foreign currency deposit;( f )

a deposit as defined in section 1 (1) of the Banks Act, 1990 (Act No. 94 of 1990);(g)

a health service benefit provided by a medical scheme as defined in section 1 (1) of the Medical Schemes Act, 1998 (Act No. 131 of 1998);(h)

any other product similar in nature to any financial product referred to in paragraphs (a) to (g), inclusive, declared by the registrar, after consultation with the Advisory Committee, by notice in the Gazette to be a financial product for the purposes of this Act;(i)

any combined product containing one or more of the financial products referred to in paragraphs (a) to (h), inclusive;( j)

any financial product issued by any foreign product supplier and marketed in the Republic and which in nature and character is essentially similar or corresponding to a financial product referred to in paragraphs (a) to (i), inclusive;“financial service” means any service contemplated in paragraph (a), (b) or (c) of the definition of “financial services provider”, including any category of such services;

“Financial Services Board Act” means the Financial Services Board Act, 1990 (Act No. 97 of 1990);

“financial services provider” means any person, other than a representative, who as a regular feature of the business of such person—

(a)

furnishes advice; or(b)

furnishes advice and renders any intermediary service; or(c)

renders an intermediary service;“intermediary service” means, subject to subsection (3) (b), any act other than the furnishing of advice, performed by a person for or on behalf of a client or product supplier—

(a)

the result of which is that a client may enter into, offers to enter into or enters into any transaction in respect of a financial product with a product supplier; or(b)

with a view to—(i)buying, selling or otherwise dealing in (whether on a discretionary or non-discretionary basis), managing, administering, keeping in safe custody, maintaining or servicing a financial product purchased by a client from a product supplier or in which the client has invested;(ii)collecting or accounting for premiums or other moneys payable by the client to a product supplier in respect of a financial product; or(iii)receiving, submitting or processing the claims of a client against a product supplier;

“key individual”, in relation to an authorised financial services provider, or a representative, carrying on business as—

(a)

a corporate or unincorporated body, a trust or a partnership, means any natural person responsible for managing or overseeing, either alone or together with other so responsible persons, the activities of the body, trust or partnership relating to the rendering of any financial service; or(b)a corporate body or trust consisting of only one natural person as member, director, shareholder or trustee, means any such natural person;“licence” means a licence contemplated in section 7 (1);

“licensee” means a financial services provider to whom a licence has been issued under section 8;

“Minister” means the Minister of Finance;

“Office” means the Office of the Ombud established by section 20 (1);

“Ombud” means—

(a)

the Ombud for Financial Services Providers appointed in terms of section 21 (1); and(b)

for the purposes of sections 27, 28, 31 and 39, includes a deputy ombud;“person” means any natural person, partnership or trust, and includes—

(a)

any organ of state as defined in section 239 of the Constitution of the Republic of South Africa, 1996 (Act No. 108 of 1996);(b)

any company incorporated or registered as such under any law;(c)

any body of persons corporate or unincorporate;“prescribe” means prescribe by regulation;

“product supplier” means any person who issues a financial product by virtue of an authority, approval or right granted to such person under any law, including the Companies Act, 1973 (Act No. 61 of 1973);

“registrar” means the registrar or deputy registrar of financial services providers referred to in section 2;

“regulation” means a regulation made under section 35;

“regulatory authority” means an entity established in terms of national legislation responsible for regulating activities of an industry, or sector of an industry;

[Definition of “regulatory authority” inserted by s. 45 (c) of Act No. 22 of 2008.]

“representative” means any person, including a person employed or mandated by such first-mentioned person, who renders a financial service to a client for or on behalf of a financial services provider, in terms of conditions of employment or any other mandate, but excludes a person rendering clerical, technical, administrative, legal, accounting or other service in a subsidiary or subordinate capacity, which service—

(a)

does not require judgment on the part of the latter person; or(b)

does not lead a client to any specific transaction in respect of a financial product in response to general enquiries;[Definition of “representative” substituted by s. 45 (d) of Act No. 22 of 2008.]

Wording of Sections

“rule” means a rule made by the Board under section 26;

“this Act” includes any regulation, rule or code of conduct, and any notice given, approval or exemption granted, determination made, requirement or condition determined or imposed, or any other decision referred to in section 3 (1).

(2) For the purposes of this Act a financial product does not include any financial product exempted from the provisions of this Act by the registrar, after consultation with the Advisory Committee, by notice in the Gazette, taking into consideration the extent to which the rendering of financial services in respect of the product is regulated by any other law.

(3) For the purposes of this Act—

(a)

advice does not include—(i)factual advice given merely—(aa)

on the procedure for entering into a transaction in respect of any financial product;(bb)

in relation to the description of a financial product;(cc)

in answer to routine administrative queries;(dd)

in the form of objective information about a particular financial product; or(ee)

by the display or distribution of promotional material;(ii)an analysis or report on a financial product without any express or implied recommendation, guidance or proposal that any particular transaction in respect of the product is appropriate to the particular investment objectives, financial situation or particular needs of a client;(iii)advice given by—(aa)

the board of management, or any board member, of any pension fund organisation or friendly society referred to in paragraph (d) of the definition of “financial product” in subsection (1) to the members of the organisation or society on benefits enjoyed or to be enjoyed by such members; or(bb)

the board of trustees of any medical scheme referred to in paragraph (g) of the said definition of “financial product”, or any board member, to the members of the medical scheme, on health care benefits enjoyed or to be enjoyed by such members; or(iv)any other advisory activity exempted from the provisions of this Act by the registrar, after consultation with the Advisory Committee, by notice in the Gazette;(b)

intermediary service does not include—(i)the rendering by a bank, mutual bank or co-operative bank of a service contemplated in paragraph (b) (ii) of the definition of “intermediary service” where the bank, mutual bank or co-operative bank acts merely as a conduit between a client and another product supplier;[Sub-para. (i) substituted by s. 45 (e) of Act No. 22 of 2008.]

Wording of Sections

(ii)an intermediary service rendered by a product supplier—(aa)

who is authorised under a particular law to conduct business as a financial institution; and(bb)

where the rendering of such service is regulated by or under such law;(iii)any other service exempted from the provisions of this Act by the registrar, after consultation with the Advisory Committee, by notice in the Gazette.(4) The provisions of this Act only apply to the rendering of a financial service in respect of

a deposit referred to in paragraph ( f ) of the definition of “financial product” in subsection (1) with a term not exceeding 12 months by a provider which is a bank as defined in the Banks Act, 1990 (Act No. 94 of 1990), or a mutual bank as defined in the Mutual Banks Act, 1993 (Act No. 124 of 1993), or a co-operative bank as defined in the Co-operative Banks Act, 2007 (Act No. 40 of 2007), to the extent that such application is regulated in the code of conduct contemplated in section 15 (2) (b).

[Sub-s. (4) substituted by s. 45 ( f ) of Act No. 22 of 2008.]

Wording of Sections

(5) Provisions of this Act relating to financial services providers, representatives and product suppliers apply to any natural person or group of natural persons acting within the scope of their official duties in the employ of the State, or any organisational unit of the State, or any public entity, unless the Minister by notice in the Gazette determines otherwise in respect of any such person, group, unit or entity.

(6) This Act must be construed as being in addition to any other law not inconsistent with its provisions and not as replacing any such law.

CHAPTER IADMINISTRATION OF ACT

Wording of Sections def: auditor of Act 37 of 2002 prior to amendment by Act 22 of 2008

Wording of Sections def: representative of Act 37 of 2002 prior to amendment by Act 22 of 2008

Wording of Sections s 1(3)(b)(i) of Act 37 of 2002 prior to amendment by Act 22 of 2008

Wording of Sections s 1(4) of Act 37 of 2002 prior to amendment by Act 22 of 2008

2. Registrar and deputy registrar of financial services providers.—The executive officer and deputy executive officer of the Board are respectively the registrar and deputy registrar of financial services providers and have the powers and duties provided for by or under this Act or any other law.

3. General provisions concerning registrar.—(1) Subject to the provisions of this Act, any notice given, approval or exemption granted, determination made, requirement or condition determined or imposed, or any other decision taken by the registrar under an enabling provision of this Act, is valid only if it is reduced to a durable written or printed form or, where communicated electronically, has been correctly transmitted in a legible form.

(2) Whenever the performance of any act contemplated in subsection (1) is sought by a person under this Act or any other law, application therefor must, subject to any other specific provision of this Act, be made in writing to the registrar and the application must—

(a)

be made in the form and manner determined by or in terms of this Act, or any other law, or as otherwise required by the registrar;(b)

be accompanied by—(i)the fees payable in terms of this Act; and(ii)the information or documents required by the registrar.(3) The registrar must in connection with the application of any provision of this Act to or in respect of any financial product or financial service, consult with any regulatory or supervisory authority in the Republic, including the Registrar of Medical Schemes, referred to in section 42, who is by law empowered to perform a regulatory or supervisory function in respect of such product or service.

4. Special provisions concerning powers of registrar.—(1) When anything is required or permitted to be done by the registrar in terms of this Act within a particular period, the registrar may on application or on own initiative before the expiry of that period, extend it for any sufficient cause.

(2) The registrar may by notice direct an authorised financial services provider or representative to furnish the registrar, within a specified period, with specified information or documents required by the registrar for the purposes of this Act.

(3) (a) If any advertisement, brochure or similar document relating to the rendering of a financial service by an authorised financial services provider or a representative is being, or is to be, published by any person, and any such document is misleading, or confusing, or contains any incorrect statement of fact, the registrar may by notice direct that person not to publish it, to cease publishing it or to effect changes thereto.

(b) A notice contemplated in paragraph (a) takes effect on a date specified in such notice after the registrar has—

(i)provided the person concerned with the reasons for the notice; and(ii)afforded the person concerned a reasonable opportunity to be heard.(4) If there is reason to believe that a person is contravening or failing to comply with, or has contravened or failed to comply with, a provision of this Act, the registrar may—

(a)

by notice direct that person—(i)to furnish the registrar within a specified period with any specified information or documents in the possession or under the control of that person and which relate to the subject-matter of such contravention or failure;(ii)

to appear before the registrar at a specified time and place for the purpose of discussing such matter with the registrar; or(iii)to make arrangements for the discharge of all or any part of that person’s obligations in terms of this Act;(b)

if satisfied that in the case concerned significant prejudice or damage to clients has occurred or may occur, apply to a Court for an order restraining such person from continuing business or dealing with the funds or other property held by such person on behalf of clients or other persons, pending the institution by the registrar of an application or action contemplated in section 33 (1) and (2), or the exercising by the registrar of such other legal remedy as may be available to the registrar;(c)

if prejudice or damage may have occurred to a client, refer the matter, together with any information or documentation in the registrar’s possession, to the Office to be dealt with as a complaint by the client concerned.(5) (a) The registrar may—

(i)authorise any suitable person in the employ of the Board or any other suitable person to conduct an on-site visit of the business and affairs of a provider or representative, to determine compliance with this Act; or(ii)instruct an inspector under section 3 of the Inspection of Financial Institutions Act, 1998 (Act No. 80 of 1998).(b) A person conducting an on-site visit in terms of paragraph (a) (i) may—

(i)at any time during business hours—(aa)

enter the premises of the provider or representative and the provider or representative must upon request provide any document;(bb)

search the premises of the provider or representative for any document;(cc)

examine, make extracts from and copy any document or, against the issue of a receipt, temporarily remove the document;(dd)

seize any document against the issue of a receipt, which may furnish proof of any failure to comply with the provisions of this Act;(ii)require the provider or representative to produce at a specified time and place any specified documents or documents of a specified description in the possession or under the control of the provider or representative;

(iii)require any person that is holding or is accountable for any document to provide information and an explanation of that information.[Sub-s. (5) added by s. 46 of Act No. 22 of 2008.](6) After an on-site visit or inspection has been carried out in terms of subsection (5), the registrar may direct the provider, representative or person concerned to take any steps, or to refrain from performing or continuing to perform any act, to terminate or remedy any contravention of or failure to comply with any provision of this Act.

[Sub-s. (6) added by s. 46 of Act No. 22 of 2008.]

(7) The registrar may make known—

(a)

the status and outcome of an inspection;(b)

the details of an inspection if disclosure is in the public interest;(c)

the outcome and details of an on-site visit if disclosure is in the public interest, by notice in the Gazette or by means of any other appropriate public media.[Sub-s. (7) added by s. 46 of Act No. 22 of 2008.]

5. Advisory Committee on Financial Services Providers.—(1) There is an Advisory Committee on Financial Services Providers which may on its own initiative, or must at the request of the Minister or the registrar, investigate and report or advise on any matter relating to financial services providers.

(2) The Advisory Committee consists of a chairperson and other members, including a representative of the Council for Medical Schemes established by section 3 of the Medical Schemes Act, 1998 (Act No. 131 of 1998), and persons representative of product suppliers, financial services providers and clients involved in the application of this Act, appointed by the Minister after consultation with the Board.

(3) The registrar is a member of the Advisory Committee by virtue of the office of the registrar, but without voting power on matters on which the registrar is to be advised by the Committee.

(4) A member of the Advisory Committee, excluding the registrar, holds office for the period determined by the Minister when the appointment is made.

(5) A member of the Advisory Committee, excluding the registrar, who is not in the full-time employment of the State or the Board must be paid such remuneration and allowances in respect of any expenses incurred in the performance of the functions of that committee, as may be determined by the Board.

(6) The Advisory Committee may meet or otherwise arrange for the performance of its functions, and may regulate its meetings as it thinks fit, after consultation with the Board.

(7) The registrar may submit to the Advisory Committee any information which is in the registrar’s possession, and which is relevant to any matter which the Committee is investigating or considering.

(8) The Advisory Committee may call to its assistance such person or persons as it may deem necessary to assist it, or to investigate matters relating to financial services providers.

(9) The registrar is responsible for the administrative work incidental to the performance of the functions of the Advisory Committee.

(10) The expenditure connected with the functions of the Advisory Committee must be paid out of the funds of the Board, whose approval is required for all expenditure proposed to be incurred, or actually incurred, by the Committee.

(11) For the purposes of any investigation by the Advisory Committee, the provisions of the Commissions Act, 1947 (Act No. 8 of 1947), regarding the summoning and examination of persons and the administering of oaths or affirmations to them, the calling for the production of books, documents and objects, and offences by witnesses, apply with the necessary changes.

6. Delegations and authorisations.—(1) The Minister may, on such conditions as the Minister may determine (which the Minister may at any time thereafter amend or withdraw), delegate any power conferred upon the Minister by this Act, excluding the power to make regulations under section 35, to the head of the National Treasury, any other official in the National Treasury, or the registrar.

(2) The Board may—

(a)

on such conditions as the Board may determine (which the Board may at any time thereafter amend or withdraw), delegate to the chairperson, any other member of the Board or the registrar, any power conferred on the Board by or under this Act, excluding the power to make rules under section 26; or(b)

so authorise the chairperson, any other member of the Board or the registrar, to carry out any duty assigned to the Board by or under this Act.(3) The registrar may—

(a)

on such conditions as the registrar may determine (which the registrar may at any time thereafter amend or withdraw), delegate to—(i)another member of the executive of the Board;(ii)any person who has been appointed by the Board; or(iii)

any person or body recognised by the Board for that purpose, any power conferred upon the registrar by or under this Act, including a power delegated to the registrar under this Act; or(b)so authorise such member of the executive, person or body to carry out any duty assigned to the registrar by or under this Act.(4) For the purposes of recognition by the Board of a body contemplated in subsection (3) (a) (iii), the following provisions apply:

(a)

Any body of persons which represents a group of persons falling within the ambit of this Act, may apply to the registrar for recognition by the Board by notice in the Gazette as a representative body for the purpose of performing the functions determined by the registrar, after consultation with the Advisory Committee and the Board;[General Note: Functions to be performed by recognised representative bodies determined under Board Notice No. 33 in Government Gazette 24794 of 2 May, 2003. Notification of represenative bodies recognised for performing certain functions published under Board Notice No. 132 in Government Gazette 25702 of 7 November, 2003.]

(b)

an application for such recognition—(i)must be made in the manner determined by the registrar by notice in the Gazette;(ii)must be accompanied by the fee determined in terms of this Act;(iii)must be accompanied by information proving that the applicant has sufficient financial, management, and manpower resources and experience necessary for performing the functions determined by the registrar, and that the applicant is reasonably representative of the relevant group of persons which it purports to represent;[General Note: Applications by represenative bodies for recognition by the Financial Services Board determined under Board Notice No. 34 in Government Gazette 24794 of 2 May, 2003.]

(c)

if the registrar is satisfied that the applicant has complied with all requirements, the application must be submitted by the registrar to the Board for consideration;(d)

the Board may—(i)grant an application unconditionally; or(ii)grant an application subject to such conditions as it deems necessary, after having given the applicant a reasonable opportunity to make submissions on the proposed conditions and having considered any such submissions, and direct the registrar to inform the applicant accordingly; or(iii)

after having given the applicant a reasonable opportunity to make submissions and having considered any such submissions, refuse an application and direct the registrar to furnish the applicant with the written reasons of the Board for the refusal;(e)

a body recognised as a representative body contemplated in this subsection may at any time apply to the Board for the withdrawal or amendment of any condition imposed on the granting of the application;( f )

the Board may—(i)grant any application, or portion thereof, referred to in paragraph (e) and direct the registrar to inform the applicant accordingly; or(ii)refuse any such application, or portion thereof, and direct the registrar to furnish the applicant with the written reasons of the Board for the refusal.(5) Any delegation or authorisation contemplated in this section does not prohibit the exercise of the power concerned or the carrying out of the duty concerned by the Minister, Board or registrar, as the case may be.

(6) Anything done or omitted to be done under any delegation or authorisation contemplated in this section is deemed to have been done or omitted by the Minister, the Board or the registrar, as the case may be.

CHAPTER IIAUTHORISATION OF FINANCIAL SERVICES PROVIDERS

7. Authorisation of financial services providers.—(1) With effect from a date determined by the Minister by notice in the Gazette, a person may not act or offer to act as a financial services provider unless such person has been issued with a licence under section 8.

(General Note: Date determined as 30 September, 2004 under Government Notice No. 270 in Government Gazette 26080 of 5 March, 2004.)

(2) Subject to section 40, a transaction concluded on or after the date contemplated in subsection (1) between a product supplier and any client by virtue of any financial service rendered to the client by a person not authorised as a financial services provider, or by any other person acting on behalf of such unauthorised person, is not unenforceable between the product supplier and the client merely by reason of such lack of authorisation.

(3) An authorised financial services provider or representative may only conduct financial services related business with a person rendering financial services if that person has, where lawfully required, been issued with a licence for the rendering of such financial services and the conditions and restrictions of that licence authorises the rendering of those financial services, or is a representative as contemplated in this Act.

[Sub-s. (3) added by s. 47 of Act No. 22 of 2008 with effect from 1 May, 2009.)

8. Application for authorisation.—(1) An application for an authorisation referred to in

section 7 (1), including an application by an applicant not domiciled in the Republic, must be submitted to the registrar in the form and manner determined by the registrar by notice in the Gazette, and be accompanied by information to satisfy the registrar that the applicant complies with the requirements for fit and proper financial services providers or categories of providers, determined by the registrar by notice in the Gazette, after consultation with the Advisory Committee, in respect of—

(a)

personal character qualities of honesty and integrity;(b)

the competence and operational ability of the applicant to fulfil the responsibilities imposed by this Act; and(c)

the applicant’s financial soundness:Provided that where the applicant is a partnership, a trust or a corporate or unincorporated body, the applicant must, in addition, so satisfy the registrar that any key individual in respect of the applicant complies with the said requirements in respect of—

(i)personal character qualities of honesty and integrity; and(ii)competence and operational ability, to the extent required in order for such key individual to fulfil the responsibilities imposed on the key individual by this Act.

[General Note: Fit and proper requirements for financial services providers determined under Board Notice No. 91 in Government Gazette 25446 of 10 September, 2003.]

(2) The registrar may—

(a)

require an applicant to furnish such additional information, or require such information to be verified, as the registrar may deem necessary; and(b)

take into consideration any other information regarding the applicant, derived from whatever source, including the Ombud and any other regulatory or supervisory authority, if such information is disclosed to the applicant and the latter is given a reasonable opportunity to respond thereto.(3) The registrar must after consideration of an application—

(a)

if satisfied that an applicant complies with the requirements of this Act, grant the application; or(b)

if not so satisfied, refuse the application.(4) (a) Where an application is granted, the registrar may impose such conditions and restrictions on the exercise of the authority granted by the licence, and to be included in the licence, as are necessary, having regard to—

(i)all facts and information available to the registrar pertaining to the applicant and any key individual of the applicant;(ii)the category of financial services which the applicant could appropriately render or wishes to render;(iii)the category of financial services providers in which the applicant will be classified in relation to the fit and proper requirements mentioned in subsection (1); and(iv)any guidelines provided to the registrar by the Advisory Committee or the Board.(b) Conditions and restrictions contemplated in paragraph (a), may include a condition that where after the date of granting of the licence—

(i)any key individual in respect of the licensee’s business is replaced by a new key individual; or(ii)any new key individual is appointed or assumes office; or(iii)any change occurs in the personal circumstances of a key individual which affects the fit and proper requirements mentioned in subsection (1) and renders or may render such person to be no longer a fit and proper person, no such person may be permitted to take part in the conduct or management or oversight of the licensee’s business in relation to the rendering of financial services, unless such person has on application been approved by the registrar in the manner and in accordance with a procedure determined, after consultation with the Advisory Committee, by the registrar by notice in the Gazette.

[General Note: Determination of procedure for approval of key individuals published under Board Notice No. 122 in Government Gazette 25628 of 24 October, 2003.]

(5) (a) Where an application is granted, the registrar must issue to the applicant—

(i)a licence authorising the applicant to act as a financial services provider, in the form determined by the registrar by notice in the Gazette; and(ii)such number of certified copies of the licence as may be requested by the applicant.(b) The registrar may at any time after the issue of a licence—

(i)on application by the licensee or on own initiative withdraw or amend any condition or restriction in respect of the licence, after having given the licensee a reasonable opportunity

to make submissions on the proposed withdrawal or amendment and having considered those submissions, if the registrar is satisfied that any such withdrawal or amendment is justified and will not prejudice the interests of clients of the licensee; or(ii)pursuant to an evaluation of a new key individual, or a change in the personal circumstances of a key individual, referred to in subsection (4), impose new conditions on the licensee after having given the licensee a reasonable opportunity to be heard and having furnished the licensee with reasons,and must in every such case issue an appropriately amended licence to the licensee, and such number of certified copies of the amended licence as may be requested by the licensee.

(6) Where an application referred to in subsection (1) is refused, the registrar must—

(a)

notify the applicant thereof; and(b)

furnish reasons for the refusal.(7) (a) Despite the provisions of subsections (1), (2) and (3), a person granted accreditation under section 65 (3) of the Medical Schemes Act, 1998 (Act No. 131 of 1998), must, subject to this subsection, be granted authority to render as a financial services provider the specific financial service for which the person was accredited, and must be issued with a licence in terms of subsection (5).

(b) The registrar must be satisfied that a person to be granted authority under paragraph (a), and any key individual of such person, comply with the applicable fit and proper requirements determined under subsection (1).

(c) A person granted authority and licensed as contemplated in paragraph (a), together with any key individual, are thereafter subject to the provisions of this Act.

(d) If a licence—

(i)is refused in terms of this section;(ii)is suspended in terms of section 9;(iii)is withdrawn in terms of section 10; or(iv)lapses in terms of section 11, the accreditation referred to in paragraph (a) is deemed to have lapsed in terms of the Medical Schemes Act, 1998, or to have been suspended or withdrawn, as the case may be.

(e) If an accreditation referred to in paragraph (a) is suspended or withdrawn or lapses in terms of the Medical Schemes Act, 1998, the licence issued in terms of that paragraph is deemed to have been suspended or withdrawn or to have lapsed in terms of sections 9, 10 and 11, respectively, of this Act.

(8) A licensee must—

(a)

display a certified copy of the licence in a prominent and durable manner within every business premises of the licensee;(b)

ensure that a reference to the fact that such a licence is held is contained in all business documentation, advertisements and other promotional material;(c)

ensure that the licence is at all times immediately or within a reasonable time available for production to any person requesting proof of licensed status under authority of a law or for the purpose of entering into a business relationship with the licensee.(9) A person may not in any manner make use of any licence or copy thereof for business purposes where the licence has lapsed or has been withdrawn or, subject to section 9 (2), during any time when the licensee is under provisional or final suspension contemplated in section 9.

(10) (a) Where a provider is a corporate or unincorporated body, a trust or a partnership, the provider must—

(i)at all times be satisfied that every director, member, trustee or partner of the provider, who is not a key individual in the provider’s business, complies with the requirements in respect of personal character qualities of honesty and integrity as contemplated in paragraph (a) of section 8 (1);(ii)within 15 days of the appointment of a new director, member, trustee or partner, inform the registrar of the appointment and furnish the registrar with such information on the matter as the registrar may reasonably require.(b) If the registrar is satisfied that a director, member, trustee or partner does not comply with the requirements as contemplated in paragraph (a) of section 8 (1), the registrar may suspend or withdraw the licence of the provider as contemplated in section 9.


9. Suspension and withdrawal of authorisation.—(1) The registrar may, subject to subsection (2) and irrespective of whether the registrar has taken or followed, or is taking or following, any step or procedure referred to in section 4, at any time suspend or withdraw any licence (including the licence of a licensee under provisional or final suspension) if satisfied, on the basis of available facts and information, that the licensee—

(a)

no longer meets the requirements contemplated in section 8;(b)

did not, when applying for the licence, make a full disclosure of all relevant information to

the registrar, or furnished false or misleading information;(c)

has failed to comply with any other provision of this Act; or(d)

is liable for payment of a levy under section 15A of the Financial Services Board Act, 1990 (Act No. 97 of 1990), an amount or penalty under section 33 (2), a penalty under section 41 (2) and (3) or an administrative sanction under section 6D (2) of the Financial Institutions (Protection of Funds) Act, 2001 (Act No. 28 of 2001), and has failed to pay the said levy, amount or administrative sanction and any interest in respect thereof.(2) (a) Before suspending or withdrawing any licence, the registrar—

(i)may consult any regulatory authority; and(ii)must inform the licensee of the intention to suspend or withdraw and the grounds therefor and must give the licensee a reasonable opportunity to make a submission in response thereto.(b) Where the registrar contemplates the suspension of any licence, the registrar must also inform the licensee of—

(i)the intended period of the suspension; and(ii)any terms to be attached to the suspension, including—(aa)

a prohibition on concluding any new business by the licensee as from the effective date of the suspension and, in relation to unconcluded business, such measures as the registrar may determine for the protection of the interests of clients of the licensee; and(bb)

terms designed to facilitate the lifting of the suspension.(c) The registrar must consider any response received, and may thereafter decide to suspend or withdraw, or not to suspend or withdraw, the licence, and must notify the licensee of the decision.

(d) Where the licence is suspended or withdrawn, the registrar must make known the reasons for the suspension or withdrawal and any terms attached thereto by notice in the Gazette and may make known such information by means of any other appropriate public media.

(3) Notwithstanding the provisions of subsection (2), the registrar may under urgent circumstances, where the registrar is satisfied on reasonable grounds that substantial prejudice to clients or the general public may occur—

(a)

provisionally suspend or withdraw a licence, and inform the licensee of the—(i)grounds therefor; and

(ii)period and terms of suspension as referred to in subsection (2) (b),and give the licensee a reasonable opportunity to respond thereto and to provide reasons why the provisional suspension or withdrawal should be lifted or why the period and terms should be changed; and

(b)

make known such provisional suspension or withdrawal by notice in the Gazette and, if necessary, by means of any other appropriate public media.(4) (a) The registrar must, within a reasonable time after receipt of any response contemplated in subsection (3) (a) consider the response, and may thereafter decide to—

(i)lift the provisional suspension or withdrawal; or(ii)render the suspension or withdrawal final,and must inform the licensee accordingly.

(b) The registrar must make known the terms of and reasons for such final suspension or withdrawal, or the lifting thereof, by notice in the Gazette and, if necessary, in any other appropriate public media.

(5) During any period of suspension, whether provisional or final, the licensee concerned is for the purposes of this Act regarded as a person who is not authorised to act as a financial services provider.

(6) (a) A person whose licence has been withdrawn under this section is debarred for a period specified by the registrar from applying for a new licence.

(b) The registrar may, on good cause shown, vary any such period.

[S. 9 substituted by s. 49 of Act No. 22 of 2008.]

Wording of Sections


10. . . . . . .


Wording of Sections

Wording of Sections s 10 of Act 37 of 2002 prior to amendment by Act 22 of 2008 11. Lapsing of licence.—(1) A licence lapses—

(a)

where the licensee, being a natural person—(i)becomes permanently incapable of carrying on any business due to physical or mental disease or serious injury;(ii)is finally sequestrated; or(iii)dies;(b)

where the licensee, being any other person, is finally liquidated or dissolved;(c)

where the business of the licensee has become dormant; and(d)

in any other case, where the licensee voluntarily and finally surrenders the licence to the registrar.(2) The registrar must be advised in writing by the licensee, any key individual of the licensee, or another person in control of the affairs of the licensee, as the case may be, of the lapsing of a licence and the reasons therefor and the registrar may make known any such lapsing of a licence by notice in the Gazette and, if necessary by means of any other appropriate public media announcement.

[Sub-s. (2) substituted by s. 51 of Act No. 22 of 2008.]

Wording of Sections


12. Exemptions in respect of product suppliers.—(1) The registrar may exempt a product supplier who is authorised or approved under a particular law to conduct business as a financial institution, and who is required to apply for authorisation under section 8, from submitting some or all of the information otherwise required from an applicant: Provided that the product supplier—

(a)

applies for exemption when submitting the application; and(b)

complies with the requirements of the registrar with regard to information still required.(2) Authorisation granted to a product supplier contemplated in subsection (1) is supplementary to, but separate from, the supplier’s authorisation or approval under a particular law as a financial institution.

CHAPTER IIIREPRESENTATIVES OF AUTHORISED FINANCIAL SERVICES PROVIDERS

13. Qualifications of representatives and duties of authorised financial services providers.—(1) A person may not—

(a)

carry on business by rendering financial services to clients for or on behalf of any person who—(i)is not authorised as a financial services provider; and(ii)is not exempted from the application of this Act relating to the rendering of a financial service; or(Date of commencement of para. (a): 30 September, 2004.)

(b)

act as a representative of an authorised financial services provider, unless such person—(i)is able to provide confirmation, certified by the provider, to clients—(aa)

that a service contract or other mandate, to represent the provider, exists; and[Item (aa) substituted by s. 52 (a) of Act No. 22 of 2008.]

Wording of Sections

(bb)

that the provider accepts responsibility for those activities of the representative performed within the scope of, or in the course of implementing, any such contract or mandate;[Item (bb) substituted by s. 52 (a) of Act No. 22 of 2008.]

Wording of Sections

(ii)if debarred as contemplated in section 14, complies with the requirements determined by the registrar, after consultation with the Advisory Committee, by notice in the Gazette, for the reappointment of a debarred person as a representative.[General Note: Requirements for reappointment of debarred representatives determined under Board Notice No. 82 in Government Gazette 25299 of 8 August, 2003.]

(2) An authorised financial services provider must—

(a)at all times be satisfied that the provider’s representatives, and the key individuals of such representatives, are, when rendering a financial service on behalf of the provider, competent to act, and comply with the requirements contemplated in paragraphs (a) and (b) of section 8 (1) and subsection (1) (b) (ii) of this section, where applicable;[Para. (a) substituted by s. 52 (b) of Act No. 22 of 2008.]

Wording of Sections

(b)

take such steps as may be reasonable in the circumstances to ensure that representatives comply with any applicable code of conduct as well as with other applicable laws on conduct of business.(3) The authorised financial services provider must maintain a register of representatives, and key individuals of such representatives, which must be regularly updated and be available to the registrar for reference or inspection purposes.

(4) Such register must—

(a)

contain every representative’s or key individual’s name and business address, and state whether the representative acts for the provider as employee or as mandatory; and(b)

specify the categories in which such representatives are competent to render financial services.(5) The registrar may require information from the authorised financial services provider, including the information referred to in subsection (4), so as to enable the registrar to maintain and continuously update a central register of all representatives and key individuals, which register must be published in any appropriate media.

[Sub-s. (5) substituted by s. 52 (c) of Act No. 22 of 2008.]

Wording of Sections

(6) A person who on the date contemplated in section 7 (1) complies with the requirements of this Act for a representative and on such date acts as employee or mandatory for any person who on or after such date becomes an authorised financial services provider, is, for the purposes of this Act, but subject to the provisions of this Act relating to representatives, regarded as a representative.

Wording of Sections s 13(1)(b)(i)(aa) of Act 37 of 2002 prior to amendment by Act 22 of 2008

Wording of Sections s 13(1)(b)(i)(bb) of Act 37 of 2002 prior to amendment by Act 22 of 2008

Wording of Sections s 13(2)(a) of Act 37 of 2002 prior to amendment by Act 22 of 2008 Wording of Sections s 13(5) of Act 37 of 2002 prior to amendment by Act 22 of 2008

14. Debarment of representatives.—(1) An authorised financial services provider must ensure that any representative of the provider who no longer complies with the requirements

referred to in section 13 (2) (a) or has contravened or failed to comply with any provision of this Act in a material manner, is prohibited by such provider from rendering any new financial service by withdrawing any authority to act on behalf of the provider, and that the representative’s name, and the names of the key individuals of the representative, are removed from the register referred to in section 13 (3): Provided that any such provider must immediately take steps to ensure that the debarment does not prejudice the interest of clients of the representative, and that any unconcluded business of the representative is properly concluded.


Wording of Sections

(2) For the purposes of the imposition of a prohibition contemplated in subsection (1), the authorised financial services provider must have regard to information regarding the conduct of the representative as provided by the registrar, the Ombud or any other interested person.


Wording of Sections

(3) (a) The authorised financial services provider must within a period of 15 days after the removal of the names of a representative and key individuals from the register as contemplated in subsection (1), inform the registrar in writing thereof and provide the registrar with the reasons for the debarment in such format as the registrar may require.

(b) The registrar may make known any such debarment and the reasons therefor by notice in the Gazette or by means of any other appropriate public media.


Wording of Sections




14A. Debarment by registrar.—(1) The registrar may, subject to subsection (2), at any time debar a person, including a representative, for a specified period from rendering financial services if satisfied on the basis of available facts and information that the person—

(a)

does not meet, or no longer meets, the requirements contemplated in section 8 (1) (a); or(b)

has contravened or failed to comply with any provision of this Act.(2) The provisions of section 9 (2), regarding a decision to suspend a licence, apply with the necessary changes to the debarment of a person contemplated in subsection (1).

(3) An authorised financial services provider must within a period of five days after being informed by the registrar of the debarment of a representative or key individual, remove the names of that representative and key individuals from the register as contemplated in section 13 (3).

(4) The registrar may make known any such debarment and the reasons therefor, or the lifting thereof, by notice in the Gazette or by means of any other appropriate public media.

[S. 14A inserted by s. 54 of Act No. 22 of 2008.]

CHAPTER IVCODES OF CONDUCT

15. Publication of codes of conduct.—(1) (a) The registrar must, after consultation with the Advisory Committee and with representative bodies of the financial services industry and client and consumer bodies determined by the Advisory Committee, draft a code of conduct for authorised financial services providers.

(b) The code must, after consultation, be published by notice in the Gazette, and, on any such publication, becomes binding on all authorised financial services providers and representatives referred to therein.

(2) (a) Different codes of conduct may be so drafted in respect of the rendering of a financial service to different categories of clients and of different categories of authorised financial services providers and their operations in different sectors of the financial services industry, and different categories of representatives.

(b) A code of conduct must be drafted for the rendering of a financial service in respect of a deposit referred to in paragraph ( f ) of the definition of “financial product” in section 1 (1) with a term not exceeding 12 months by a provider which is a bank as defined in the Banks Act, 1990 (Act No. 94 of 1990), a mutual bank as defined in the Mutual Banks Act, 1993 (Act No. 124 of 1993), or a co-operative bank as defined in the Co-operative Banks Act, 2007 (Act No. 40 of 2007).


Wording of Sections

[General Note: Specific code of conduct for authorised financial services providers and representatives conducting short-term deposit business published under Board Notice No. 123 in Government Gazette 25629 of 24 October, 2003.]

(3) Such codes of conduct may from time to time be amended or replaced in accordance with the procedure set out in subsection (1).

[General Note: A general code of conduct for administrative and discretionary financial services providers published under Board Notice No. 79 in Government Gazette 25299 of 8 August, 2003 and amended under Notice No. 3196 in Government Gazette 25681 of 6 November, 2003. Authorised financial services providers and their representatives published under Board Notice No. 80 in Government Gazette 25299 of 8 August, 2003.]


16. Principles of code of conduct.—(1) A code of conduct must be drafted in such a manner as to ensure that the clients being rendered financial services will be able to make informed decisions, that their reasonable financial needs regarding financial products will be appropriately and suitably satisfied and that for those purposes authorised financial services providers, and their representatives, are obliged by the provisions of such code to—

(a)

act honestly and fairly, and with due skill, care and diligence, in the interests of clients and the integrity of the financial services industry;(b)

have and employ effectively the resources, procedures and appropriate technological systems for the proper performance of professional activities;(c)

seek from clients appropriate and available information regarding their financial situations, financial product experience and objectives in connection with the financial service required;(d)

act with circumspection and treat clients fairly in a situation of conflicting interests; and(e)

comply with all applicable statutory or common law requirements applicable to the conduct of business.(2) A code of conduct must in particular contain provisions relating to—

(a)

the making of adequate disclosures of relevant material information, including disclosures of actual or potential own interests, in relation to dealings with clients;(b)

adequate and appropriate record-keeping;(c)

avoidance of fraudulent and misleading advertising, canvassing and marketing;(d)

proper safe-keeping, separation and protection of funds and transaction documentation of clients;

(e)

where appropriate, suitable guarantees or professional indemnity or fidelity insurance cover, and mechanisms for adjustments of such guarantees or cover by the registrar in any particular case;[Para. (e) amended by s. 56 of Act No. 22 of 2008.]

Wording of Sections

(eA)

the control or prohibition of incentives given or accepted by a provider; and[Para. (eA) inserted by s. 56 of Act No. 22 of 2008.]

( f )

any other matter which is necessary or expedient to be regulated in such code for the better achievement of the objects of this Act.CHAPTER VDUTIES OF AUTHORISED FINANCIAL SERVICES PROVIDERS

Wording of Sections s 16(2)(e) of Act 37 of 2002 prior to amendment by Act 22 of 2008

17. Compliance officers and compliance arrangements.—(1) (a) Any authorised financial services provider with more than one key individual or one or more representatives must, subject to section 35 (1) (c), appoint one or more compliance officers to monitor compliance with this Act by the provider and such representative or representatives, particularly in accordance with the procedures contemplated in subsection (3), and to take responsibility for liaison with the registrar.

(b) Such person may be any person with suitable qualifications and experience determined by the registrar by notice in the Gazette, after consultation with the Advisory Committee.

[Para. (b) substituted by s. 57 (a) of Act No. 22 of 2008.]

Wording of Sections

[General Note: Qualifications and experience of compliance officers in respect of financial services business determined under Board Notice No. 83 in Government Gazette 25299 of 8 August, 2003.](c) The provisions of section 19 (4), (5) and (6), relating to an auditor of an authorised financial services provider, apply with the necessary changes to a compliance officer.

[Para. (c) substituted by s. 57 (a) of Act No. 22 of 2008.]

Wording of Sections

(2) (a) A compliance officer must be approved by the registrar in accordance with the criteria and guidelines determined by the registrar after consultation with the Advisory

Committee.

(b) The registrar may at any time withdraw the approval if satisfied on the basis of available facts and information that the compliance officer—

(i)has contravened or failed to comply with any provision of this Act; or(ii)no longer complies with the criteria and guidelines contemplated in paragraph (a) of this subsection.(c) The provisions of section 9 (2) regarding a decision to withdraw an authorisation (excluding such provisions relating to periods and terms) apply with the necessary changes to a withdrawal of an approval contemplated in paragraph (b) of this subsection.

(d) The registrar may make known any withdrawal of approval under this subsection and the reasons therefor by notice in the Gazette or by means of any other appropriate public media.


Wording of Sections

[General Note: Criteria and guidelines for the approval of compliance officers determined under Board Notice No. 84 in Government Gazette 25299 of 8 August, 2003.]

(3) An authorised financial services provider must establish and maintain procedures to be followed by the provider and any representative concerned, in order to ensure compliance with this Act.

(4) A compliance officer or, in the absence of such officer, the authorised financial services provider concerned, must submit reports to the registrar in the manner and regarding the matters, as from time to time determined by the registrar by notice in the Gazette for different categories of compliance officers, after consultation with the Advisory Committee.

(5) The provisions of subsections (3) and (4) apply with the necessary changes to any authorised financial services provider who carries on a business with only one key individual or without any representative.


Wording of Sections s 17(1)(c) of Act 37 of 2002 prior to amendment by Act 22 of 2008


18. Maintenance of records.—An authorised financial services provider must, except to the extent exempted by the registrar, maintain records for a minimum period of five years regarding—

(a)

known premature cancellations of transactions or financial products by clients of the provider;(b)

complaints received together with an indication whether or not any such complaint has been resolved;(c)

the continued compliance with the requirements referred to in section 8;(d)

cases of non-compliance with this Act, and the reasons for such non-compliance; and(e)

the continued compliance by representatives with the requirements referred to in section 13 (1) and (2).19. Accounting and audit requirements.—(1) Except to the extent exempted by the registrar, an authorised financial services provider must, in respect of the business carried on by the provider as authorised under the provider’s licence—

(a)

maintain full and proper accounting records on a continual basis, brought up to date monthly; and(b)

annually prepare, in respect of the relevant financial year of the provider, financial statements reflecting—(i)the financial position of the entity at its financial year end;(ii)the results of operations, the receipt and payment of cash and cash equivalent balances;(iii)all changes in equity for the period then ended, and any additional components required in terms of South African Generally Accepted Accounting Practices issued by the Accounting Practices Board or International Financial Reporting Standards issued by the International Accounting Standards Board or a successor body; and(iv)a summary of significant accounting policies and explanatory notes on the matters referred to in paragraphs (i) to (iii);[Para. (b) substituted by s. 58 (a) of Act No. 22 of 2008.]

Wording of Sections

(2) (a) An authorised financial services provider must cause the statements referred to in subsection (1) (b) to be audited and reported on in accordance with auditing pronouncements as defined in section 1 of the Auditing Professions Act, 2005 (Act No. 26 of 2005) by an external auditor approved by the registrar.

(b) The financial statements must—

(i)fairly represent the state of affairs of the provider’s business;(ii)refer to any material matter which has affected or is likely to affect the financial affairs of the provider; and(iii)be submitted by the authorised financial services provider to the registrar not later than four months after the end of the provider’s financial year or such longer period as may be allowed by the registrar.[Sub-s. (2) substituted by s. 58 (b) of Act No. 22 of 2008 with effect from 1 May, 2009 to the extent that it relates to sub-para. (iii).]

Wording of Sections

(3) The authorised financial services provider must maintain records in accordance with subsection (1) (a) in respect of money and financial products held on behalf of clients, and must, in addition to and simultaneously with the financial statements referred to in subsection (2), submit to the registrar a report, by the auditor who performed the audit, which confirms, in the form and manner determined by the registrar by notice in the Gazette for different categories of financial services providers—

(a)

the amount of money and financial products at year end held by the provider on behalf of clients;[Para. (a) substituted by s. 58 (d) of Act No. 22 of 2008.]

Wording of Sections

(b)

that such money and financial products were throughout the financial year kept separate from those of the business of the authorised financial services provider, and report any instance of non-compliance identified in the course of the audit and the extent thereof; and[Para. (b) substituted by s. 58 (d) of Act No. 22 of 2008.]

Wording of Sections(c)

any other information required by the registrar.[Sub-s. (3) substituted by s. 58 (c) of Act No. 22 of 2008.]

Wording of Sections

(4) Despite anything to the contrary contained in any law, the auditor of an authorised financial services provider must report to and inform the registrar in writing of any irregularity or suspected irregularity in the conduct or the affairs of the authorised financial

services provider concerned of which the auditor became aware in performing functions as auditor and which, in the opinion of the auditor, is material.

(5) If the appointment of an auditor of an authorised financial services provider is terminated—

(a)

the auditor must submit to the registrar a statement of what the auditor believes to be the reasons for that termination; and(b)

if the auditor would, but for that termination, have had reason to submit to the registrar a report contemplated in subsection (4), the auditor must submit such a report to the registrar.(6) (a) The registrar may by notice require an authorised financial services provider to terminate the appointment of an auditor of that provider, if the auditor concerned no longer complies with the requirements considered when the auditor was approved by the registrar in terms of subsection (2) (a) or otherwise fails to comply with any provision of this section in a material manner.

(b) A notice contemplated in paragraph (a) takes effect on a date specified in such notice and may only be sent out after the registrar—

(i)has given the authorised financial services provider and the auditor concerned the reasons why the notice is to be issued; and(ii)has given the authorised financial services provider and the auditor concerned a reasonable opportunity to be heard; and(iii)has considered any submissions made by or on behalf of the authorised financial services provider or the auditor concerned.(7) (a) A financial services provider may not change a financial year end without the approval of the registrar.

(b) Despite paragraph (a), the approval of the registrar is not necessary where a change of a financial year end has been approved by another regulatory authority, other than the Registrar of Companies established under the Companies Act, 1973 (Act No. 61 of 1973), regulating the financial soundness of the provider.(c) Where a change of a financial year end was approved by another regulatory authority as is contemplated in paragraph (b), the provider must inform the registrar of that approval within 14 days of the approval being granted.

[Sub-s. (7) added by s. 58 (e) of Act No. 22 of 2008.]

CHAPTER VIENFORCEMENT

Part IOmbud or financial services providers






20. Office of Ombud for Financial Services Providers.—(1) There is an office to be known as the Office of the Ombud for Financial Services Providers.

(2) The functions of the Office are performed by the Ombud for Financial Services Providers.

(3) The objective of the Ombud is to consider and dispose of complaints in a procedurally fair, informal, economical and expeditious manner and by reference to what is equitable in all the circumstances, with due regard to—

(a)

the contractual arrangement or other legal relationship between the complainant and any other party to the complaint; and(b)

the provisions of this Act.(4) When dealing with complaints in terms of sections 27 and 28 the Ombud is independent and must be impartial.

(Date of commencement of s. 20: 8 March, 2003.)

21. Appointment of Ombud and deputy ombuds.—(1) The Board, after consultation with the Advisory Committee—

(a)

must appoint as Ombud a person qualified in law and who possesses adequate knowledge of the rendering of financial services;(b)

may appoint one or more persons qualified in law and who possess adequate knowledge of the rendering of financial services, as deputy ombud.(2) The remuneration and other terms of appointment of the Ombud and a deputy ombud

must be determined by the Board.

(3) The Ombud or deputy ombud may at any time resign by submitting a written resignation to the Board at least three calendar months prior to the intended date of vacation of office, unless the Board allows a shorter period.

(4) The Board may on good cause shown, after consultation with the Advisory Committee, remove the Ombud or a deputy ombud from office on the ground of misbehaviour, incapacity or incompetence, after affording the person concerned a reasonable opportunity to be heard.


22. Funding of Office.—(1) The funds of the Office consist of—

(a)

funds provided by the Board on the basis of a budget submitted by the Ombud to the Board and approved by the latter; and(b)

funds accruing to the Office from any other source.(2) The Ombud must deposit all funds in an account opened with a bank registered under the Banks Act, 1990 (Act No. 94 of 1990).

(3) The Ombud must utilise such funds for the defrayal of expenses incurred in the performance of functions under this Act, and may invest funds which are not required for immediate use.

(4) The financial year of the Ombud ends on 31 March in every year.

(5) Funds standing to the credit of the Ombud in the account mentioned in subsection (2) at the end of the financial year, as well as funds invested under subsection (3), must be carried forward to the next financial year.


23. Accountability.—(1) The Ombud is the accounting officer in respect of all funds received and all payments made in respect of expenses incurred by the Office.(2) The Ombud as accounting officer must—

(a)

keep a full and correct record of all funds received and payments made, and of all assets, liabilities and financial transactions of the Office;(b)

as soon as is practicable, but not later than three months after the end of every financial year, prepare annual financial statements reflecting, with appropriate particulars, all funds received and payments made during, and all such assets, liabilities and transactions at the end of, the relevant financial year.

(3) The records and financial statements mentioned in subsection (2) must be audited by the Auditor-General.


24. General administrative powers of Ombud.—The Ombud may for the performance of functions in the Office and as a charge against or for the benefit of the funds of the Office, as the case may be—

(a)

hire, purchase or otherwise acquire property, and let, sell or otherwise dispose of property so purchased or acquired;(b)

enter into an agreement with any person for the performance of any specific act or function or the rendering of specific services;(c)

insure the Office against any loss, damage, risk or liability;(d)

employ persons to assist the Ombud, determine their terms of appointment and, subject to such conditions as may be determined by the Ombud, delegate or assign to any such employee, including a deputy ombud, any administrative function vesting in the Ombud in terms of this Part;(e)

obtain such professional advice as may reasonably be required; and( f )

in general, do anything which is necessary or expedient for the achievement of the objective of the Ombud.(Date of commencement of s. 24: 8 March, 2003.)

25. Disestablishment and liquidation of Office.—(1) The Office may not be disestablished or liquidated except by an Act of Parliament.(2) In the event of any such disestablishment or liquidation, the surplus assets of the Office (if any) accrue to the Board.


26. Powers of Board.—(1) The Board may, after consultation with the Advisory Committee, make rules, including different rules in respect of different categories of complaints or investigations by the Ombud, regarding—

(a)

(i)any matter which is required or permitted under this Act to be regulated by rule;

(ii)the category of persons qualifying as complainants;(iii)the type of complaint justiciable by the Ombud, including a complaint relating to a financial service rendered by a person not authorised as a financial services provider or a person acting on behalf of such first-mentioned person;(iv)the rights of complainants in connection with complaints, including the manner of submitting a complaint to the authorised financial services provider or representative concerned;(v)the rights and duties of any such provider or representative on receipt of any complaint, particularly in connection with the furnishing of replies to the complainant;(vi)the rights of a complainant to submit a complaint to the Ombud where the complainant is not satisfied with any reply received from the provider or representative concerned;(vii)the circumstances under which a complaint may be dismissed without consideration of its merits;(viii)the power of the Ombud to fix a time limit for any aspect of the proceedings before the Ombud and to extend a time limit;(b)

the payment to the Office by the authorised financial services provider or representative involved in any complaint submitted to the Ombud, of case fees in respect of the consideration of the complaint by the Ombud;(c)

liaison between the Ombud and the registrar, and administrative duties of those functionaries regarding mutual administrative support, exchange of information and reports, other regular consultations and avoidance of overlapping of their respective functions; and(d)

any other administrative or procedural matter necessary or expedient for the better achievement of the objects of this Part, but which is not inconsistent with a provision of this Act.(2) The Board must—

(a)

ensure that no rule made under subsection (1) detracts from or affects the independence of the Ombud in any material way;(b)

publish rules made under subsection (1) in the Gazette.(Date of commencement of s. 26: 8 March, 2003.)

[General Note: Rules on proceedings of the Office of the Ombud for Financial Services Providers published under Board Notice No. 81 in Government Gazette 25299 of 8 August, 2003.]

27. Receipt of complaints, prescription, jurisdiction and investigation.—(1) On submission of a complaint to the Office, the Ombud must—

(a)

determine whether the requirements of the rules contemplated in section 26 (1) (a) (iv) have been complied with;(b)

in the case of any non-compliance, act in accordance with the rules made under that section; and(c)

otherwise officially receive the complaint if it qualifies as a complaint.(2) Official receipt of a complaint by the Ombud suspends the running of prescription in terms of the Prescription Act, 1969 (Act No. 68 of 1969), for the period after such receipt of the complaint until the complaint has either been withdrawn, or determined by the Ombud or the board of appeal, as the case may be.

(3) The following jurisdictional provisions apply to the Ombud in respect of the investigation of complaints:

(a)

(i)The Ombud must decline to investigate any complaint which relates to an act or omission which occurred on or after the date of commencement of this Act but on a date more than three years before the date of receipt of such complaint by the Office.(ii)Where the complainant was unaware of the occurrence of the act or omission contemplated in subparagraph (i), the period of three years commences on the date on which the complainant became aware or ought reasonably to have become aware of such occurrence, whichever occurs first.(b)(i)The Ombud must decline to investigate any complaint if, before the date of official receipt of the complaint, proceedings have been instituted by the complainant in any Court in respect of a matter which would constitute the subject of the investigation.(ii)Where any proceedings contemplated in subparagraph (i) are instituted during any investigation by the Ombud, such investigation must not be proceeded with.(c)

The Ombud may on reasonable grounds determine that it is more appropriate that the complaint be dealt with by a Court or through any other available dispute resolution process, and decline to entertain the complaint.(4) The Ombud must not proceed to investigate a complaint officially received, unless the Ombud—

(a)

has in writing informed every other interested party to the complaint of the receipt thereof;(b)

is satisfied that all interested parties have been provided with such particulars as will enable the parties to respond thereto; and(c)

has provided all interested parties the opportunity to submit a response to the complaint.(5) The Ombud—

(a)

may, in investigating or determining an officially received complaint, follow and implement any procedure (including mediation) which the Ombud deems appropriate, and may allow any party the right of legal representation;(b)

must, in the first instance, explore any reasonable prospect of resolving a complaint by a conciliated settlement acceptable to all parties;(c)

may, in order to resolve a complaint speedily by conciliation, make a recommendation to the parties, requiring them to confirm whether or not they accept the recommendation and, where the recommendation is not accepted by a party, requiring that party to give reasons for not accepting it: Provided that where the parties accept the recommendation, such recommendation has the effect of a final determination by the Ombud, contemplated in section 28 (1);(d)

may, in a manner that the Ombud deems appropriate, delineate the functions of investigation and determination between various functionaries of the Office;(e)may, on terms specified by the Ombud, mandate any person or tribunal to perform any of the functions referred to in paragraph (d).(6) For the purposes of any investigation or determination by the Ombud, the provisions of the Commissions Act, 1947 (Act No. 8 of 1947), regarding the summoning and examination of persons and the administering of oaths or affirmations to them, the calling for the production of books, documents and objects, and offences by witnesses, apply with the necessary changes.


28. Determinations by Ombud.—(1) The Ombud must in any case where a matter has not been settled or a recommendation referred to in section 27 (5) (c) has not been accepted by all parties concerned, make a final determination, which may include—

(a)

the dismissal of the complaint; or(b)

the upholding of the complaint, wholly or partially, in which case—(i)the complainant may be awarded an amount as fair compensation for any financial prejudice or damage suffered;(ii)a direction may be issued that the authorised financial services provider, representative or other party concerned take such steps in relation to the complaint as the Ombud deems appropriate and just;(iii)the Ombud may make any other order which a Court may make.(2) (a) A monetary award may provide for the amount payable to bear interest at a rate and as from a date determined by the Ombud.

(b) The Board may by rule determine—

(i)the maximum monetary award for a particular kind of financial prejudice or damage;(ii)different maximum monetary awards for different categories of complaints;(iii)the granting of costs, including costs against a complainant in favour of the Office or the respondent if in the opinion of the Ombud—(aa)

the conduct of the complainant was improper or unreasonable; or(bb)

the complainant was responsible for an unreasonable delay in the finalisation of the relevant investigation: Provided that an amount payable under a cost award bears interest at a rate and as from a date determined by the Ombud.(3) Any award of interest by the Ombud in terms of subsection (2) may not exceed the rate which a Court would have been entitled to award, had the matter been heard by a Court.

(4) (a) The Ombud must reduce a determination to writing, including all the reasons therefor, sign the determination, and send copies thereof to the registrar and all parties concerned with the complaint and, if no notice of appeal to the board of appeal has been lodged within the period required therefor, to the clerk or registrar of court which would have had jurisdiction in the matter had it been heard by a Court.

(b) Where a notice of appeal has been lodged, the Ombud must send a copy of the final decision of the board of appeal to any such clerk or registrar.

(5) A determination—

(a)

or a final decision of the board of appeal, as the case may be, is regarded as a civil judgment of a Court, had the matter in question been heard by a Court, and must be so noted by the clerk or registrar, as the case may be, of that Court;(b)

is only appealable to the board of appeal—(i)with the leave of the Ombud after taking into consideration—(aa)

the complexity of the matter; or(bb)

the reasonable likelihood that the board of appeal may reach a different conclusion; or(ii)if the Ombud refuses leave to appeal, with the permission of the chairperson of the board of appeal.(6) (a) A writ of execution may, in the case of a determination or a final decision of the board of appeal amounting to a monetary award, be issued by the clerk or the registrar referred to in subsection (3) and may be executed by the sheriff of such Court after expiration of a period of two weeks after the date of the determination or of the final decision of the board of appeal, as the case may be.

(b) Any other determination must be given effect to in accordance with the applicable procedures of a Court after expiration of a period of two weeks after the date of the determination or of the final decision of the board of appeal.


29. Record-keeping.—(1) The Ombud must keep proper files and records in respect of complaints as well as a record of any determination proceedings conducted in terms of section 28.

(2) The registrar has, for the purposes of the performance of the registrar’s functions under this or any other law, access to the Ombud’s files and records and may without further proof rely on a copy of any record of proceedings signed by the Ombud.

(3) Any interested person may, subject to the discretion of the Ombud and applicable rules of confidentiality, obtain a copy of any record on payment of a fee determined by the Ombud.


30. Report of Ombud.—(1) The Ombud must during every year, within six months after the end of the financial year of the Ombud, submit a report to the Board on the affairs and functions of the Ombud during the financial year in question, including the annual financial statements referred to in section 23 (2) (b).

(2) The Ombud must at the same time submit a copy of the report to the Minister.


31. Penalties.—Any person who—

(a)

commits any act in respect of the Ombud or an investigation by the Ombud which, if committed in respect of a court of law, would have constituted contempt of court, is guilty of an offence and liable on conviction to any penalty which may be imposed on a conviction of contempt of court; or(b)

(i)anticipates a determination of the Ombud in any manner calculated to influence the determination; or(ii)wilfully interrupts any proceedings conducted by the Ombud, is guilty of an offence and liable on conviction to a fine or to imprisonment for a period not exceeding one year.


32. Promotion of client education by registrar.—The registrar may take any steps conducive to client education and the promotion of awareness of the nature and availability of the Ombud and other enforcement measures established by or in terms of this Act, including arrangements with the Ombud, representative bodies of the financial services industry, client and consumer bodies, or product suppliers and authorised financial services providers and their representatives to assist in the disclosure of information to the general public on matters dealt with in this Act.

Part IIOther enforcement measures

33. Civil remedies.—(1) The registrar may, when satisfied on the basis of available facts and information that a person has contravened or not complied with any provision of this Act, or is likely so to contravene or not to comply, apply to a Court for an order restraining such person from continuing to commit any such act or omission or from committing it in future, and requiring the person to take such remedial steps as the Court deems necessary to rectify the consequences of the act or omission, including consequences which prejudiced or may prejudice any client.

(2) The registrar may institute action in a Court against any person who has contravened or not complied with any provision of this Act, for payment of—

(a)

an amount determined by the Court as compensation for losses suffered by any other person in consequence of such contravention or non-compliance;(b)

a penalty for punitive purposes in a sum determined in the discretion of the Court;


Wording of Sections

(c)

interest; and(d)

costs of suit on such scale as may be determined by the Court.(3) Any amount recovered by the registrar in terms of subsection (2) must be deposited by the registrar directly into a specially designated trust account established by the registrar with an appropriate financial institution, and thereupon—

(a)

the registrar is, as a first charge against the trust account, entitled to reimbursement of all expenses reasonably incurred in bringing proceedings under subsection (2) and in administering the distributions made to persons in terms of subsection (5);(b)

the balance, if any (hereinafter referred to as the “distributable balance”) must be distributed by the registrar to the persons referred to in subsection (5), any funds remaining, accruing to the registrar in the registrar’s official capacity.(4) Any amount not claimed within three years from the date of the first distribution of payments, accrues to the registrar in the registrar’s official capacity.

(5) The distributable balance must be distributed on a pro rata basis—

(a)

to all persons who prove to the reasonable satisfaction of the registrar that they are persons who suffered losses as contemplated in subsection (2); and(b)

to the extent of the losses contemplated in subsection (2):Provided that no money may be distributed to a person who has contravened or failed to comply with any provision of this Act.


Wording of Sections

(6) A Court issuing any order under this section must order it to be published in the Gazette and by such other appropriate public media announcement as the Court considers appropriate.

(7) The registrar may withdraw, abandon or compromise any civil proceedings instituted under this section, but any agreement or compromise must be made an order of Court and the amount of any payment made in terms of any such compromise must be published in the Gazette and by such other public media announcement as the Court considers appropriate.

(8) Where civil proceedings have not been instituted, any agreement or settlement (if any) may, on application to the Court by the registrar after due notice to the other party, be made an order of Court and must be published in the Gazette and by such other public media announcement as the Court considers appropriate.



34. Undesirable practices.—(1) Subject to subsections (2) and (3), the registrar may, after consultation with the Advisory Committee, by notice in the Gazette declare a particular business practice to be undesirable for all or a category of authorised financial services providers, or any such provider.

(2) The following principles must guide the registrar in considering whether or not a declaration contemplated in subsection (1) should be made:

(a)

That the practice concerned, directly or indirectly, has or is likely to have the effect of—(i)harming the relations between authorised financial services providers or any category of such providers, or any such provider, and clients or the general public;(ii)unreasonably prejudicing any client;(iii)deceiving any client; or(iv)unfairly affecting any client; and(b)

that if the practice is allowed to continue, one or more objects of this Act will, or is likely to, be defeated.(3) The registrar may not make such a declaration unless the registrar has by notice in the Gazette published an intention to make the declaration, giving reasons therefor, and invited interested persons to make written representations thereanent so as to reach the registrar within 21 days after the date of publication of that notice.

(4) The authorised financial services provider concerned may not, on or after the date of the publication of a notice referred to in subsection (1), carry on the business practice concerned.

(5) The registrar may direct an authorised financial services provider who, on or after the date of the publication of a notice referred to in subsection (1), carries on the business practice concerned in contravention of that notice, to rectify to the satisfaction of the registrar anything which was caused by or arose out of the carrying on of the business practice concerned: Provided that the registrar may not make an order contemplated in section 6D (2) (b) of the Financial Institutions (Protection of Funds) Act, 2001 (Act No. 28 of 2001).

[Sub-s. (5) substituted by s. 60 (a) of Act No. 22 of 2008.]

Wording of Sections

(6) An authorised financial services provider concerned who is under subsection (5) directed to rectify anything, must do so within 60 days after such direction is issued.


Wording of Sections



35. Regulations.—(1) The Minister may by notice in the Gazette, after consultation with the registrar and the Advisory Committee, make regulations relating to—

(a)

any matter which is required or permitted to be prescribed under this Act;(b)

a prohibition on—(i)canvassing for, or marketing or advertising (whether within or outside the Republic) of any business relating to the rendering of financial services by any person who is not an authorised financial services provider or a representative of such a provider;(ii)the publication by any person, who is not an authorised financial services provider or a representative of such a provider, of any advertisement, communication or announcement directed to clients and which indicates that such person is an authorised financial services provider or a representative of such a provider; and(iii)the use by any person who is not an authorised financial provider or a representative of any such provider, of any name, title or designation indicating that the person is an authorised financial services provider or a representative of such a provider;(c)

compliance arrangements, compliance monitoring systems and keeping of records;(d)

powers of the registrar to call for information from any person to which this Act applies, including the powers of the Court to issue orders, on application by the registrar, to enforce obligations in that regard; and(e)

generally, any matter which it is expedient or necessary to prescribe for the better achievement of the objects of this Act, the generality of this provision not being restricted by the provisions of any foregoing paragraph.(2) The regulations may provide for offences in cases of contravention or non-compliance with the provisions thereof, and for penalties not exceeding a fine of R500 000 or imprisonment for a period not exceeding five years or to both such fine and such imprisonment.

(3) Different regulations may be made in respect of different matters or categories of persons.

36. Offences and penalties.—Any person who—

(a)

contravenes or fails to comply with a provision of section 7 (1) or (3), 8 (8), 8 (10) (a), 13 (1) or (2), 14 (1), 17 (4), 18, 19 (2), 19 (4) or 34 (4) or (6);[Para. (a) substituted by s. 61 (a) of Act No. 22 of 2008.]

Wording of Sections

(b)

in any application in terms of this Act, deliberately makes a misleading, false or deceptive statement, or conceals any material fact, (c)

in the execution of duties imposed by this Act gives an appointed auditor or compliance officer information which is false, misleading or conceals any material fact; or[Para. (c) added by s. 61 (b) of Act No. 22 of 2008.]

(d)

is not a representative appointed or mandated by an authorised financial services provider in accordance with the provisions of this Act, and who in any way declares, pretends, gives out, maintains or professes to be a person who is authorised to render financial services to clients on the basis that the person is appointed or mandated as a representative by another such first-mentioned representative;[Para. (d) added by s. 61 (b) of Act No. 22 of 2008.]

is guilty of an offence and is on conviction liable to a fine not exceeding Rl 000 000 or to imprisonment for a period not exceeding 10 years, or to both such fine and such imprisonment.

Wording of Sections s 36(a) of Act 37 of 2002 prior to amendment by Act 22 of 2008

37. Consideration of quantum of fines and penalties.—(1) In the consideration of the quantum of any penalty under section 36, the Court must take into consideration any award made or to be made under section 33, from the same cause.

(2) In the consideration of the quantum of any award under section 33, the Court must take into account any penalty imposed or to be imposed under section 36, from the same cause.

38. Voluntary sequestration, winding-up and closure.—No—

(a)

application for the acceptance of the voluntary surrender of the estate, in terms of section 3 of the Insolvency Act, 1936 (Act No. 24 of 1936), of;(b)

special resolution relating to the winding-up, as contemplated in section 349 of the Companies Act, 1973 (Act No. 61 of 1973), and registered in terms of that Act, of;(c)

written resolution relating to the winding-up, as contemplated in section 67 of the Close Corporations Act, 1984 (Act No. 69 of 1984), and registered in terms of that section, of; and(d)

voluntary closure of business by, any authorised financial services provider, or representative of such provider, and no special resolution in terms of the constitution of such a provider or representative which is not a company, to close its business, have legal force—

(i)unless a copy or notice thereof has been lodged with the registrar and the registrar has, by notice to the provider or representative concerned, as the case may be, declared that arrangements satisfactory to the registrar have been made to meet all liabilities under transactions entered into with clients prior to sequestration, winding-up or closure, as the case may be; or(ii)if the registrar, by notice to the provider or representative concerned, as the case may be, declares that the application, resolution or closure, as the case may be, is contrary to this Act.39. Right of appeal.—Any person who feels aggrieved by any decision by the registrar or the Ombud under this Act which affects that person, may appeal to the board of appeal established by section 26 (1) of the Financial Services Board Act, in respect of which appeal the said section 26 applies with the necessary changes.

CHAPTER VIIMISCELLANEOUS

40. Saving of rights.—No provision of this Act, and no act performed under or in terms of any such provision, may be construed as affecting any right of a client, or other affected person, to seek appropriate legal redress in terms of common law or any other statutory law, and whether relating to civil or criminal matters, in respect of the rendering of any financial service by an authorised financial services provider, or representative of such provider, or any act of a person who is not an authorised financial services provider or a representative of such a provider.

41. Fees and penalties.—(1) (a) The Minister must, after consultation with the registrar, by notice in the Gazette, determine the fees payable to the registrar by any person, or category of persons, seeking a decision or the performance of any other act by the registrar under this Act and referred to in section 3 (1).

(b) The fees are payable in the manner, and are subject to the requirements, determined by the registrar by notice in the Gazette.

[General Note: Fees determined under Government Notice No. 536 in Government Gazette 24761 of 15 April, 2003.]

(2) (a) A person who fails to furnish the registrar with a return, information or document, as provided by this Act, within the period specified or any extension thereof, is, irrespective of any criminal proceedings instituted against the person under this Act, but subject to paragraph (b), liable to a penalty not exceeding R1 000 or any greater amount prescribed, for every day during which the failure continues, unless the registrar, on good cause shown, waives the penalty or any part thereof.

(b) The penalty may be imposed by the registrar by notice to the person concerned, and such imposition must be preceded by a procedure giving such person a reasonable opportunity to be heard, and takes effect on a date specified in such notice which may be a date prior to the date of the notice.

(3) (a) A person who is liable to pay the fees or a penalty contemplated in subsection (1) (a) or (2) (a), respectively, and who fails to pay the amount due on the date or within the period specified, must pay interest on the amount outstanding and on unpaid interest at such rate, and calculated in such manner as may be determined by the Minister from time to time in respect of debts due to the state.(b) The fees and penalties, and interest owed in respect thereof, are regarded as debts due to the Board and may be recovered by the Board in a Court.

42. Exchange of information.—The registrar may disclose information obtained in the course of performing functions in terms of this Act, unless such disclosure will not be in the public interest, but subject to any guidelines issued by the Board to the registrar—

(a)

to any department of state or organ of state as defined in section 239 of the Constitution of the Republic of South Africa, 1996 (Act No. 108 of 1996), foreign financial or investment services regulatory or supervisory authority, or any other regulatory or supervisory authority for financial or investment services in the Republic, including the Registrar of Medical Schemes and a representative body of the financial services industry or self-regulatory organisation approved by the Board, if such information is likely to be of interest to the relevant department or organ of state, regulatory or supervisory authority, Registrar of Medical Schemes, representative body or self-regulatory organisation; or(b)

to any foreign financial or investment services regulatory or supervisory authority, where the information is required in terms of any agreement, communiqué or memorandum of understanding concluded by the Board or the registrar with any such authority:

Provided that the Board or the registrar may impose conditions relating to the use of any information and the preservation of confidentiality in respect thereof.

43. . . . . . .


Wording of Sections


44. Exemptions by registrar and Minister.—(1) The registrar may on or after the commencement of this Act, but prior to the date determined by the Minister in terms of section 7 (1), exempt any person or category of persons from the provisions of that section if the registrar is satisfied that—

(a)

the rendering of any financial service by the applicant is already partially or wholly regulated by any other law; or(b)

the application of the said section to the applicant will cause the applicant or clients of the applicant financial or other hardship or prejudice; and(c)

the granting of the exemption will not—(i)conflict with the public interest;(ii)prejudice the interests of clients; and(iii)frustrate the achievement of the objects of this Act.(2) The registrar—

(a)

having regard to the factors mentioned in subsection (1), may attach to any exemption so granted reasonable requirements or impose reasonable conditions with which the applicant must comply either before or after the effective date of the exemption in the manner and during the period specified by the registrar; and(b)

must determine the period for which the exemption will be valid.(3) An exemption in respect of which a person has to comply with requirements or conditions, lapses whenever the person contravenes or fails to comply with any such requirement or condition: Provided that the registrar may on application condone any such contravention or failure and determine reasonable requirements or conditions with which the applicant must comply on or after resumption of the exemption as if such requirements or

conditions had been attached or imposed on the first granting of the exemption.

(4) (a) The registrar may in any case not provided for in this Act, on reasonable grounds, on application or on the registrar’s own initiative by notice in the Gazette, exempt any person or category of persons from any provision of this Act.

(b) The provisions of subsections (1), (2) and (3) apply with the necessary changes in respect of any exemption contemplated in paragraph (a).

[General Note: Exemption of financial services providers as regards representatives published under Board Notice No. 95, exemption of certain financial services providers from requirements pertaining to audited financial statements and financial soundness published under Board Notice No. 96 and exemption of investment managers and linked investment sevices providers, and their related functionaries, from certain fit and proper requirements published under No. 97 in Government Gazette 25514 of 30 September, 2003. Exemption of authorised financial services providers and representatives conducting short-term deposit business from certain fit and proper requirements and the general code when rendering financial services relating to money market funds published under Board Notice No. 131 in Government Gazette 25682 of 6 November, 2003. Exemption published under Board Notice No. 35 in Government Gazette 28809 of 10 May, 2006.]

(5) The Minister, after consultation with the registrar, may, on such conditions as the Minister may determine, by notice in the Gazette exempt a financial services provider or representative, or category of financial services providers or representatives, from any provision of the Policyholder Protection Rules made under section 62 of the Long-term Insurance Act, 1998 (Act No. 52 of 1998), and section 55 of the Short-term Insurance Act, 1998 (Act No. 53 of 1998), respectively.

45. Exemptions, and amendment or repeal of laws.—(1) The provisions of this Act do not apply to the rendering of financial services by—

(a)

(i)any “authorised user”, “clearing house”, “central securities depository” or “participant” as defined in section 1 of the Securities Services Act, 2002, or exchange licensed under section 10 of that Act;(ii)a manager as defined in section 1 of the Collective Investment Schemes Control Act, 2002;(iii)a person performing the functions referred to in section 13B of the Pension Funds Act, 1956 (Act No. 24 of 1956), if such person complies with the requirements and conditions contemplated in that section; or(iv)a person carrying on the business referred to in section 58 of the Medical Schemes Act, 1998 (Act No. 131 of 1998), if such person complies with the requirements contemplated in that section, to the extent that the rendering of financial services is regulated by or under those Acts, respectively;

(b)

(i)the executor, administrator or trustee of any deceased or insolvent estate, or a person acting on behalf of such executor, administrator or trustee;(ii)the curator of a person under curatorship, or a person acting on behalf of such curator;(iii)the liquidator or judicial manager of a company in liquidation or under judicial management, or a person acting on behalf of such liquidator or judicial manager;(iv)the trustee of an inter vivos trust as defined in section 1 of the Trust Property Control Act, 1988 (Act No. 57 of 1988), not being a business trust created for the purpose of profit-making achieved through the combination of capital contributed by the beneficiaries of the trust and through the administration or management of the capital by trustees on behalf of and for the benefit of the beneficiaries, or a person acting on behalf of such first-mentioned trustee;(v)the parent, tutor or guardian of a minor, or a person acting on behalf of such parent, tutor or guardian, unless the financial services are rendered as a regular feature of any such person’s business; or

(c)

any other trustee or custodian appointed under any law to the extent that the rendering of such services is regulated by or under such law.(2) (a) The law referred to in item I of the Schedule is hereby amended to the extent indicated in the fourth column of the Schedule.

(b) The laws referred to in item II of the Schedule are hereby, with effect from the date determined in terms of section 7 (1), amended or repealed to the extent indicated in the fourth column of the Schedule: Provided that any unconcluded business of any financial services provider in terms of such law on that date may be concluded within the prescribed period as if any such amendment or repeal has not taken effect.

(General Note: Date determined in terms of section 7 (1) as 30 September, 2004 under Government Notice No. 270 in Government Gazette 26080 of 5 March, 2004.)

(3) Until such time as the Collective Investment Schemes Control Act, 2002, referred to in sections 1 (1) and 45 (1) (a) (ii) of this Act comes into operation, any reference in this Act to—

(a)

a collective investment scheme and manager must be construed as references to a unit trust scheme and management company, and scheme and manager, referred to in the Unit Trusts Control Act, 1981 (Act No. 54 of 1981), and the Participation Bonds Act, 1981 (Act No. 55 of 1981), respectively; and(b)

any word or expression defined in the Unit Trusts Control Act, 1981, and the Participation Bonds Act, 1981, unless clearly inappropriate or inconsistent with this Act, has the meaning so defined. (4) Until such time as the Securities Services Act, 2002, referred to in sections 1 (1) and 45 (1) (a) (i) of this Act comes into operation, any reference in this Act to—

(a)

an authorised user, exchange, a clearing house, central securities depository and participant, must be construed as references to a member, stock exchange, clearing house, financial exchange, recognised clearing house, central securities depository and depositary institution referred to in the Stock Exchanges Control Act, 1985 (Act No. 1 of 1985), Financial Markets Control Act, 1989 (Act No. 55 of 1989), and Custody and Administration of Securities Act, 1992 (Act No. 85 of 1992), respectively; and(b)

any word or expression defined in the Stock Exchanges Control Act, 1985, Financial Markets Control Act, 1989, and Custody and Administration of Securities Act, 1992, unless clearly inappropriate or inconsistent with this Act, has the meaning so defined.Repealed Act Act 54 of 1981 has been repealed by s 117 of Act 45 of 2002





46. Commencement and short title.—This Act is called the Financial Advisory and Intermediary Service Act, 2002, and comes into operation on a date fixed by the President by proclamation in the Gazette.

COMMENCEMENT OF THIS ACT

Date of commencement The whole Act/Sections Proclamation/NoticeNo. Government Gazette Date of Government Gazette 15 November, 2002

The whole Act, except ss. 13 (1) (a), 20-31 R.81 24075 15 November, 2002 8 March, 2003 Ss. 20-31 R.21 25027 7 March, 2003 30 September, 2004 S. 13 (1) (a) 35 26496 2 July, 2004 30 September, 2004 Item II of the Schedule 270 (Date determined in terms of s. 7 (1)) 26080 5 March, 2004

SCHEDULELAWS AMENDED OR REPEALED

(Section 45)

(Date of commencement of item II of the Schedule: 30 September, 2004.)

Item No. and year of Act Short title Extent of repeal or amendment I Act No. 97 of 1990 Financial Services Board Act, 1990 Amends section 1 by the addition of paragraph (a) (xii) to the definition of “financial institution”. II (a) Act No. 1 of 1985 Stock Exchanges Control Act, 1985 1. Amends section 4 as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) deletes subsections (1A), (2), (3), (4), (5), (6) and (7) (c).

2. Amends section 12 (1) by substituting paragraph (d). 3. Amends section 39 by deleting subsections (2), (2A) and (2B). 4. Amends section 45 (1) as follows:—paragraph (a) deletes paragraph (a) (iii); paragraph (b) deletes the word “or” at the end of paragraph (b) (ii) and paragraph (b) (iii); and paragraph (c) substitutes the words following paragraph (b) (iii). 5. Amends section 47 (1) by deleting paragraph (b). 6. Amends section 48 (1) by substituting paragraph (a). 7. Amends section 50 by substituting the heading and subsection (1). II (b) Act No. 55 of 1989 Financial Markets Control Act, 1989 1. Amends section 5 as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) deletes subsections (1A), (2), (3), (4), (5), (6) and (7) (c). 2. Amends section 17 (1) as follows:—paragraph (a) substitutes paragraph (dC); and paragraph (b) substitutes paragraph (lB). 3. Amends section 21A by deleting subsections (2), (2A) and (2B).

4. Amends section 26 (1) as follows—paragraph (a) deletes paragraph (a) (iii); paragraph (b) deletes the word “or” at the end of paragraph (b) (ii) and paragraph (b) (iii); and paragraph (c) substitutes the words following paragraph (b) (iii). 5. Amends section 28 by deleting paragraph (c). 6. Amends section 29 as follows:—paragraph (a) substitutes subsection (1) (b); and paragraph (b) substitutes subsection (2). 7. Substitutes section 30. 8. Amends section 31 by substituting the heading and subsection (1). II (c) Act No. 140 of 1992 Drugs and Drug Trafficking Act, 1992 1. Amends section 10 (3) by substituting paragraphs (a) and (b)—see title CRIMINAL LAW AND PROCEDURE.



DRUGS AND DRUG TRAFFICKING ACT,NO. 140 OF 1992

(Prior to amendment by Act No. 37 of 2002)

Section 10 (3) (a) and (b)

(a)

any stock-broker as defined in section 1 of the Stock Exchanges Control Act, 1985 (Act No. 1 of 1985), or any person contemplated in paragraph (d), (e) or ( f ) of section 4 (1) of that Act; or(b)

any financial instrument trader as defined in section 1 of the Financial Markets Control Act, 1989 (Act No. 55 of 1989), or any person contemplated in paragraph ( f ), (g) or (h) of section 5 (1) of that Act,Repealed Act Act 1 of 1985 has been repealed by s 117 of Act 36 of 2004




DRUGS AND DRUG TRAFFICKING ACT,NO. 140 OF 1992(Prior to amendment by Act No. 37 of 2002)

Section 10 (3) (a) and (b)

(a)

any stock-broker as defined in section 1 of the Stock Exchanges Control Act, 1985 (Act No. 1 of 1985), or any person contemplated in paragraph (d), (e) or ( f ) of section 4 (1) of that Act; or(b)

any financial instrument trader as defined in section 1 of the Financial Markets Control Act, 1989 (Act No. 55 of 1989), or any person contemplated in paragraph ( f ), (g) or (h) of section 5 (1) of that Act,Repealed Act Act 1 of 1985 has been repealed by s 117 of Act 36 of 2004




(Prior to amendment by Government Notice No. R.521 of 2001)

Schedule 1

PART I


N-Acetylanthranilic acid.

Ephedrine.

Ergometrine.

Ergotamine.

Isosafrole.

Lysergic acid.

3,4-Methylenedioxyphenyl-2-propanone.

1-phenyl-2-propanone.Piperonal.

Pseudoephedrine.

Safrole.


Schedule 2

PART I

Dependence-Producing Substances


Amobarbital, cyclobarbital and pentobarbital, except preparations and mixtures containing not more than 30 milligrams per minimum recommended or prescribed dose when intended for continued use in asthma or containing not more than 50 milligrams per minimum recommended or prescribed dose when intended for continued use in epilepsy.

Buprenorphine.

Butalbital.

Cathine ((+)-norpseudoephedrine), except preparations and mixtures containing 50 milligrams or less of cathine per dosage unit.

Chlorphentermine.


Flunitrazepam.

Gluthethimide.

Meptazinol.

Pentazocine.

Tiletamine.

2. Unless expressly excluded, all substances included in this Part include the following:

(a)

The salts and esters of the specified substances, where the existence of such salts and esters is possible; and(b)

all preparations and mixtures of the specified substances.PART II

Dangerous Dependence-Producing Substances


Acetorphine.

Acetyldihydrocodeine, except preparations and mixtures containing not more than 20 milligrams of acetyldihydrocodeine per recommended or prescribed dose.

Acetylmethadol.

Alfentanil.

Allylprodine.

Alphacetylmethadol.

Alphameprodine.

Alphamethadol.

Alphaprodine.

Anileridine.

Benzethidine.

Benzphetamine.

Benzylmorphine.

Betacetylmethadol.

Betameprodine.

Betamethadol.

Betaprodine.

Bezitramide.

Butorphanol.

Chlorodyne (Chloroform and Morphine Tincture BP 1980) or any preparation or mixture thereof described as chlorodyne, except preparations and mixtures containing not more than 5,0 per cent of chlorodyne in combination with other active medicinal substances.

Clonitazene.

Coca leaf and any salt, compound, derivative or preparation of coca leaf, and any salt, compound, derivative or preparation thereof that is chemically equivalent or identical to any of these substances, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except decocainized coca leaf and extractions of coca leaf where such extractions contain no cocaine or ecgonine.

Codeine (methylmorphine), except preparations and mixtures containing not more than 20 milligrams of codeine per recommended or prescribed dose.

Codoxime.

Desomorphine.

Dextromoramide.

Dextropropoxyphene, except preparations and mixtures for oral use containing not more than 135 milligrams dextropropoxyphene, calculated as the base, per dosage unit, or with a concentration of not more than 2,5 per cent in undivided preparations.

Diampromide.

Diethylthiambutene.

Difenoxin (or diphenoxylic acid), except mixtures containing, per dosage unit, not more than 0,5 milligrams of difenoxin, calculated as the base, and a quantity of atropine sulphate equal

to at least 5,0 per cent of the quantity of difenoxin, calculated as the base, which is present in the mixture.

Dihydrocodeine, except preparations and mixtures containing not more than 20 milligrams of dihydrocodeine per recommended or prescribed dose.

Dihydromorphine.

Dimenoxadol.

Dimepheptanol.


Dioxaphetylbutyrate.

Diphenoxylate, except preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit.Dipipanone.

Dronabinol [(-)-transdelta-9-tetrahydrocannabinol].

Drotebanol.

Ecgonine and the esters and derivatives thereof which are convertible to ecgonine and cocaine.


Ethylmorphine, except preparations and mixtures containing not more than 20 milligrams of ethylmorphine per recommended or prescribed dose.

Etonitazene.

Etorphine.

Etoxeridine.

Fenproporex.

Fentanyl.

Furethidine.




Hydroxypethidine.

Isomethadone.

Ketobemidone.

Levomoramide.

Levophenacylmorphan.

Levorphanol.

Mecloqualone.

Mefenorex.

Metazocine.

Methadone.


Methorphan, including levomethorphan and racemethorphan, but excluding dextromethorphan.

Methyldesorphine.


Methylphenidate and the derivatives thereof.

Metopon.


Morpheridine.

Morphine, except preparations and mixtures of morphine containing not more than 0,2 per cent of morphine, calculated as anhydrous morphine.


Morphine-N-oxide and the derivatives thereof.

Myrophine (myristylbenzylmorphine).

Nicocodine.

Nicodicodine.

Nicomorphine.

Noracymethadol.

Norcodeine, except preparations and mixtures containing not more than 20 milligrams norcodeine per recommended or prescribed dose.

Norlevorphanol.

Normethadone.


Norpipanone.

Opium and opiates and any salt, compound, derivative or preparation of opium or opiates, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except mixtures containing not more than 0,2 per cent of morphine, calculated as anhydrous morphine.



Oxymorphone (14-hydroxydihydromophinone or dihydrohydroxymorphinone).

Pethidine, pethidine-intermediate A, pethidine-intermediate B and pethidine-intermediate C.

Phenadoxone.

Phenampromide.

Phenazocine.

Phendimetrazine.

Phenomorphan.

Phenoperidine.

Pholcodine, except preparations and mixtures containing not more than 20 milligrams of pholcodine per recommended or prescribed dose.

Piminodine.

Piritramide.

Proheptazine.

Properidine.

Propiram.

Racemoramide.

Racemorphan.

Secobarbital.

Sufentanil.

Thebacon.

Thebaine.

Tilidine.

Trimeperidine.

Zipeprol.


(a)




all preparations and mixtures of the specified substances or plants and of the isomers, esters, ethers and salts referred to in this paragraph.PART III

Undesirable Dependence-Producing Substances


Amphetamine.

Brolamfetamine.

4-bromo-2,5-dimethoxyphenethylamine (2C-B), (“Nexus”).


Cannibis (dagga), the whole plant or any portion thereof, except dronabinol [(-)-transdelta-9 tetrahydrocannabinol].

Cathinone.

Dexamphetamine.Diethyltryptamine [3-(2-(diethylamino)-ethyl)-indole;cb.

2,5-dimethoxyamphetamine (DMA).

2,5-dimethoxy-4-ethylamphetamine (DOET).

(±)-N,μ-dimethyl-3,4-(methylenedioxy) phenethylamine (3,4-methylenedioxymetamfetamine (MDMA).

3-(1,2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo [b, d] pyran-1-ol (DMHP).

Dimethyltryptamine [3-(2-(dimethylamino)-ethyl)-indole].

Etryptamine (3-(2-aminobutyl)indole).

Fenetylline.

Fentanyl-analogues:

acetyl-alpha-methyl-fentanyl;

alpha-methyl-fentanyl;

alpha-methyl-fentanyl-acetanilide;

alpha-methyl-thio-fentanyl;

benzyl-fentanyl;

beta-hydroxy-fentanyl;

beta-hydroxy-3-methyl-fentanyl;

3-methyl-fentanyl and the two isomeric forms thereof, namely,

cis-N-(3-methyl-1-(2-phenethyl)-4-piperidyl)propionanilide and trans-N-(3-methyl-1-(2-phenethyl)-4-piperidyl)propionanilide;

3-methyl-thio-fentanyl;

para-fluoro-fentanyl; and

thiofentanyl.



Herion (diacetylmorphine).

Levamphetamine.

Levomethamphetamine.

Lysergide (lysergic acid diethylamide).



Methaqualone, including Mandrax, Isonox, Quaalude, or any other preparation containing methaqualone and known by any other trade name.

Methcathinone (2-(methylamino)-1-phenylpropan-1-one).

2-methoxy-4,5-methylenedioxyamphetamine (MMDA).

4-methylaminorex.

4-methyl-2,5-dimethoxyamphetamine (DOM) and the derivatives thereof.

Methylenedioxyamphetamine (MDA):

N-ethyl-methylenedioxyamphetamine; and

N-hydroxy-methylenedioxyamphetamine.

Nabilone.

Parahexyl.

Paramethoxyamphetamine (PMA).

Phencyclidine and the congeners thereof, namely, N-ethyl-1-phenylcyclohexylamine (PCE), 1-(1-phenylcyclohexyl) pyrrolidine (PHP or PCPY) and 1- [1-(2-thienyl) cycohexyl] piperidine (TCP).

Pethidine-analogues:

1-methyl-4-phenyl-4-propionoxy-piperidine (MPPP);

1-methyl-4-phenyl-1,2,5,6-tetrahydropiperidine (MPTP); and

1-phenylethyl-4-phenyl-4-acetyloxy-piperidine (PEPAP).

Phenmetrazine.

Psilocin (4-hydroxydimethyltryptamine).

Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine).

Tetrahydrocannabinol.

3,4,5-trimethoxy amphetamine (TMA).


(a)




all preparations and mixtures of the specified substances or plants and of the isomers, esters, ethers and salts referred to in this paragraph.(Prior to amendment by Act No. 121 of 1998)

Section 1, definitions—“convert”, “defined crime”, “economic offence”, “financial institution” and “proceeds”

“convert”, in relation to property, includes—

(a)

any agreement or understanding in connection with the property, whether any such agreement or understanding is legally enforceable or not; or(b)

any other act in connection with the property, whether any such act is performed independently or in concert with other persons,which has or is likely to have the effect—

(i)of concealing or disguising the nature, source, location, disposition or movement of the property or its ownership or any interest with respect thereto; or(ii)of enabling or assisting any person who has committed or commits, whether in the Republic or elsewhere, a drug offence or an economic offence—(aa)

to avoid prosecution; or(bb)

to remove or to diminish any property, or any part thereof, realized directly or indirectly by him as a result of the commission of the said offence, or to use it in order to obtain funds, investments or other property;“defined crime” means—

(a)

a drug offence; or(b)

the conversion of property, or any part thereof, which was derived directly or indirectly as a result of the commission, whether in the Republic or elsewhere, of a drug offence;“economic offence”—

(a)

in relation to an economic offence committed in the Republic, means an offence referred to in section 14 (b);(b)

in relation to an economic offence committed outside the Republic, means any act or omission which, if it had occurred within the Republic, would have constituted an offence referred to in that section;“financial institution” means—

(a)

any public company registered provisionally or finally as a deposit-taking institution in terms of the Deposit-taking Institutions Act, 1990 (Act No. 94 of 1990);

(b)

the Land and Agricultural Bank of South Africa;(c)

the Development Bank of Southern Africa;(d)

a mutual building society as defined in section 1 (1) of the Mutual Building Societies Act, 1965 (Act No. 24 of 1965);(e)

an insurer registered in terms of the Insurance Act, 1943 (Act No. 27 of 1943), and carrying on any class of long-term insurance business, other than a funeral business, within the Republic;( f )

any company registered as a management company in terms of the Unit Trusts Control Act, 1981 (Act No. 54 of 1981), or any company or institution registered as a trustee in terms of that Act;“proceeds”, in relation to a defined crime, means any property, or any part thereof, which was derived directly or indirectly as a result of—

(a)

the commission in the Republic of the defined crime; or(b)

any act or omission outside the Republic which, if it had occurred in the Republic, would have constituted the defined crime;Repealed Act Act 24 of 1965 has been repealed by s 95 of Act 124 of 1993




Section 6

6. Acquisition of proceeds of defined crime.—No person shall acquire any property, knowing that such property is the proceeds of a defined crime.

Section 7

7. Conversion of proceeds of defined crime.—No person shall convert any property, while

he knows or has reasonable grounds to suspect that any such property is the proceeds of a defined crime.

Section 9 (1)

(1) Any person may, notwithstanding anything to the contrary contained in any law which prohibits him—

(a)

from disclosing any information relating to the affairs or business of any other person; or(b)from permitting any person to have access to any registers, records or other documents which have a bearing on the said affairs or business,disclose to any attorney-general or designated officer such information as he may consider necessary for the prevention or combating, whether in the Republic or elsewhere, of a drug offence or an economic offence, or permit any designated officer to have access to any registers, records or other documents which may in his opinion have a bearing on the latter information.

Section 10 (2)

(2) If any director, manager or executive officer of a financial institution has reason to suspect that any property acquired by the financial institution from any person in the ordinary course of the financial institution’s business is the proceeds of a defined crime, he shall—

(a)

as soon as possible report his suspicion to any designated officer; and(b)

at the request of that designated officer, furnish the said officer with such particulars as he may have available regarding any such person.(Prior to amendment by Government Notice No. R. 344 of 13 March 1998)

Schedule 1, Part I

PART I


Ephedrine.

Ergometrine.

Ergotamine.

Lysergic acid.

1-phenyl-2-propanone.

Pseudoephedrine.


Schedule 1, Part II

PART II

1. The following substances, namely—Acetic anhydride.

Acetone.

Anthranilic acid.

Ethyl ether.

Phenylacetic acid.

Piperidine.


(Prior to amendment by Act No. 75 of 1996)

Chapter VI

MUTUAL ASSISTANCE IN RESPECT OF DRUG TRAFFICKING

Application of chapter

54. Definitions.— In this Chapter, unless the context indicates otherwise—

“appropriate authority”, in relation to a designated country, means the appropriate authority of the designated country determined under section 55 (1) (b);

“certified copy”, in relation to a foreign confiscation order, means a copy of the foreign confiscation order certified to be a true copy by a person prescribed for that purpose;

“designated country” means a country designated under section 55 (1) (a);

“foreign confiscation order” means an order made by a court of a designated country with a view to recovering any payment or other reward received in connection with drug trafficking, or the value of any such payment or reward;

“lower court”, in relation to—

(a)

any person against whom a foreign confiscation order for the payment of money may be enforced, means the magistrate’s court of the district in which any such person—(i)resides, carries on business or is employed; or(ii)holds any movable or immovable property;(b)

any company or other juristic person against which the said foreign confiscation order may be enforced, means the magistrate’s court of the district in which the registered office or main place of business of any such company or juristic person is situate;(c)

any partnership against which the said foreign confiscation order may be enforced, means the magistrate’s court of the district in which any place of business of any such partnership is situate, or in which any member thereof resides; or(d)

any foreign confiscation order for the recovery of particular property, means the magistrate’s court of the district in which that property is to be found on the date of the registration of any such foreign confiscation order;“prescribed” means prescribed by regulation;

“regulation” means a regulation made under section 61 (1);

“this Chapter” includes a regulation,

and any other word or expression shall have the meaning assigned thereto in Chapter V.

55. Designated countries and appropriate authorities.—(1) For the purposes of this Chapter, the Minister may by notice in the Gazette—

(a)

designate any country outside the Republic as a designated country; and(b)

determine the appropriate authority of any such country.(2) The Minister may at any time amend or withdraw a notice referred to in subsection (1) by like notice in the Gazette.

Foreign confiscation orders

56. Registration of foreign confiscation orders.—(1) Whenever a certified copy of a foreign confiscation order is lodged with a clerk of a lower court in the Republic, that clerk shall register the foreign confiscation order in the prescribed manner—

(a)

where the foreign confiscation order was made for the payment of money, in respect of the balance of the amount payable thereunder; or(b)

where the foreign confiscation order was made for the recovery of particular property, in respect of the property which is specified therein.(2) The clerk of the lower court registering a foreign confiscation order shall forthwith issue a notice addressed to any person against whom the foreign confiscation order may be enforced and stating—

(a)

that the foreign confiscation order has been registered at the lower court concerned; and(b)

that any such person may within the prescribed period apply to that lower court for the setting aside of the registration of the foreign confiscation order,and such notice shall be served on any such person in the prescribed manner.

(3) If any amount payable under a foreign confiscation order registered in terms of this section is expressed in a currency other than the currency of the Republic, that amount shall be converted into the currency of the Republic on the basis of the exchange rate prevailing on the date of registration of the foreign confiscation order.

57. Effect of registration, and execution of foreign confiscation orders.—(1) Whenever any foreign confiscation order has been registered in terms of section 56, that foreign confiscation order shall have the effect of a civil judgment of the lower court at which it has been registered.

(2) Notwithstanding the provisions of subsection (1), no foreign confiscation order registered in terms of section 56 shall be executed—

(a)

before the expiry of the period contemplated in section 56 (2) (b); or(b)

if an application for the setting aside of the registration of the foreign confiscation order has been made within that period, until a final decision has been rendered in respect of any such application.58. Setting aside of registration of foreign confiscation orders.—(1) The registration of a foreign confiscation order in terms of section 56 shall, on the application of any person against whom the foreign confiscation order may be enforced, be set aside if the lower court at which it was registered is satisfied—

(a)

that the foreign confiscation order was registered in contravention of a provision of this Chapter;

(b)

that the court of the designated country concerned had no jurisdiction in the circumstances of the case;(c)

that the foreign confiscation order is subject to review or appeal;(d)where the person against whom the foreign confiscation order was made did not appear at the proceedings in which it was made, that such person did not receive notice of the said proceedings as prescribed by the law of the designated country concerned or, if no such notice is so prescribed, that he did not receive reasonable notice of those proceedings to enable him to defend the proceedings;(e)

that the enforcement of the foreign confiscation order would be contrary to the interests of justice;( f )

that the foreign confiscation order has been satisfied in any manner, including the serving of imprisonment in default of payment.(2) The lower court hearing an application referred to in subsection (1) may at any time postpone the hearing of the application to such date as it may determine.

Satisfaction of confiscation orders

59. Satisfaction of confiscation orders in designated countries.—Where—

(a)

the attorney-general concerned has addressed a request to the appropriate authority of a designated country for assistance in enforcing a confiscation order; and(b)

in the execution of such request, an amount is paid, or property is recovered, in the said country,the amount payable under the confiscation order shall be deemed to have been reduced by the amount so paid or by the value of the property so recovered, as the case may be.

60. Conversion of currencies.—(1) If any amount paid in a designated country in the execution of a request referred to in section 59 (a) is expressed in a currency other than the currency of the Republic, that amount shall be converted into the currency of the Republic on the basis of the exchange rate prevailing on the date on which that amount was paid in that designated country.

(2) If the value of property recovered in a designated country in the execution of a request referred to in section 59 (a) is expressed in a currency other than the currency of the Republic, that value shall be converted into the currency of the Republic on the basis of the exchange rate prevailing on the date on which the property was recovered in that designated country.

Regulations

61. Regulations.—(1) The Minister may make regulations—

(a)

providing for the application, to the extent stated in the regulations, of the provisions of Chapter V to any foreign confiscation order or to proceedings which have been or are to be instituted in a designated country and may result in a foreign confiscation order being made in that designated country;(b)

providing for any matter relating to the taking of action in a designated country with a view to satisfying a confiscation order;(c)

as to evidence or proof of any matter for the purposes of this Chapter;(d)

as to any matter required or permitted to be prescribed under this Chapter by regulation;(e)

in general, as to any matter which the Minister may consider necessary or expedient to prescribe or regulate in order that the objects of this Chapter may be achieved.(2) The power conferred upon the Minister by subsection (1) (a) shall include the power—

(a)

to amend or adapt Chapter V in order to regulate its application; and(b)

to confer any discretionary power upon any court or person.(3) Different regulations may be made under subsection (1) in respect of different designated countries.

62. Tabling of regulations.—(1) A copy of a regulation shall be laid upon the Table in Parliament by the Minister within 14 days after the publication thereof if Parliament is then in session or, if Parliament is then not in session, within 14 days after the commencement of its next ensuing session.

(2) If Parliament disapproves of such regulation or any provision thereof, such regulation or provision shall cease to be of force and effect to the extent to which it is so disapproved.

(3) The provisions of subsection (2) shall not derogate from the validity of anything done under such regulation or provision before the date upon which it so ceased to be of force and effect, or from any right, privilege, obligation or liability acquired, accrued or incurred at the said date in terms of or by virtue of such regulation or provision.

Section 65

65. Rules of court.—The powers conferred upon the Rules Board for Courts of Law by section 6 of the Rules Board for Courts of Law Act, 1985 (Act No. 107 of 1985), shall include the power to make rules not inconsistent with a provision of this Act or a regulation made under section 61 (1) as to any matter which that Rules Board may consider necessary or expedient to prescribe or regulate in order that the objects of Chapters V and VI may be achieved.(Prior to amendment by Act No. 76 of 1996)

Chapter V

CHAPTER V

PROCEEDS OF DRUG TRAFFICKING

Application of chapter

28. Definitions.—(1) In this Chapter, unless the context indicates otherwise—

“affected gift” means any gift—

(a)

made by the defendant in question not more than five years before the fixed date; or(b)

made by the defendant in question at any time, if it was a gift—(i)of property received by that defendant in connection with drug trafficking carried on by him or any other person; or(ii)of property, or any part thereof, which directly or indirectly represented in that defendant’s hands property received by him in that connection,whether any such gift was made before or after the commencement of this Act;

“confiscation order” means an order referred to in section 35 (1);

“defendant” means a person against whom a prosecution for an offence referred to in section 13 ( f ) or 14 (b) has been instituted, irrespective of whether he has been convicted or not, and includes a person referred to in section 41 (1) (b);

“drug trafficking” includes—

(a)

any act in the Republic which constitutes a drug offence or an economic offence; or(b)

any act or omission outside the Republic which, if it had occurred in the Republic, would have constituted a drug offence or an economic offence,

or to be concerned in any such act or omission;

“fixed date”, in relation to a defendant—

(a)

if a prosecution for an offence referred to in section 13 ( f ) or 14 (b) has been instituted against the defendant, means the date on which such prosecution has been instituted; or(b)

if a restraint order has been or is being made against the defendant, means the date of such restraint order,whichever is the earlier date;

“restraint order” means an order referred to in section 42 (1);

“superior court” means a provincial or local division of the Supreme Court of South Africa, and includes, for the purposes of sections 41 to 45, any judge thereof.

(2) In this Chapter, except where it is inconsistent with the context or clearly in appropriate, any reference—

(a)

to a person who holds property shall be construed as a reference to a person who has any interest in the property, and(i)if the estate of such person has been sequestrated, also to the executor of his insolvent estate; or(ii)if such person is a company or other juristic person which is being wound up, also to the liquidator thereof;(b)

to a person who transfers property to any other person shall be construed as a reference to a person who transfers or grants to any other person any interest in the property;(c)

to anything received in connection with drug trafficking shall be construed as a reference also to anything received both in that connection and in some other connection.29. Persons who have benefited from drug trafficking.—For the purposes of this Chapter, a person has benefited from drug trafficking if he has at any time, whether before or after the commencement of this Act, received any payment or other reward in connection with drug trafficking carried on by him or any other person.

30. Proceeds of drug trafficking.—For the purposes of this Chapter, any payment or other reward received by a defendant at any time, whether before or after the commencement of this Act, in connection with drug trafficking carried on by him or any other person shall be his proceeds of drug trafficking.

31. Realizable property.—(1) Subject to the provisions of subsection (2), the following property shall be realizable in terms of the provisions of this Chapter, namely—

(a)

any property held by the defendant in question; and(b)

any property held by a person to whom that defendant has directly or indirectly made any affected gift.(2) Property shall not be realizable property if a declaration of forfeiture is in force in respect of the property.

32. Value of property.—(1) For the purposes of this Chapter, the value of property, excluding any money, in relation to any person holding the property—

(a)

where any other person holds an interest in the property, shall be—(i)the market value of the property; less(ii)the amount required to discharge any encumbrance on the property; and(b)

where no other person holds an interest in the property, the market value of the property.(2) Notwithstanding the provisions of subsection (1), any reference in this Chapter to the value at a particular time of a payment or reward, shall be construed as a reference to—

(a)

the value of the payment or reward at the time when the recipient received it as adjusted to take into account subsequent fluctuations in the value of money; or(b)

where subsection (3) applies, the value mentioned in that subsection, whichever is the greater value.(3) If at the particular time the recipient holds—

(a)

the property, other than cash, which he received, the value in question shall be the value of the property at the particular time; or(b)

property, or any part thereof, which directly or indirectly represents in his hands the property which he received, the value in question shall be the value of the property, in so far as it represents the property which he received, at the relevant time.33. Gifts.—(1) For the purposes of this Chapter, a defendant shall be deemed to have made a gift if he has transferred any property to any other person directly or indirectly for a

consideration the value of which is significantly less than the value of the consideration supplied by the defendant.

(2) For the purposes of section 37 (2), such a defendant shall be deemed to have made a gift of that share in the property which bears to the property as a whole the same proportion as the difference between the values referred to in subsection (1) bears to the value of the consideration supplied by that defendant.

34. Conclusion of proceedings against defendant.—For the purposes of this Chapter, the proceedings against a defendant shall be concluded when—

(a)

the defendant is acquitted or found not guilty of an offence referred to in section 13 ( f ) or 14 (b);(b)

the court convicting the defendant of such an offence, sentences the defendant without making a confiscation order against him;(c)

the conviction in respect of such an offence is set aside on review or appeal; or(d)

the defendant satisfies the confiscation order made against him.Confiscation orders

35. Confiscation orders.—(1) Whenever a defendant is convicted of an offence referred to in section 13 ( f ) or 14 (b), the court convicting the defendant may, on the application of the public prosecutor, enquire into any benefit which the defendant may have derived from the drug trafficking and, if that court finds that the defendant has benefited from drug trafficking, that court may, in addition to any punishment which that court may impose in respect of the offence, make an order against the defendant for the payment to the State of such amount as that court may consider appropriate, which amount—

(a)

shall not exceed the value of the defendant’s proceeds of drug trafficking as determined by that court in accordance with the provisions of this Chapter; or(b)

if that court is satisfied that the amount which might be realized as contemplated in section 37 (1) is less than the value referred to in paragraph (a), shall not exceed an amount which in the opinion of that court might be so realized.(2) No application referred to in subsection (1) shall be made without the written authority of the attorney-general concerned.

(3) A court before which proceedings under this section are pending, may—

(a)

in order to make a confiscation order—(i)refer to the evidence and proceedings at the trial;(ii)hear such further oral evidence as the court may deem fit;(iii)direct the public prosecutor to tender to the court a statement referred to in subsection (1) (a) of section 38; or(iv)direct a defendant to tender to the court a statement referred to in subsection (3) (a) of that section;(b)

subject to subsection (1) (b) or subsection (3) (b) of the said section, adjourn such proceedings to any day on such conditions not inconsistent with a provision of the Criminal Procedure Act, 1977 (Act No. 51 of 1977), and as the court may deem fit.(4) Notwithstanding anything to the contrary in this section contained, the court which made a confiscation order shall take the confiscation order into account in determining the fine which it may impose in respect of the offence in question.

36. Value of proceeds of drug trafficking.—(1) Subject to the provisions of subsection (2), the value of a defendant’s proceeds of drug trafficking shall be the sum of the values of the payments or other rewards received by him at any time, whether before or after the commencement of this Act, in connection with drug trafficking carried on by him or any other person.

(2) In determining the value of a defendant’s proceeds of drug trafficking, the court shall—

(a)

where the court has made a declaration of forfeiture or where a declaration of forfeiture has previously been made in respect of property which is proved to the satisfaction of the court—(i)to have been the property which the defendant received in connection with drug trafficking carried on by him or any other person; or(ii)to have been property, or any part thereof, which directly or indirectly represented in the defendant’s hands the property which he received in that connection,leave the property out of account;

(b)

where a confiscation order has previously been made against the defendant, leave out of account those proceeds of drug trafficking which are proved to the satisfaction of the court to have been taken into account in determining the amount to be recovered under that confiscation order.37. Amounts which might be realized.—(1) For the purposes of section 35 (1) (b) or 38 (3) (a), the amount which might be realized at the time of the making of a confiscation order against a defendant shall be the amount equal to—

(a)the sum of—(i)the values at that time of all realizable property held by the defendant; and(ii)the values at that time of all affected gifts made by the defendant; less (b)

if there are obligations having priority at that time, the sum of all amounts payable in pursuance of such obligations.(2) Notwithstanding the provisions of section 32 (1) but subject to the provisions of section 33 (2), the value of an affected gift at the time of the making of the relevant confiscation order shall be—

(a)

the value of the affected gift at the time when the recipient received it as adjusted to take into account subsequent fluctuations in the value of money; or(b)

where subsection (3) applies, the value mentioned in that subsection,whichever is the greater value.

(3) If at the time of the making of the relevant confiscation order the recipient holds—

(a)

the property, other than cash, which he received, the value in question shall be the value of the property at that time; or(b)

property, or any part thereof, which directly or indirectly represents in his hands the property which he received, the value in question shall be the value of the property, in so far as it represents the property which he received, at the time.(4) For the purposes of subsection (1), an obligation has priority at the time in question—

(a)

if it is an obligation of the defendant, where he has been convicted by a court of any offence—(i)to pay a fine imposed before that time by the court; or(ii)to pay any other amount under any resultant order made before that time by the court;(b)

if it is an obligation which—(i)if the estate of the defendant had at that time been sequestrated; or

(ii)where the defendant is a company or other juristic person, if such company or juristic person is at that time being wound up,would be payable in pursuance of any secured or preferent claim against the insolvent estate or against such company or juristic person, as the case may be.

38. Statements relating to drug trafficking.—(1) (a) The public prosecutor may or, if so directed by the court, shall tender to the court a statement in writing under oath or affirmation by him or any other person in connection with any matter which is being enquired into by the court under section 35 (1), or which relates to the determination of the value of a defendant’s proceeds of drug trafficking.

(b) A copy of such statement shall be served on the defendant at least 14 days before the date on which that statement is to be tendered to the court.

(2) (a) The court may afford a defendant an opportunity to dispute the correctness of any allegation contained in a statement referred to in subsection (1) (a), and the defendant shall, if he disputes the correctness of any such allegation, state the grounds on which he relies.

(b) In so far as the defendant does not dispute the correctness of any allegation contained in such statement, that allegation shall be deemed to be conclusive proof of the matter to which it relates.

(3) (a) A defendant may or, if so directed by the court, shall tender to the court a statement in writing under oath or affirmation by him or any other person in connection with any matter which relates to the determination of the amount which might be realized as contemplated in section 37 (1).

(b) A copy of such statement shall be served on the public prosecutor at least 14 days before the date on which that statement is to be tendered to the court.

(4) (a) The court may afford the public prosecutor an opportunity to admit the correctness of any allegation contained in a statement referred to in subsection (3) (a).

(b) In so far as the public prosecutor admits the correctness of any allegation contained in such statement, that allegation shall be deemed to be conclusive proof of the matter to which it relates.

(5) No express or implied acceptance by a defendant by virtue of this section that any payment or other reward was received by him in connection with drug trafficking carried on by him or any other person shall be admissible as evidence at any proceedings in respect of an offence.

39. Presumptions relating to proceeds of drug trafficking.—(1) For the purposes of an enquiry under section 35 (1) and, if it is found that a defendant has benefited from drug trafficking, in determining the value of his proceeds of drug trafficking, it shall be presumed, in the absence of evidence to the contrary—

(a)

that any property—(i)held by him at any time since his conviction; or(ii)transferred to him at any time since the beginning of a period of five years before the fixed date,was received by him, at the earliest time at which he held it, as a payment or other reward in connection with drug trafficking carried on by him;

(b)

that any expenditure incurred by him since the beginning of the period contemplated in paragraph (a) was met out of payments received by him in connection with drug trafficking carried on by him; and(c)

that, for the purpose of determining the value of any property—(i)received by him at any time as a reward in connection with drug trafficking carried on by him or any other person; or(ii)presumed in terms of paragraph (a) to have been received by him as a reward in connection with drug trafficking carried on by him,he received that property free of any other interest therein.

(2) Subsection (1) shall not apply in respect of a defendant who has been convicted of an offence referred to in section 14 (b) only.

40. Effect of confiscation orders.—(1) A confiscation order made—

(a)

by a magistrate’s court, other than a regional court, shall have the effect of a civil judgment of that court;(b)

by a regional court shall have the effect of a civil judgment of the magistrate’s court of the district in which the relevant trial took place.(2) Where a superior court makes a confiscation order—

(a)

the confiscation order shall have the effect of a civil judgment of that court; or(b)

the presiding judge may direct the registrar of that court to forward a certified copy of the confiscation order to the clerk of the magistrate’s court designated by the presiding judge or, if no such court is designated, to the clerk of the magistrate’s court within the area of jurisdiction of which the offence in question was committed, and, on receipt of the said copy of the confiscation order by the clerk of the magistrate’s court concerned, the confiscation

order shall have the effect of a civil judgment of that magistrate’s court.Restraint orders

41. Cases in which restraint orders may be made.—(1) A superior court may exercise the powers conferred upon it by section 42 (1)—

(a)

whenever—(i)a prosecution for an offence referred to in section 13 ( f ) or 14 (b) has been instituted against the defendant in question;(ii)either a confiscation order has been made against that defendant or it appears to the court that there are reasonable grounds for believing that a confiscation order may be made against that defendant; and(iii)the proceeding against that defendant have not been concluded; or(b)

whenever—(i)that court is satisfied that a person is to be charged with an offence referred to in section 13 ( f ) or 14 (b); and(ii)it appears to that court that there are reasonable grounds for believing that a confiscation order may be made against such person.(2) Where a superior court has made a restraint order by virtue of the provisions of subsection (1) (b), that court shall rescind the restraint order if the relevant person is not charged within such period as the court may consider reasonable.

42. Restraint orders.—(1) The attorney-general concerned, or any public prosecutor authorized thereto in writing by him, may by way of an ex parte application apply to a competent superior court for an order prohibiting any person, subject to such conditions and exceptions as may be specified in the order, from dealing in any manner with any property to which the order relates.

(2) A restraint order may be made—

(a)

in respect of such realizable property as may be specified in the restraint order and which is held by the person against whom the restraint order is being made;(b)

in respect of all realizable property held by such person, whether it is specified in the restraint order or not; and(c)

in respect of all property which, if it is transferred to such person after the making of the

restraint order, would be realizable property.(3) (a) A restraint order shall provide for notice to be given to persons affected by the order.

(b) Any person affected by a restraint order may at any time apply for the variation or rescission of the order.

(4) The superior court which made a restraint order—

(a)

may at any time vary or rescind the restraint order; or(b)

shall rescind the restraint order if the proceedings against the defendant in question are concluded.(5) Without derogating from the generality of the powers conferred by subsection (1), a restraint order may make such provision as the superior court thinks fit—

(a)

for the reasonable living expenses of a person against whom the restraint order is being made and his family or household; and(b)

for the reasonable legal expenses of such person in connection with any proceedings instituted against him in terms of this Act.43. Seizure of property subject to restraint order.—(1) In order to prevent any realizable property from being disposed of or removed contrary to a restraint order, any police officer may seize any such property.

(2) Property seized under subsection (1) shall be dealt with in accordance with the directions of the superior court which made the relevant restraint order.

44. Appointment of curator bonis in respect of property subject to restraint order.— (1) Where a superior court has made a restraint order, that court may at any time—

(a)

appoint a curator bonis to do, subject to the directions of that court, any one or more of the following on behalf of the person against whom the restraint order has been made, namely—(i)to perform any particular act in respect of any of or all the property to which the restraint order relates;(ii)to take care of the said property;(iii)to administer the said property; and(iv)where the said property is a business or undertaking, to carry on, with due regard to any law which may be applicable, the business or undertaking;

(b)

order the person against whom the restraint order has been made to surrender forthwith, or within such period as that court may determine, any property in respect of which a curator bonis has been appointed under paragraph (a), into the custody of that curator bonis.(2) Any person affected by an order contemplated in subsection (1) (b) may at any time apply—

(a)

for the variation or rescission of the order; and(b)

for the variation of the terms of the appointment of the curator bonis concerned or for the discharge of that curator bonis.(3) The superior court which made an order contemplated in subsection (1) (b)—

(a)

may at any time—(i)vary or rescind the order; or(ii)vary the terms of the appointment of the curator bonis concerned or discharge that curator bonis; or(b)

shall rescind the order and discharge the curator bonis concerned if the relevant restraint order is rescinded.45. Orders in respect of immovable property subject to restraint order.—(1) A superior court which has made a restraint order in respect of immovable property may at any time, with a view to ensuring the payment to the State—

(a)

where a confiscation order has not been made, of an amount equal to the most recent value of the immovable property; or(b)

where a confiscation order has been made, of an amount not exceeding the amount payable under the confiscation order,order the registrar of deeds concerned to endorse any one or more of the restrictions contemplated in subsection (2) on the title deed of the immovable property.

(2) An order contemplated in subsection (1) may be made in respect of the following restrictions, namely—

(a)that the immovable property shall not without the consent of the superior court be mortgaged or otherwise encumbered;

(b)

that the immovable property shall not without the consent of the superior court be attached or sold in execution; and(c)

that the immovable property shall not without the consent of the superior court—(i)vest in the Master of the Supreme Court or trustee concerned, as the case may be, when the estate of the owner of that immovable property is sequestrated; or(ii)where the owner of that immovable property is a company or other juristic person which is being wound up, form part of the assets of such company or juristic person,if the owner of that immovable property has not made the payment referred to in that subsection to the State.

(3) In order to give effect to subsection (1), the registrar of deeds concerned shall—

(a)

make the necessary entries in his registers and the necessary endorsement on the office copy of the title deed, and thereupon any such restriction shall be effective against all persons except, in the case of a restriction contemplated in paragraph (b) of subsection (2), against any person in whose favour a mortgage bond or other charge was registered against the title deed of immovable property prior to the endorsement of the restriction on the title deed of the immovable property, but shall lapse on the transfer of ownership of the immovable property in question;(b)

when the original of the title deed is produced to him, make the necessary endorsement thereon.(4) Unless the superior court directs otherwise, the custody of immovable property on the title deed of which a restriction contemplated in paragraph (c) of subsection (2) was endorsed shall vest as from the date on which—

(a)

the estate of the owner of the immovable property is sequestrated; or(b)

where the owner of the immovable property is a company or other juristic person, such company or juristic person is being wound up,in the person in whom the said custody would have vested if such a restriction were not so endorsed.

(5) Where the superior court granted its consent in respect of a restriction contemplated in paragraph (c) of subsection (2) and endorsed on the title deed of immovable property, the immovable property shall be deemed—

(a)

if the estate of the owner of the immovable property was sequestrated, to have vested in the Master of the Supreme Court or trustee concerned, as the case may be, as if such a restriction were not so endorsed; or(b)

if the owner of the immovable property is a company or other juristic person which is being wound up, to have formed part of the assets of such company or juristic person as if such a restriction were not so endorsed.(6) Any person affected by an order contemplated in subsection (1) may at any time apply for the rescission of the order.

(7) (a) The superior court which made an order contemplated in subsection (1)—

(i)may at any time rescind the order; or(ii)shall rescind the order if the relevant restraint order is rescinded or the amount payment of which is ensured by the order has with the consent of that court been paid into court.(b) If such order is rescinded, the superior court shall direct the registrar of deeds concerned to cancel any restriction endorsed by virtue of that order on the title deed of immovable property, and that registrar of deeds shall give effect to any such direction.

Realization of property

46. Realization of property.—(1) A superior court may exercise the powers conferred upon it by subsection (2) whenever—

(a)

a confiscation order has been made against the defendant in question;(b)

such confiscation order is no longer subject to review or appeal; and(c)

the proceedings against that defendant have not been concluded.(2) A competent superior court may, on the application of the attorney-general concerned or any public prosecutor authorized thereto in writing by that attorney-general—

(a)

if a curator bonis has not been appointed in respect of any of the property in question, appoint a curator bonis in respect of realizable property;(b)

subject to subsection (3), authorize a curator bonis appointed under paragraph (a) of section 44 (1) or under paragraph (a) of this subsection, as the case may be, to realize any realizable property in such manner as that court may determine;(c)

order any person who holds realizable property to surrender the said property forthwith into the custody of a curator bonis appointed under paragraph (a) of section 44 (1) or under paragraph (a) of this subsection, as the case may be.(3) A superior court shall not exercise its powers under subsection (2) (b) unless it has afforded all persons having any interest in the property in question an opportunity to make representations to it in connection with the realization of that property.

47. Application of certain sums of money.—The following sums of money in the hands of a curator bonis appointed under this Chapter, namely—

(a)

the proceeds of any realizable property realized by virtue of section 46; and(b)

any other sums of money, being property held by the defendant in question,shall, after such payments as the superior court may direct have been made out of such sums of money, be applied on that defendant’s behalf in satisfaction of the confiscation order made against him: Provided that, if sums of money remain in the hands of the curator bonis after the amount payable under such confiscation order has been fully paid, the curator bonis shall distribute those sums of money—

(i)among such persons who held realizable property which has been realized by virtue of section 46; and(ii)in such proportions,as that court may, after affording such persons an opportunity to make representations to it in connection with the distribution of those sums of money, direct.

General

48. Functions of curator bonis.—(1) Immediately after letters of curatorship have been granted to a curator bonis appointed under this Chapter, the curator bonis shall take into his custody all the property in respect of which he was appointed, as well as any book, record or other document in the possession or custody or under the control of any person referred to in section 44 (1) (b) or 46 (2) (c) which relates to the said property.

(2) Save as is otherwise provided in this Chapter, the provisions of the Administration of Estates Act, 1965 (Act No. 66 of 1965), shall mutatis mutandis apply in respect of a curator bonis appointed under this Chapter.

49. Exercise of powers by superior court and curator bonis.—(1) The powers conferred upon a superior court by sections 42 to 47, or upon a curator bonis appointed under this Chapter, shall—

(a)

subject to paragraphs (b) and (c), be exercised with a view to making available for satisfying

any confiscation order which has been made against the defendant in question or which may be made against that defendant, as the case may be, the value for the time being of realizable property held by any person by the realization of such property;(b)

in the case of realizable property held by a person to whom that defendant has directly or indirectly made an affected gift, be exercised with a view to realizing no more than the value for the time being of such gift;(c)

be exercised with a view to allowing any person other than that defendant or the recipient of such gift to retain or recover the value of any property held by him,and, except as provided in sections 37 (1) and 42 (5), any obligation of that defendant or the recipient of such gift which conflicts with the obligation to satisfy a confiscation order shall be left out of account.

(2) The provisions of subsection (1) shall not be construed as prohibiting any superior court from making any additional order in respect of a debt owed to the State.

50. Variation of confiscation orders.—(1) If the superior court is satisfied that the realizable property is inadequate for the payment of the balance of the amount to be recovered under a confiscation order against the defendant in question, that court may, on the application of that defendant, issue a certificate to that effect stating the reasons for that court being so satisfied.

(2) For the purposes of subsection (1), the superior court may—

(a)

in the case of realizable property held—(i)by a person whose estate has been sequestrated, take into account the extent to which the proceeds of property in that estate may be distributed among the creditors; or(ii)by a company or other juristic person which is being wound up, take into account the extent to which the assets of such company or juristic person may be distributed among the creditors;(b)

leave out of account any inadequacy in the realizable property which is in the opinion of that court wholly or partly attributable to anything done by the defendant for the purpose of preserving any property held by a person to whom the defendant had directly or indirectly made an affected gift from the risk of any realization under this Chapter.(3) (a) If a certificate referred to in subsection (1) has been issued, the defendant may apply to the court which made the confiscation order against him for the reduction of the amount to be recovered under that confiscation order.(b) Such court or, if the judge or judicial officer concerned is not available, any judge or judicial officer of that court may substitute for the amount to be recovered under such confiscation order such lesser amount as that court may consider just in the circumstances of the case.

51. Effect of sequestration of estates on realizable property.—(1) When the estate of a person who holds realizable property is sequestrated—

(a)

no property for the time being subject to a restraint order made before the date of sequestration; and(b)

no proceeds of any realizable property realized by virtue of section 46 and for the time being in the hands of a curator bonis appointed under this Chapter,shall vest in the Master of the Supreme Court or trustee concerned, as the case may be.

(2) When the estate of a defendant who has directly or indirectly made an affected gift to any other person is sequestrated—

(a)

no court shall set aside the disposition of such gift under section 29, 30 or 31 of the Insolvency Act, 1936 (Act No. 24 of 1936)—(i)if a prosecution for an offence referred to in section 13 ( f ) or 14 (b) has been instituted against the defendant and the proceedings against him have not been concluded; or(ii)if the property of such person is subject to a restraint order;(b)

any court which sets aside any disposition contemplated in paragraph (a) after the conclusion of the proceedings against the defendant, shall take into account any realization of the property of such other person under this Chapter.(3) Where the estate of an insolvent has been sequestrated, the powers conferred upon a superior court by sections 42 to 47 and 49 (2), or upon a curator bonis appointed under this Chapter, shall not be exercised—

(a)

in respect of any property which forms part of that estate; or(b)

in respect of any property which the trustee concerned is entitled to claim from the insolvent under section 23 of the Insolvency Act, 1936.(4) Nothing in the Insolvency Act, 1936, shall be construed as prohibiting any superior court or curator bonis appointed under this Chapter from exercising any power contemplated in subsection (3) in respect of any property or proceeds mentioned in subsection (1).52. Effect of winding-up of companies or other juristic persons on realizable property.—(1) When any competent court has made an order for the winding-up of any company or other juristic person which holds realizable property or a resolution for the voluntary winding-up of any such company or juristic person has been registered in terms of any applicable law—

(a)

no property for the time being subject to a restraint order made before the relevant time; and(b)

no proceeds of any realizable property realized by virtue of section 46 and for the time being in the hands of a curator bonis appointed under this Chapter,shall form part of the assets of any such company or juristic person.

(2) Where an order mentioned in subsection (1) has been made in respect of a company or other juristic person or a resolution mentioned in that subsection has been registered in respect of such company or juristic person, the powers conferred upon a superior court by sections 42 to 47 and 49 (2), or upon a curator bonis appointed under this Chapter, shall not be exercised in respect of any property which forms part of the assets of such company or juristic person.

(3) Nothing in the Companies Act, 1973 (Act No. 61 of 1973), or any other law relating to juristic persons in general or any particular juristic person, shall be construed as prohibiting any superior court or curator bonis appointed under this Chapter from exercising any power contemplated in subsection (2) in respect of any property or proceeds mentioned in subsection (1).

(4) For the purposes of subsection (1), “the relevant time” means—

(a)

where an order for the winding-up of the company or juristic person, as the case may be, has been made, the time of the presentation to the court concerned of the application for the winding-up; or(b)

where no such order has been made, the time of the registration of the resolution authorizing the voluntary winding-up of the company or juristic person, as the case may be.53. Compensation.—(1) If a prosecution for an offence referred to in section 13 ( f ) or 14 (b) has been instituted against a defendant and either—

(a)

the prosecution does not result in a conviction of such an offence; or(b)

the conviction in respect of such an offence is set aside on review or appeal,any superior court may, on application of any person who held property which was realizable property, order the State to pay compensation to the applicant if, having regard to the circumstances of the case, that court considers it appropriate to make such an order.(2) A superior court shall not make an order contemplated in subsection (1) unless that court is satisfied—

(a)

that there has been some serious default on the part of any police official or public prosecutor

concerned in the investigation or prosecution of the offence; and(b)

that, but for such default, the prosecution would not have been instituted or continued; and(c)

that the applicant has suffered substantial loss or damage in consequence of anything done in respect of the property under sections 42 to 47 and 49 (2).(3) The amount to be paid as compensation in terms of this section shall be such amount as the superior court may consider just in the circumstances of the case.


Section 64 (b)

(b)

to make any order referred to in section 35 (1), even though the amount payable under that order may exceed the civil jurisdiction of a magistrate’s court.(Prior to amendment by Act No. 18 of 1996)

Section 4 (iii)

(iii)he is the Director-General: National Health and Population Development who has acquired or bought any such substance in accordance with the requirements of the Medicines Act or any regulation made thereunder;Section 5 (ii)

(ii)he is the Director-General: National Health and Population Development who acquires, buys or sells any such substance in accordance with the requirements of the Medicines Act or any regulation made thereunder;Section 8

8. Designated officers.—For the purposes of this Chapter, every commissioned officer of the South African Police assigned to the South African Narcotics Bureau shall be a designated officer.

MEDICINES AND RELATED SUBSTANCES ACTNO. 101 OF 1965

[View Regulation]

[ASSENTED TO 19 JUNE, 1965][DATE OF COMMENCEMENT: 1 APRIL, 1966]

(Afrikaans text signed by the State President)

This Act has been updated to Government Gazette 32838 dated 31 December, 2009.

as amended by

Drugs Control Amendment Act, No. 29 of 1968


Drugs Laws Amendment Act, No. 95 of 1971


Medicines and Related Substances Control Amendment Act, No. 19 of 1976

Health Laws Amendment Act, No. 36 of 1977



Transfer of Powers and Duties of the State President Act, No. 97 of 1986

[with effect from 3 October, 1986]

Businesses Act, No. 71 of 1991

[with effect from 24 May, 1991]


General Law Amendment Act, No. 49 of 1996

[with effect from 4 October, 1996]

Abolition of Restrictions on the Jurisdiction of Courts Act, No. 88 of 1996

[with effect from 22 November, 1996]


Medicines and Related Substances Amendment Act, No. 59 of 2002

Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003

Government Notice No. 491 in Government Gazette 31010 of 25 April, 2008

Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008

Judicial Matters Amendment Act, No. 66 of 2008

[with effect from 17 February, 2009]

Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009

proposed amendments by

Medicines and Related Substances Amendment Act, No. 72 of 2008(provisions not yet proclaimed) Proposed amendment by Section to be amended S. 1 of Act No. 72 of 2008 S. 1 of Act No. 101 of 1965 S. 2 of Act No. 72 of 2008 S. 2 of Act No. 101 of 1965 S. 3 of Act No. 72 of 2008 S. 3 of Act No. 101 of 1965 S. 4 of Act No. 72 of 2008 S. 4 of Act No. 101 of 1965 S. 5 of Act No. 72 of 2008 Ss. 5, 6, 7, 8, 9 and 12 of Act No. 101 of 1965 S. 6 of Act No. 72 of 2008 S. 13 of Act No. 101 of 1965 S. 7 of Act No. 72 of 2008 S. 14 of Act No. 101 of 1965 S. 8 of Act No. 72 of 2008 S. 15 of Act No. 101 of 1965 S. 9 of Act No. 72 of 2008 S. 15A of Act No. 101 of 1965 S. 10 of Act No. 72 of 2008 S. 15B of Act No. 101 of 1965 S. 11 of Act No. 72 of 2008

S. 15C of Act No. 101 of 1965 S. 12 of Act No. 72 of 2008 S. 16 of Act No. 101 of 1965 S. 13 of Act No. 72 of 2008 S. 17 of Act No. 101 of 1965 S. 14 of Act No. 72 of 2008 S. 18 of Act No. 101 of 1965 S. 15 of Act No. 72 of 2008 S. 18A of Act No. 101 of 1965 S. 16 of Act No. 72 of 2008 S. 18B of Act No. 101 of 1965 S. 17 of Act No. 72 of 2008 S. 18C of Act No. 101 of 1965 S. 18 of Act No. 72 of 2008 S. 19 of Act No. 101 of 1965 S. 19 of Act No. 72 of 2008 S. 20 of Act No. 101 of 1965 S. 20 of Act No. 72 of 2008 S. 21 of Act No. 101 of 1965 S. 21 of Act No. 72 of 2008 S. 22 of Act No. 101 of 1965 S. 22 of Act No. 72 of 2008 S. 22A of Act No. 101 of 1965 S. 23 of Act No. 72 of 2008 S. 22B of Act No. 101 of 1965 S. 24 of Act No. 72 of 2008 S. 22C of Act No. 101 of 1965 S. 25 of Act No. 72 of 2008 S. 22D of Act No. 101 of 1965 S. 26 of Act No. 72 of 2008 S. 22E of Act No. 101 of 1965 S. 27 of Act No. 72 of 2008 S. 22F of Act No. 101 of 1965

S. 28 of Act No. 72 of 2008 S. 22H of Act No. 101 of 1965 S. 29 of Act No. 72 of 2008 S. 23 of Act No. 101 of 1965 S. 30 of Act No. 72 of 2008 S. 24 of Act No. 101 of 1965 S. 31 of Act No. 72 of 2008 S. 24A of Act No. 101 of 1965 (insertion) S. 32 of Act No. 72 of 2008 S. 25 of Act No. 101 of 1965 S. 33 of Act No. 72 of 2008 S. 26 of Act No. 101 of 1965 S. 34 of Act No. 72 of 2008 S. 27 of Act No. 101 of 1965 S. 35 of Act No. 72 of 2008 S. 28 of Act No. 101 of 1965 S. 36 of Act No. 72 of 2008 S. 29 of Act No. 101 of 1965 S. 37 of Act No. 72 of 2008 S. 30 of Act No. 101 of 1965 S. 38 of Act No. 72 of 2008 S. 31 of Act No. 101 of 1965 S. 39 of Act No. 72 of 2008 S. 33A of Act No. 101 of 1965 S. 40 of Act No. 72 of 2008 S. 34A of Act No. 101 of 1965 S. 41 of Act No. 72 of 2008 S. 35 of Act No. 101 of 1965 S. 42 of Act No. 72 of 2008 S. 36 of Act No. 101 of 1965 S. 43 of Act No. 72 of 2008 S. 37A of Act No. 101 of 1965

GENERAL NOTE

There is a discrepancy between the English and Afrikaans texts of section 1 of Act No. 94 of 1991, which affects section 1 of this Act.

The definition of “landdros” in section 1 of the Afrikaans text of this Act has been amended by the Judicial Matters Amendment Act, No. 66 of 2008. We suggest that reference be made to the Afrikaans Act for this definition.

ACT

To provide for the registration of medicines and related substances intended for human and for animal use; to provide for the establishment of a Medicines Control Council; to provide that such council shall be a juristic person; to make other provision for the constitution of the council; to provide that a member of the council or committee shall declare his or her commercial interest related to the pharmaceutical or health care industry; to provide that the appointment of members of the executive committee is subject to the approval of the Minister; to provide for the control of medicines and scheduled substances and medical devices; to make further provision for the prohibition on the sale of medicines which are subject to registration and are not registered; to provide for procedures that will expedite the registration of essential medicines, and for the re-evaluation of all medicines after five years; to provide for measures for the supply of more affordable medicines in certain circumstances; to provide that labels be approved by the council; to prohibit sampling and bonusing of medicines; to provide for the licensing of certain persons to compound, dispense or manufacture medicines and medical devices and also to act as wholesalers or distributors; to provide for the generic substitution of medicines; to provide for the establishment of a pricing committee; to regulate the purchase and sale of medicines by manufacturers, distributors, wholesalers, pharmacists and persons licensed to dispense medicines; to make new provisions for appeals against decisions of the Director-General or the council; to provide that the council may acquire and appropriate funds; to regulate the Minister’s power to make regulations; to provide for the rationalization of certain laws relating to medicines and related substances that have remained in force in various territories on the national territory of the Republic by virtue of item 2 of Schedule 6 to the Constitution of the Republic of South Africa, 1996; and to provide for matters connected therewith.

[Long title substituted by s. 37 of Act No. 65 of 1974, by s. 15 of Act No. 17 of 1979, by s. 22 of Act No. 94 of 1991, by s. 29 of Act No. 90 of 1997 and by s. 13 of Act No. 59 of 2002.]ARRANGEMENT OF SECTIONS

1. Definitions 2. Establishment, powers and functions of Medicines Control Council 3. Constitution of council

4. Period of office and remuneration of members of the council 5. Chairman and vice-chairman 6. Disqualifications, vacation of office, filling of vacancies and declaration of interest 7. Meetings of the council 8. Quorum, majority decision and chairman’s casting vote 9. Appointment of executive committee and other committees 10. . . . . . . 11. . . . . . . 12. Appointment of Registrar and Deputy Registrar of Medicines 13. Medicines register 14. Prohibition on the sale of medicines which are subject to registration and are not registered 15. Registration of medicines 15A. Amendment of entries in register 15B. Transfer of certificates of registration 15C. Measures to ensure supply of more affordable medicines 16. Cancellation of registration 17. Notification of registration or cancellation of registration in Gazette

18. Labels and advertisements 18A. Bonusing 18B. Sampling of medicines 18C. Marketing of medicines 19. Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to the council 20. Publication or distribution of false advertisements concerning medicines 21. Council may authorize sale of unregistered medicine for certain purposes 22. Director-General to cause certain information to be furnished 22A. Control of medicines and Scheduled substances 22B. Publication of information relating to medicine, Scheduled substance or medical device 22C. Licensing 22D. Period of validity and renewal of licence 22E. Suspension and cancellation of licence 22F. Generic substitution 22G. Pricing committee 22H. Purchase and sale of medicines by wholesalers

23. Disposal of undesirable medicines 24. Appeal against decision of council or Director-General 25. Privileges of council and committees 26. Inspectors 27. Analysts, pharmacologists and pathologists 28. Powers of inspectors 29. Offences 30. Penalties 31. Procedure and evidence 32. . . . . . . 33. Act or omission by manager, agent or employee 33A. Funds of council 34. Preservation of secrecy 34A. Delegation of powers 35. Regulations 36. Exclusion of any drug from operation of Act 36A. Minister may prohibit the manufacture, sale or use of certain veterinary medicines

37. . . . . . . 37A. Amendment of Schedules 38. Operation of Act in relation to other laws 39. State bound 40. Short title Schedule 0 Schedule 1 Schedule 2 Schedule 3 Schedule 4 Schedule 5 Schedule 6 Schedule 7 Schedule 8 Schedule 9 . . . . . .

1. Definitions.—(1) In this Act, unless the context otherwise indicates—

“advertisement”, in relation to any medicine or Scheduled substance, means any written,

pictorial, visual or other descriptive matter or verbal statement or reference—

(a)

appearing in any newspaper, magazine, pamphlet or other publication; or[Para. (a) substituted by s. 1 (a) of Act No. 20 of 1981.]

Wording of Sections

(b)

distributed to members of the public; or(c)

brought to the notice of members of the public in any manner whatsoever,which is intended to promote the sale of that medicine or Scheduled substance; and “advertise” has a corresponding meaning;

“analyst” means an analyst to whom authority has been granted under section 27;

“appeal board” . . . . . .

[Definition of “appeal board” deleted by s. 1 (a) of Act No. 94 of 1991.]

Wording of Sections

“approved name”, in relation to a medicine, means the international non-proprietary name (INN) of such medicine or, where no such name exists, such other name as the council may determine, not being a brand name or trade name registered in terms of the Trade Marks Act, 1993 (Act No. 194 of 1993);

[Definition of “approved name” substituted by s. 1 (a) of Act No. 90 of 1997.]

Wording of Sections

“certificate of registration” means a certificate of registration issued under section 15 (4), 15A (4) or 15B (4);

[Definition of “certificate of registration” inserted by s. 1 (b) of Act No. 20 of 1981.]

“council” means the Medicines Control Council established by section 2;

“dentist” means a person registered as such under the Health Professions Act, 1974;

[Definition of “dentist” substituted by s. 1 (b) of Act No. 90 of 1997.]

Wording of Sections

“Director-General” means the Director-General: Health;

[Definition of “Director-General” inserted by s. 1 (c) of Act No. 20 of 1981 and substituted by s. 1 (b) of Act No. 94 of 1991 and by s. 1 (c) of Act No. 90 of 1997.]

Wording of Sections

“export” includes deliver or supply within the Republic for dispatch to any destination outside the Republic;

[Definition of “export” inserted by s. 1 (a) of Act No. 17 of 1979.]

“hospital” means any institution established as a hospital or a nursing home or registered as such in terms of any law;

“immediate container”, in relation to a medicine or Scheduled substance, means a container which is in direct contact with the medicine or substance;

[Definition of “immediate container” inserted by s. 1 (b) of Act No. 17 of 1979.]

“inspector” means a person authorized as such under section 26;

“interchangeable multi-source medicine” means medicines that contain the same active substances which are identical in strength or concentration, dosage form and route of administration and meet the same or comparable standards, which comply with the requirements for therapeutic equivalence as prescribed;

[Definition of “interchangeable multi-source medicine” inserted by s. 1 (d) of Act No. 90 of 1997.]

“label”, when used as a verb, means brand, mark or otherwise designate or describe, and when used as a noun, means any brand or mark or any written, pictorial or other descriptive matter appearing on or attached to or packed with and referring to any article or the package containing any article;“magistrate” means a magistrate as defined in section 1 of the Magistrates Act, 1993 (Act No. 90 of 1993), and includes an additional magistrate and an assistant magistrate;

[Definition of “magistrate” inserted by s. 1 (a) of Act No. 59 of 2002.]

“Medical Act” . . . . . .

[Definition of “Medical Act” deleted by s. 1 (e) of Act No. 90 of 1997.]

Wording of Sections

“medical device” means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent—

(a)

used or purporting to be suitable for use or manufactured or sold for use in—(i)

the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or(ii)restoring, correcting or modifying any somatic or psychic or organic function; or(iii)the diagnosis or prevention of pregnancy,and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or

(b)

declared by the Minister by notice in the Gazette to be a medical device,and includes any part or an accessory of a medical device;

[Definition of “medical device” inserted by s. 1 (c) of Act No. 94 of 1991.]

“medical practitioner” means a person registered as such under the Health Professions Act, 1974, and includes an intern registered under that Act;

[Definition of “medical practitioner” substituted by s. 1 (c) of Act No. 17 of 1979, by s. 1 (d) of Act No. 94 of 1991 and by s. 1 ( f ) of Act No. 90 of 1997.]

Wording of Sections

“medicinal purpose” . . . . . .

[Definition of “medicinal purpose” deleted by s. 1 (e) of Act No. 94 of 1991.]

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“medicine” means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in—

(a)

the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or(b)

restoring, correcting or modifying any somatic or psychic or organic function in man,and includes any veterinary medicine;

[Definition of “medicine” substituted by s. 1 (d) of Act No. 17 of 1979.]

Wording of Sections

“Minister” means the Minister of Health;

[Definition of “Minister” substituted by s. 1 (d) of Act No. 20 of 1981, by s. 1 ( f ) of Act No.

94 of 1991 and by s. 1 (g) of Act No. 90 of 1997.]

Wording of Sections

“nurse” means a person registered as such under the Nursing Act, 1978 (Act No. 50 of 1978);

[Definition of “nurse” inserted by s. 1 (g) of Act No. 94 of 1991.]

“package” means anything in or by which any medicine or Scheduled substance is enclosed, covered, contained or packed;

“pathologist” means a pathologist to whom authority has been granted under section 27;

“pharmacist” means a person registered as such under the Pharmacy Act, 1974;

[Definition of “pharmacist” substituted by s. 1 (e) of Act No. 17 of 1979 and by s. 1 (h) of Act No. 94 of 1991.]

Wording of Sections

“pharmacist intern” means a person registered as such under the Pharmacy Act, 1974;

[Definition of “pharmacist intern” inserted by s. 1 (h) of Act No. 90 of 1997.]

“pharmacist’s assistant” means a person registered as such under the Pharmacy Act, 1974;

[Definition of “pharmacist’s assistant” inserted by s. 1 ( f ) of Act No. 17 of 1979, deleted by s. 1 (i) of Act No. 94 of 1991 and inserted by s. 1 (h) of Act No. 90 of 1997.]

“pharmacologist”, except for the purposes of section 24 (1) (c), means a pharmacologist to whom authority has been granted under section 27;

[Definition of “pharmacologist” substituted by s. 1 ( j) of Act No. 94 of 1991.]

Wording of Sections

“pharmacy Board” . . . . . .

[Definition of “pharmacy Board” deleted by s. 1 (k) of Act No. 94 of 1991.]

Wording of Sections

“practitioner” means a person registered as such under the Allied Health Professions Act, 1982 (Act No. 63 of 1982);

[Definition of “practitioner” inserted by s. 1 (l) of Act No. 94 of 1991 and substituted by s. 1 (i) of Act No. 90 of 1997 and by s. 1 (b) of Act No. 59 of 2002.]

Wording of Sections

“prescribed” means prescribed by or under this Act;

“public” includes a section of the public concerned with manufacturing, dispensing, selling or administering, or the issue of prescriptions for, medicines or a Scheduled substance;

[Definition of “public” inserted by s. 1 (e) of Act No. 20 of 1981.]

“register”, when used as a noun, means the register referred to in section 13, and when used as a verb, means to enter in such register;

“registered” means entered in the register;

“registrar” means the Registrar of Medicines appointed under section 12;

“regulation” means a regulation made and in force under this Act;

“Scheduled substance” means any medicine or other substance prescribed by the Minister under section 22A;

[Definition of “Scheduled substance” substituted by s. 1 (m) of Act No. 94 of 1991.]

Wording of Sections

“Schedule 1 substance” . . . . . .

[Definition of “Schedule 1 substance” deleted by s. 1 (n) of Act No. 94 of 1991.]

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“Secretary” . . . . . .[Definition of “Secretary” deleted by s. 1 ( f ) of Act No. 20 of 1981.]

Wording of Sections

“sell” means sell by wholesale or retail and includes import, offer, advertise, keep, expose, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for purposes of sale, and barter or exchange or supply or dispose of to any person whether for a consideration or otherwise; and “sale” and “sold” have corresponding meanings;

“this Act” includes any regulation;

“the territory” . . . . . .

[Definition of “the territory” deleted by s. 1 (o) of Act No. 94 of 1991 and by s. 1 of Act No. 49 of 1996.]

Wording of Sections

“trainee pharmacist” . . . . . .

[Definition of “trainee pharmacist” deleted by s. 1 (o) of Act No. 94 of 1991.]

Wording of Sections

“unqualified assistant” . . . . . .

[Definition of “unqualified assistant” deleted by s. 1 (g) of Act No. 17 of 1979.]

Wording of Sections

“veterinarian” means a person registered as such under the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982);

[Definition of “veterinarian” substituted by s. 1 (p) of Act No. 94 of 1991.]

Wording of Sections

“veterinary medicine” means any substance or mixture of substances, other than a stock remedy or farm feed to be registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No. 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with vertebrates, for the treatment, diagnosis, prevention or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, or for curing, correcting or modifying any somatic or organic function, or for correcting or modifying behaviour.

[Definition of “veterinary medicine” added by s. 1 (h) of Act No. 17 of 1979.]

(2) Subject to section 15C, a medicine shall, notwithstanding the fact that its components are identical to those of any other medicine as to physical characteristics, quantity and quality, for the purpose of this Act not be regarded as being the same medicine as that other medicine if registration thereof is not applied for by the holder of the certificate of registration issued in respect of that other medicine.

[Sub-s. (2) substituted by s. 1 (i) of Act No. 17 of 1979, by s. 1 (g) of Act No. 20 of 1981 and by s. 1 ( j) of Act No. 90 of 1997.]

Wording of Sections

(3) In determining whether or not the registration or availability of a medicine is in the public interest, regard shall be had only to the safety, quality and therapeutic efficacy thereof in relation to its effect on the health of man or any animal, as the case may be.

[Sub-s. (3) substituted by s. 1 ( j) of Act No. 17 of 1979.]

Wording of Sections

(4) International tendering for medicines shall be allowed in the prescribed manner and on the prescribed conditions.

[S. 1 substituted by s. 1 (1) of Act No. 65 of 1974. Sub-s (4) added by s. 1 (k) of Act No. 90

of 1997.]

Wording of Sections

Wording of Sections def: advertisement par(a) of Act 101 of 1965 prior to amendment by Act 20 of 1981

Wording of Sections def: appeal board of Act 101 of 1965 prior to amendment by Act 94 of 1991

Wording of Sections def: approved name of Act 101 of 1965 prior to amendment by Act 90 of 1997

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Wording of Sections def: Director-General of Act 101 of 1965 prior to amendment by Act 94 of 1991def: Director-General of Act 101 of 1965 prior to amendment by Act 90 of 1997

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Wording of Sections def: medical practitioner of Act 101 of 1965 prior to amendment by Act 17 of 1979def: medical practitioner of Act 101 of 1965 prior to amendment by Act 94 of 1991def: medical practitioner of Act 101 of 1965 prior to amendment by Act 90 of 1997 Wording of Sections def: medicinal purpose of Act 101 of 1965 prior to amendment by Act 94 of 1991

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Wording of Sections def: Secretary of Act 101 of 1965 prior to amendment by Act 20 of 1981

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Wording of Sections s 1(2) of Act 101 of 1965 prior to amendment by Act 17 of 1979s 1(2) of Act 101 of 1965 prior to amendment by Act 20 of 1981s 1(2) of Act 101 of 1965 prior to amendment by Act 90 of 1997



2. Establishment, powers and functions of Medicines Control Council.—(1) There is hereby established a council to be known as the Medicines Control Council, which may exercise the powers and shall perform the functions conferred upon or assigned to the council by this Act.

(2) The Council may advise the Minister or furnish a report to the Minister on any matter referred to the council by the Minister for consideration and arising from the application of this Act.


(3) The council shall be a juristic person.

[S. 2 substituted by s. 2 (1) of Act No. 65 of 1974. Sub-s. (3) added by s. 2 of Act No. 90 of 1997.]

Wording of Sections


3. Constitution of council.—The council shall consist of so many members, but not more than 24, as the Minister may from time to time determine and appoint.

[S. 3 amended by s. 3 of Act No. 65 of 1974, by s. 1 of Act No. 36 of 1977, by s. 2 of Act No. 17 of 1979, by s. 46 of Act No. 97 of 1986 and by s. 3 of Act No. 94 of 1991 and substituted by s. 3 of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 3 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 3 of Act 101 of 1965 prior to amendment by Act 36 of 1977s 3 of Act 101 of 1965 prior to amendment by Act 17 of 1979s 3 of Act 101 of 1965 prior to amendment by Act 97 of 1986s 3 of Act 101 of 1965 prior to amendment by Act 94 of 1991s 3 of Act 101 of 1965 prior to amendment by Act 90 of 1997

4. Period of office and remuneration of members of the council.—(1) A member of the

council shall, subject to the provisions of section 6 (3), be appointed for a period of five years but a new council shall be appointed within six months after the date of commencement of the Medicines and Related Substances Control Amendment Act, 1997.


Wording of Sections

(2) Any person whose period of office as a member of the council has expired, shall be eligible for reappointment: Provided that no person who has served two periods of five years as a member shall be so eligible.


Wording of Sections

(3) The Minister shall give notice in the Gazette of the appointment of any member of the council and the date from which his membership commences and, in the case of a member appointed to fill a casual vacancy on the council, the period for which he is appointed.

(4) A member of the council (other than a person who is in the full-time employment of the State) shall receive such remuneration and such allowances in respect of his services as a member of the council or of any committee thereof, as the Minister in consultation with the Minister of Finance may determine.[Sub-s. (4) substituted by s. 4 (1) of Act No. 65 of 1974.]

Wording of Sections




5. Chairman and vice-chairman.—(1) One of the members of the council shall be designated by the Minister as chairman of the council and another member shall be designated by the Minister as vice-chairman to act as chairman during the absence of the chairman.

[Sub-s. (1) amended by s. 46 of Act No. 97 of 1986.]

Wording of Sections

(2) The vice-chairman, when acting as chairman as provided in subsection (1), shall have all the powers and discharge all the duties of the chairman.

Wording of Sections

s 5(1) of Act 101 of 1965 prior to amendment by Act 97 of 1986

6. Disqualifications, vacation of office, filling of vacancies and declaration of interest.—(1) No person shall be appointed as a member of the council—

(a)

who is an unrehabilitated insolvent;(b)

who is disqualified under the Veterinary and Para-Veterinary Professions Act, 1982, the Chiropractors, Homeopaths and Allied Health Service Professions Act, 1982, the Health Professions Act, 1974, or the Pharmacy Act, 1974, from carrying on his or her profession, while so disqualified;(c)

who is not a South African citizen permanently resident in the Republic; or(d)

who is employed in the pharmaceutical industry.(2) A member of the council shall vacate his or her office—

(a)

if he or she is or becomes subject to any disqualification referred to in subsection (1);(b)

. . . . . .[Para. (b) deleted by s. 2 (a) of Act No. 59 of 2002.]

Wording of Sections

(c)

if he or she becomes mentally ill, as defined in the Mental Health Act, 1973 (Act No. 18 of 1973);(d)

if he or she is convicted of an offence and is sentenced to imprisonment without the option of a fine;(e)

if he or she has been absent from more than two consecutive meetings of the council without the council’s leave; or( f )

if the Minister is satisfied that the member has violated the internal rules of conduct as determined by the council and published by notice in the Gazette.(3) If the office of any member of the council becomes vacant before the expiration of the period for which he or she was appointed, the Minister may, appoint another person to hold

office for the unexpired portion of the period for which his or her predecessor was appointed.


Wording of Sections

(4) A member of the council or of a committee appointed in terms of section 9 shall declare his or her commercial interests related to the pharmaceutical or health care industry, which interests shall include, but shall not be limited to, any consultancy, paid or unpaid, any research grant from which the member directly or indirectly benefits, or any equity holding or any executive or non-executive directorship or any other payment or benefit in kind, and shall recuse himself or herself from any discussion or decision-making to which the said interests relate or may relate.

[S. 6 amended by s. 5 of Act No. 65 of 1974, by s. 3 of Act No. 17 of 1979, by s. 46 of Act No. 97 of 1986, by s. 4 of Act No. 94 of 1991 and by s. 1 of Act No. 49 of 1996 and substituted by s. 5 of Act No. 90 of 1997.]

Wording of Sections



Wording of Sections s 6 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 6 of Act 101 of 1965 prior to amendment by Act 17 of 1979s 6 of Act 101 of 1965 prior to amendment by Act 97 of 1986s 6 of Act 101 of 1965 prior to amendment by Act 94 of 1991s 6 of Act 101 of 1965 prior to amendment by Act 49 of 1996s 6 of Act 101 of 1965 prior to amendment by Act 90 of 1997

7. Meetings of the council.—(1) The first meeting of the council shall be held at a time and place to be fixed by the Minister, and all subsequent meetings shall, subject to the provisions of subsection (2), be held at such times and places as may be fixed by the council: Provided that the council shall hold at least one meeting in any period of three months and, if at the close of any meeting the council has not fixed the time and place for its next meeting, such time and place shall be fixed by the chairman.

(2) The chairman of the council may at any time call a special meeting of the council to be held at such time and place as he may determine, and shall, upon a written request by the Minister or a written request signed by not less than three members of the council, call a special meeting thereof to be held within thirty days after the date of receipt of such request, at such time and place as he may determine.


Wording of Sections


8. Quorum, majority decision and chairman’s casting vote.—(1) A majority of all the members of the council shall form a quorum for any meeting of the council.

(2) At all meetings of the council the chairman, or in his absence the vice-chairman, or in the absence of both the chairman and the vice-chairman, some other member of the council chosen by the members present, shall preside.

(3) Save as provided in section thirty-six, the decision of a majority of the members of the council present at any meeting thereof shall constitute a decision of the council, and in the event of an equality of votes in regard to any matter, the person presiding at the meeting in question shall have a casting vote in addition to his deliberative vote.

(4) No decision or act done under the authority of the council shall be invalid by reason only of an interim vacancy on the council or of the fact that a person who is disqualified from being a member of the council, or with respect to whose appointment the provisions of this Act have not been observed, sat or acted as a member at the time when the decision was taken or the act was performed or authorized, if the decision was taken or the act was performed or authorized by the requisite majority of the members of the council present at the time who were entitled to sit and act as members.

9. Appointment of executive committee and other committees.—(1) The council may appoint—

(a)

subject to the approval of the Minister, from among its members an executive committee; and[Para. (a) substituted by s. 6 of Act No. 90 of 1997.]

Wording of Sections

(b)

subject to the approval of the Minister, such other committees as it may deem necessary, to investigate and report to it on any matter within the purview of the council in terms of this Act.(2) The executive committee may, subject to the directions of the council, exercise all the powers and perform all the functions of the council during periods between meetings of the council, but shall not have the power, save in so far as the council otherwise directs, to set aside or vary any decision of the council, and any action taken or decision made by the executive committee shall be subject to review at the first ensuing meeting of the council.

(3) The council may appoint such persons, including persons other than members of the council, as it may deem fit, to be members of any committee appointed in terms of paragraph (b) of subsection (1).

(4) There shall be payable to a member of a committee of the council (other than a member

of the council or a person who is in the full-time employment of the State) such remuneration and such allowances, while he is engaged in the carrying out of his duties as a member of such committee, as the Minister may, in consultation with the Minister of Finance, determine.


Wording of Sections



10. . . . . . .

[S. 10 substituted by s. 8 (1) of Act No. 65 of 1974 (English only), amended by s. 4 of Act No. 17 of 1979 and by s. 46 of Act No. 97 of 1986 and repealed by s. 5 of Act No. 94 of 1991.]

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11. . . . . . .

[S. 11 amended by s. 9 of Act No. 65 of 1974, by s. 5 of Act No. 17 of 1979 and by s. 46 of Act No. 97 of 1986 and repealed by s. 6 of Act No. 94 of 1991.]

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12. Appointment of Registrar and Deputy Registrar of Medicines.—(1) The Minister may, after consultation with the council, appoint a Registrar and one or more Deputy Registrars or revoke such an appointment.

(2) The Registrar shall exercise the powers and perform the duties assigned to, or imposed upon him or her in terms of this Act and such other powers and duties as may from time to time be assigned to or imposed upon him or her by the council, Minister or Director-General.

(3) A Deputy Registrar shall assist the Registrar in the exercise of his or her powers and the

performance of his or her duties and may, subject to the approval of the Registrar, exercise any power conferred upon the Registrar.

[S. 12 substituted by s. 10 (1) of Act No. 65 of 1974, amended by s. 7 of Act No. 90 of 1997 and substituted by s. 3 of Act No. 59 of 2002.]

Wording of Sections

Wording of Sections s 12 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 12 of Act 101 of 1965 prior to amendment by Act 90 of 1997s 12 of Act 101 of 1965 prior to amendment by Act 59 of 2002

13. Medicines register.—The registrar shall keep in the prescribed form a register, to be known as the medicines register, in which he shall register all medicines the registration of which has been approved by the council, and in which he shall enter all such particulars in regard to such medicines and the holder of the certificate of registration in respect of such medicines as are required by this Act to be entered therein.

[S. 13 amended by s. 11 (1) of Act No. 65 of 1974 (English only) and substituted by s. 2 of Act No. 20 of 1981.]

Wording of Sections

Wording of Sections s 13 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 13 of Act 101 of 1965 prior to amendment by Act 20 of 1981

14. Prohibition on the sale of medicines which are subject to registration and are not registered.—(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine which is subject to registration by virtue of a resolution published in terms of subsection (2) unless it is registered.

(2) (a) The council may from time to time by resolution approved by the Minister, determine that a medicine or class or category of medicines or part of any class or category of medicines mentioned in the resolution shall be subject to registration in terms of this Act.

(b) Any such resolution may also relate only to medicines which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines which were not then so available.


Wording of Sections

(c) Any such resolution shall be published in the Gazette by the registrar and shall come into operation on the date on which it is so published.

(3) In the case of a medicine which was available for sale in the Republic immediately prior to the date of publication in the Gazette of the resolution by virtue of which it is subject to

registration in terms of this Act, the provisions of subsection (1) shall come into operation—

(a)

if no application for the registration of such medicine is made within the period of six months immediately succeeding that date, on the expiration of that period; or(b)

if application for the registration of such medicine is made within the said period, on the date one month after the date on which a notice in respect of such medicine is published in the Gazette in terms of section 15 (10) or section 17 (a).[Sub-s. (3) amended by s. 7 (b) of Act No. 94 of 1991.]

Wording of Sections

(4) The provisions of subsection (1) shall not apply in respect of the sale of any medicine—

(a)

compounded in the course of carrying on his or her professional activities by a pharmacist, veterinarian or person who is the holder of a licence contemplated in section 22C (1) (a), for a particular patient in a quantity not greater than the quantity required for treatment as determined by the medical practitioner, pharmacist, practitioner or veterinarian; or(b)

compounded by a pharmacist in a quantity not greater than that prescribed by regulation for sale in the retail trade, subject to the conditions likewise prescribed or in a quantity for a particular person or animal as prescribed by a medical practitioner or a dentist or a veterinarian or a practitioner or a nurse or other person registered under the Health Professions Act, 1974, and referred to in section 22A, as the case may be,if such medicine does not contain any component the sale of which is prohibited by this Act or any component in respect of which an application for registration has been rejected, and is not or has not been advertised: Provided that the active components of such medicine appear in another medicine which has been registered under this Act.

[Sub-s. (4) substituted by s. 6 of Act No. 17 of 1979, by s. 7 (c) of Act No. 94 of 1991 and by s. 8 (a) of Act No. 90 of 1997.]

Wording of Sections

(5) . . . . . .

[S. 14 substituted by s. 1 (1) of Act No. 29 of 1968 and by s. 12 (1) of Act No. 65 of 1974. Sub-s. (5) deleted by s. 8 (b) of Act No. 90 of 1997.]

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Wording of Sections s 14 of Act 101 of 1965 prior to amendment by Act 29 of 1968s 14 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 14(5) of Act 101 of 1965 prior to amendment by Act 90 of 1997

15. Registration of medicines.—(1) Every application for the registration of a medicine shall be submitted to the registrar in the prescribed form and shall be accompanied by the prescribed particulars and samples of the relevant medicine and by the prescribed registration fee.

(2) The registrar shall—

(a)as soon as possible after receipt by him or her of any such application submit the application together with any particulars and samples which accompanied the application to the council for consideration and shall simultaneously inform the applicant in writing that the application has been so submitted;(b)

ensure that such an application in respect of medicine which appears on the latest Essential Drug List or medicine which does not appear thereon but which, in the opinion of the Minister, is essential for national health is subject to such procedures as may be prescribed in order to expedite the registration.[Sub-s. (2) substituted by s. 9 (a) of Act No. 90 of 1997.]

Wording of Sections

(3) (a) If after consideration of any such application and after any investigation or enquiry which it may consider necessary the council is satisfied that the medicine in question is suitable for the purpose for which it is intended and complies with the prescribed requirements and that registration of that medicine is in the public interest, it shall approve of the registration thereof.

(b) If the council is not so satisfied it shall cause the applicant to be notified in writing of the reasons why it is not so satisfied and cause the applicant to be informed that he or she may within a period of one month after the date of the notification furnish the registrar with his or her comments on the council’s reasons for not being so satisfied.

[Para. (b) substituted by s. 9 (b) of Act No. 90 of 1997.]

Wording of Sections

(c) If no such comments are submitted by the applicant within the said period, or if after consideration of any comments so submitted the council is still not satisfied as aforesaid, it shall reject the application.

(4) When the council has approved of the registration of any medicine the registrar shall register that medicine and shall enter in the register such particulars in regard to the medicine as are required by this Act to be so entered and shall issue to the applicant a certificate of registration in the prescribed form in respect of that medicine.

(5) Every medicine shall be registered under such name as the council may approve.

(6) The registrar shall allocate to every medicine registered under this Act a registration number which shall be recorded in the register opposite the name of such medicine and which shall be stated in the certificate of registration issued in respect of such medicine.

(7) Any registration under this section, including the registration of medicines already registered, shall be valid for a period of five years and may be made subject to such conditions as may with regard to the succeeding provisions of this section be determined by the council.

[Sub-s. (7) substituted by s. 9 (c) of Act No. 90 of 1997.]Wording of Sections

(8) No condition shall be imposed under subsection (7) whereby the sale of the medicine in question by any person other than a pharmacist is prohibited or until after the applicant has in writing been notified by the registrar that the imposition of such condition is contemplated and invited to submit written representations to the council in regard to the matter.

(9) If no such representations are lodged with the registrar by the applicant concerned within a period of one month after the receipt by him or her of any notification referred to in subsection (8), or if after consideration of any such representations the council is still of the opinion that the condition in question should be imposed, the council shall direct the registrar to register the medicine concerned subject to the said condition.

[Sub-s. (9) substituted by s. 9 (d) of Act No. 90 of 1997.]

Wording of Sections

(10) Notice of the rejection of an application under this section in respect of a medicine referred to in subsection (3) of section 14 shall be given in the Gazette by the registrar—

(a)

if no appeal is lodged against the rejection within the period referred to in section 24, as soon as possible after the expiration of that period; or[Para. (a) substituted by s. 8 of Act No. 94 of 1991.]

Wording of Sections

(b)

if any appeal so lodged is dismissed, as soon as possible after the decision dismissing the appeal has been given.(11) The registrar shall as soon as possible after the date of expiry of the appropriate period referred to in section 14 (3) publish in the Gazette the prescribed particulars in respect of all applications for registration received by him or her prior to such date.

[Sub-s. (11) substituted by s. 9 (e) of Act No. 90 of 1997.]

Wording of Sections

(12) For the purposes of this section, “Essential Drug List” means the list of essential drugs included in the latest edition of the official publication relating to guidelines for standard treatment which is compiled by the Department of Health.

[S. 15 amended by s. 2 of Act No. 29 of 1968 and substituted by s. 13 of Act No. 65 of 1974. Sub-s. (12) added by s. 9 ( f ) of Act No. 90 of 1997.]

Wording of Sections








15A. Amendment of entries in register.—(1) The entry made in the register with respect to any medicine may on application by the holder of the certificate of registration issued in respect of such medicine be amended by the registrar with the approval of the council.

(2) Application for the amendment of an entry in the register shall be made to the registrar on the prescribed form and shall be accompanied by the prescribed application fees.

(3) The registrar shall as soon as possible after the receipt of any such application submit the

application to the council for consideration.

(4) If the council grants its approval in respect of any application submitted to it in terms of subsection (3) the registrar shall make the required amendments in the register and, if necessary, cancel the existing certificate of registration in respect of such medicine and issue a new certificate of registration on the prescribed form to the applicant in respect of such medicine.


15B. Transfer of certificates of registration.—(1) certificate of registration may with the approval of the council be transferred by the holder thereof to any other person.

(2) Application for approval of the transfer of a certificate of registration shall be made to the registrar on the prescribed form and shall be accompanied by the certificate of registration in question and the prescribed application fees.

(3) The registrar shall as soon as practicable after the receipt of any such application submit the application to the council for consideration.(4) If the council grants any application submitted to it in terms of subsection (3) the registrar shall make the necessary entries in the register relating to the person to whom the certificate of registration is transferred, cancel the existing certificate of registration and issue a new certificate of registration on the prescribed form to such person in respect of the relevant medicine.

[S. 15B inserted by s. 3 of Act No. 20 of 1981.]

15C. Measures to ensure supply of more affordable medicines.—The Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may—

(a)

notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act No. 57 of 1978), determine that the rights with regard to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which has been put onto the market by the owner of the medicine, or with his or her consent;(b)

prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the council in the prescribed manner, may be imported;(c)

prescribe the registration procedure for, as well as the use of, the medicine referred to in paragraph (b).[S. 15C inserted by s. 10 of Act No. 90 of 1997.]

16. Cancellation of registration.—(1) If the council—

(a)

is of the opinion that any person has failed to comply with any condition subject to which any medicine has been registered; or(b)

is of the opinion that any medicine does not comply with any prescribed requirement; or(c)

is of the opinion that it is not in the public interest that any medicine shall be available to the public,the council shall cause notice in writing to be given accordingly by the registrar to the holder of the certificate of registration issued in respect of that medicine.

[Sub-s. (1) amended by s. 14 of Act No. 65 of 1974 (English only) and substituted by s. 4 (a) of Act No. 20 of 1981.]

Wording of Sections

(2) Any such notice shall specify the grounds on which the council’s opinion is based, and shall indicate that the person to whom it is directed may within one month after receipt thereof submit to the registrar any comments he may wish to put forward in connection with the matter.

(3) If no such comments are so submitted, or if after consideration of any comments so submitted the council is of the opinion that the registration of the medicine in question should be cancelled, the council may direct the registrar to cancel the registration thereof.

[Sub-s. (3) amended by s. 14 of Act No. 65 of 1974 (English only).]

Wording of Sections

(4) If the person who is the holder of the certificate of registration issued in respect of any medicine fails to pay the prescribed annual fee in respect of the retention of the registration of that medicine before or on the prescribed date or such later date as the registrar may with the approval of the council determine on application by that person, the registrar shall cancel the registration of that medicine.

[Sub-s. (4) added by s. 3 of Act No. 29 of 1968, amended by s. 14 of Act No. 65 of 1974 and substituted by s. 4 (b) of Act No. 20 of 1981 (English only).]

Wording of Sections

Wording of Sections s 16(1) of Act 101 of 1965 prior to amendment by Act 65 of 1974s 16(1) of Act 101 of 1965 prior to amendment by Act 20 of 1981



17. Notification of registration or cancellation of registration in Gazette.—The registrar shall give notice in the Gazette of the registration or cancellation of the registration of any medicine in terms of this Act, and shall in such notice specify—

(a)

in the case of a registration of any medicine, the name under which such medicine is registered, the active components of such medicine, the name of the person who applied for the registration of such medicine, the number allocated to it in terms of section 15 and the conditions (if any) subject to which it is registered;(b)

in the case of a cancellation of the registration of any medicine, the name under which such medicine was registered, the name of the holder of the certificate of registration issued in respect of such medicine and the number which was allocated to it in terms of section 15.[S. 17 amended by s. 4 of Act No. 29 of 1968 and substituted by s. 15 of Act No. 65 of 1974. Para. (b) substituted by s. 5 of Act No. 20 of 1981.]

Wording of Sections

Wording of Sections s 17 of Act 101 of 1965 prior to amendment by Act 29 of 1968s 17 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 17(b) of Act 101 of 1965 prior to amendment by Act 20 of 1981

18. Labels and advertisements.—(1) No person shall sell any medicine or Scheduled substance unless the immediate container or the package in which that medicine or Scheduled substance is sold bears a label stating the prescribed particulars.

(2) No person shall advertise any medicine or Scheduled substance for sale unless such advertisement complies with the prescribed requirements.

(3) The label referred to in subsection (1) shall be approved by the council.


(4) The council may authorise a deviation from the prescribed format and contents of any label.


(5) The Minister may prescribe additional requirements for the labelling of medicines.

[S. 18 substituted by s. 16 of Act No. 65 of 1974 and by s. 7 of Act No. 17 of 1979. Sub-s. (5) added by s. 11 of Act No. 90 of 1997.]

Wording of Sections


18A. Bonusing.—No person shall supply any medicine according to a bonus system, rebate system or any other incentive scheme.


(Date of commencement: 2 May, 2004.)

18B. Sampling of medicines.—(1) No person shall sample any medicine.

(2) For the purposes of this section “sample” means the free supply of medicines by a manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, but does not include the free supply of medicines for the purposes of clinical trials, donations of medicines to the State, tendering to the State and quality control by inspectors.

(3) The use of medicines or Scheduled substances for exhibition purposes shall be as prescribed.


18C. Marketing of medicines.—The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice.

[S. 18C inserted by s. 12 of Act No. 90 of 1997 and substituted by s. 4 of Act No. 59 of 2002.]

Wording of Sections

Wording of Sections s 18C of Act 101 of 1965 prior to amendment by Act 59 of 2002

19. Prohibition on sale of medicines which do not comply with prescribed requirements and furnishing of information regarding medicines to the council.—(1) No person shall sell any medicine unless it complies with the prescribed requirements.


Wording of Sections

(2) The council may by notice in writing require any person who manufactures or sells or

administers or prescribes any medicine or on whose direction any medicine is administered to furnish it, within a period stipulated in such notice, with any information which such person has in his possession or which such person is in a position to obtain regarding such medicine.


Wording of Sections

(3) The council may, if so requested by any person to whom a notice under subsection (2) is addressed, extend the period stipulated in such notice.


Wording of Sections s 19(2) of Act 101 of 1965 prior to amendment by Act 65 of 1974 20. Publication or distribution of false advertisements concerning medicines.—(1) No person shall—

(a)

publish or distribute or in any other manner whatsoever bring to the notice of the public or cause or permit to be published or distributed or to be so brought to the notice of the public any false or misleading advertisement concerning any medicine; or[Para. (a) amended by s. 18 of Act No. 65 of 1974 (English only).]

Wording of Sections

(b)

in any advertisement make any claim to the effect that the therapeutic efficacy and effect of any medicine is other than that stated by the council in terms of subparagraph (ii) of paragraph (a) of section twenty-two or state or suggest that any medicine should be used for a purpose or under circumstances or in a manner other than that stated by the council in terms of subparagraph (iii) or paragraph (a) of that section.[Para. (b) amended by s. 18 of Act No. 65 of 1974 (English only).]

Wording of Sections

(2) It shall be a sufficient defence in any prosecution for an offence under paragraph (a) of subsection (1) if it is proved to the satisfaction of the court that the accused, not being a person selling the medicine to which the false or misleading advertisement which is the subject of the prosecution relates, did not know, and could not reasonably be expected to have known, that the advertisement was in any respect false or misleading, unless it is proved that the accused failed on demand by the registrar or an inspector or a member of the South African Police to furnish the name and address of the person at whose instance the advertisement was published, distributed or so brought to the notice of the public.

[Sub-s. 2 amended by s. 18 of Act No. 65 of 1974 (English only).]



21. Council may authorize sale of unregistered medicine for certain purposes.—(1) The council may in writing authorize any person to sell during a specified period to any specified person or institution a specified quantity of any particular medicine which is not registered.


Wording of Sections

(2) Any medicine sold in pursuance of any authority under subsection (1) may be used for such purposes and in such manner and during such period as the council may in writing determine.


Wording of Sections

(3) The council may at any time by notice in writing withdraw any authority granted in terms of subsection (1) if effect is not given to any determination made in terms of subsection (2).



22. Director-General to cause certain information to be furnished.—(1) The Director-General shall after consultation with the council, cause, in such manner as the Director-General considers most suitable—

(a)

as soon as practicable after any medicine, other than a veterinary medicine, has been registered, medical practitioners, dentists, pharmacists and the person who applied for the registration of such medicine to be informed—(i)of the name and number under which such medicine is registered and the conditions, if any, subject to which such medicine is registered;(ii)of the therapeutic efficacy and effect of such medicine;(iii)of the purpose for which, the circumstances under which and the manner in which such medicine should be used; and(iv)regarding any other matter concerning such medicine which, in the opinion of the council,

may be of value to them;(b)

as soon as practicable after the registration of any medicine, other than a veterinary medicine, has been cancelled in terms of section 16, medical practitioners, dentists, pharmacists and the holder of the certificate of registration issued in respect of such medicine to be informed of the cancellation of such registration.[Para (b) substituted by s. 6 of Act No. 20 of 1981.]

Wording of Sections

(2) The provisions of subsection (1) shall apply mutatis mutandis in respect of any veterinary medicine, and for the purposes of such application the reference in that subsection to medical practitioners and dentists shall be deemed to be a reference to veterinarians.[S. 22 substituted by s. 20 of Act No. 65 of 1974 and by s. 8 of Act No. 17 of 1979.]

Wording of Sections



22A. Control of medicines and Scheduled substances.—(1) Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine or Scheduled substance, except in accordance with the prescribed conditions.

(2) The Minister may, on the recommendation of the council, prescribe the Scheduled substances referred to in this section.

(3) Any Schedule 0 substance may be sold in an open shop.

(4) Any Schedule 1 substance shall not be sold—

(a)

by any person other than—(i)a pharmacist, or a pharmacist intern or pharmacist’s assistant acting under the personal supervision of a pharmacist;(ii)a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;(iii)a medical practitioner or dentist, who may—(aa)

prescribe such substance;

(bb)

compound and dispense such substance only if he or she is the holder of a licence as contemplated in section 22C (1) (a);(iv)a veterinarian who may prescribe, compound or dispense such substance;(v)a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may—(aa)

prescribe only the Scheduled substances identified in the Schedule for that purpose;(bb)compound and dispense the Scheduled substances referred to in item (aa) only if he or she is the holder of a licence contemplated in section 22C (1) (a);(b)

to any person apparently under the age of 14 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist’s assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 14 years;(c)

unless the seller, other than a manufacturer or wholesale dealer in pharmaceutical products, enters in a prescription book required to be kept in the prescribed manner, the prescribed particulars of such sale.(5) Any Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance shall not be sold by any person other than—

(a)

a pharmacist, pharmacist intern or a pharmacist’s assistant acting under the personal supervision of a pharmacist, who may sell only Schedule 2 substances without a prescription;(b)

a pharmacist or a pharmacist intern or pharmacist’s assistant acting under the personal supervision of a pharmacist, upon a written prescription issued by an authorised prescriber or on the verbal instructions of an authorised prescriber who is known to such pharmacist;(c)

a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;(d)

a medical practitioner or dentist, who may—(i)prescribe such substance;(ii)

compound or dispense such substance only if he or she is the holder of a licence as contemplated in section 22C (1) (a);(e)

a veterinarian who may prescribe, compound or dispense such substance;( f )

a practitioner, a nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may—(i)prescribe only the Scheduled substances identified in the Schedule for that purpose;(ii)compound and dispense the Scheduled substances referred to in subparagraph (i) only if he or she is the holder of a licence contemplated in section 22C (1) (a).(6) Any sale under subsection (5) shall only take place on condition that—

(a)

all the prescribed particulars of every sale shall be recorded in the prescribed manner in a prescription book or other permanent record required to be kept in the prescribed manner;(b)

the authorised prescriber who has given verbal instructions to a pharmacist to dispense a prescription shall within seven days after giving such instructions furnish such pharmacist with a prescription confirming such instructions;(c)

in the case of verbal instructions the treatment period shall not exceed seven days;(d)

if a prescription is not presented for dispensing within 30 days of issue it shall not be dispensed;(e)

in the case of a Schedule 2 substance, such substance may not be supplied to any person apparently under the age of 14 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist’s assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 14 years;( f )

in the case of a Schedule 2, Schedule 3 or Schedule 4 substance, such sale may be repeated if the person who issued the prescription has indicated thereon the number of times it may be dispensed, but not for longer than six months;(g)

in the case of a Schedule 5 substance, such sale shall not be repeated for longer than six months, and then only if the authorised prescriber has indicated on the prescription the

number of times and the intervals at which it may be dispensed;(h)

where a Schedule 5 substance is used for—(i)its anxiolytic, anti-depressant or tranquillising properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted a registered psychiatrist, or, in the case of a psychiatrist, another psychiatrist before issuing a new prescription;(ii)its analgesic properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted another medical practitioner, before issuing a new prescription;(i)

in the case of a Schedule 6 substance, it shall not be repeated without a new prescription being issued;( j)

in an emergency in which the health or life of a patient is at stake, a pharmacist engaged in wholesale practice may, on receipt of a telephonic or telefaxed or other electronic request, supply a Schedule 6 substance to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, without a written order: Provided that—(i)it shall be the responsibility of such pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person to ensure that such pharmacist receives a written order within seven days;(ii)the Schedule 6 substance shall be supplied in the smallest unit sales pack available;(iii)a permanent record is made and kept of such supply;(k)

in an emergency a pharmacist may sell any Schedule 5 or Schedule 6 substance in a quantity not greater than that required for continuous use for a period of 48 hours, on the verbal instructions of a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, who is known to such pharmacist, but the prescriber who has given such verbal instructions shall within 72 hours after giving such instructions furnish to such pharmacist a written prescription confirming the instructions;(l)

in an emergency a pharmacist may sell a Schedule 2, Schedule 3 or Schedule 4 substance on a non-recurring basis for a period not exceeding 30 days in accordance with the original prescription in order to ensure that therapy is not disrupted if he or she is satisfied that an authorised prescriber initiated the therapy, with the intention that the therapy be continued, and that the particulars of such sale are recorded in a prescription book or other prescribed permanent record;(m)

a pharmacist may sell a greater or a lesser quantity of a Schedule 1, Schedule 2, Schedule 3 or

Schedule 4 substance than the quantity prescribed or ordered, according to the therapeutic pack in the original container of such substance as supplied to him or her, but the quantity so sold shall not exceed or be less than, 25 per cent of the quantity specified in the prescription or order in question;(n)

any seller referred to in this subsection shall retain the prescription or order concerned for a period of not less than five years as from the date of such sale;(o)

a Schedule 6 substance may only be sold if the course of treatment does not exceed 30 consecutive days;(p)

the sale of a specified Schedule 5 or Schedule 6 substance by a manufacturer of or wholesale dealer in pharmaceutical products shall be recorded in a register which shall be kept in the prescribed manner, and shall be balanced so as to show clearly the quantity of every specified Schedule 5 or Schedule 6 substance remaining in stock as on the last day of March, June, September and December of each year, and such balancing shall be completed within the 14 days following each of the said dates;[Para. (p) substituted by s. 5 (a) of Act No. 59 of 2002.]

Wording of Sections

(q)

a pharmacist shall endorse on the prescription the date of sale and the quantity of the substance sold, and when it is repeated, the date of sale and the quantity of the said substance sold, and the last seller shall retain the prescription for a period of not less than five years as from the date of the last sale;(r)

any Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substance for the treatment of any animal may be supplied by any person practising a para-veterinary profession within the meaning of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982), upon a written prescription issued by a veterinarian or on the verbal instructions of a veterinarian.(7) (a) No person, other than a pharmacist, pharmacist intern or pharmacist’s assistant acting under the personal supervision of a pharmacist, shall sell or export a Schedule 1, Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance for analytical purposes, manufacture of foods, cosmetics, educational or scientific purposes, unless a permit, issued in accordance with the prescribed conditions has, subject to paragraph (b), been obtained from the Director-General for such purpose.

(b) The Director-General may revoke any permit referred to in paragraph (a) if the conditions on which such permit was issued, are not complied with or if it is not in the public interest that the particular action be continued.

(8) Subject to subsection (9), a Schedule 8 substance shall not be acquired by any person other than the Director-General for the purpose of providing a medical practitioner therewith,

on the prescribed conditions, for the treatment of a particular patient of that medical practitioner upon such conditions as the Director-General, on the recommendation of the council, may determine.


Wording of Sections

(9) (a) No person shall—(i)acquire, use, possess, manufacture or supply any Schedule 7 or Schedule 8 substance, or manufacture any specified Schedule 5 or Schedule 6 substance unless he or she has been issued with a permit by the Director-General for such acquisition, use, possession, manufacture or supply: Provided that the Director-General may, subject to such conditions as he or she may determine, acquire or authorise the use of any Schedule 7 or Schedule 8 substance in order to provide a medical practitioner, analyst, researcher or veterinarian therewith on the prescribed conditions for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research;[Sub-para. (i) substituted by s. 5 (c) of Act No. 59 of 2002.]

Wording of Sections

(ii)manufacture, use or supply any Schedule 5 or Schedule 6 substance for other than medicinal purposes, unless he or she has been issued by the Director-General with a permit for such manufacture, use or supply upon the prescribed conditions.(b) Notwithstanding paragraph (a), the Director-General may at any time revoke any permit issued in terms of that paragraph if any condition on which the permit was issued is not being complied with.

(c) A permit issued in terms of this subsection shall be valid for a period of 12 calendar months after the date of issue thereof.

(10) Notwithstanding anything to the contrary contained in this section, no person shall sell or administer any Scheduled substance or medicine for other than medicinal purposes: Provided that the Minister may, subject to the conditions or requirements stated in such authority, authorise the administration outside any hospital of any Scheduled substance or medicine for the satisfaction or relief of a habit or craving to the person referred to in such authority.

(11) (a) No person shall import or export any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance or other substance or medicine prescribed for that purpose unless a permit has been issued to him or her by the Director-General in the prescribed manner and subject to such conditions as may be determined by the Director-General.

[Para. (a) substituted by s. 5 (d) of Act No. 59 of 2002.]

Wording of Sections

(b) A permit referred to in paragraph (a) may be issued for any purpose other than the

satisfaction or relief of a habit or craving in respect of such substance or medicine.

(c) The issue of a permit referred to in paragraph (a) may be refused if—

(i)the Director-General is not convinced that the applicant is capable of keeping or storing the substance or medicine in a satisfactory manner in order to prevent the loss thereof;(ii)the use of such substance or medicine has not been authorised in terms of this Act;(iii)the Director-General is of the opinion that the annual importation quota for such substance has been exceeded or will be exceeded;(iv)the Director-General is of the opinion that such substance or medicine, of an acceptable quality, is already available in the Republic; or(v)the applicant did not comply with the conditions under which a previous permit was issued to him or her.(d) If an application is refused, the applicant shall be furnished with the reasons for such refusal.

(e) A permit issued in terms of this subsection shall be valid for a period of six months from the date of issue thereof.

(12) (a) The control on the importation of Scheduled substances shall relate to—

(i)any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance;[Sub-para. (i) substituted by s. 5 (e) of Act No. 59 of 2002.]

Wording of Sections

(ii)such substances irrespective of the scheduling status allocated thereto, as the Minister may prescribe;(iii)any other substance which becomes subject to international control in terms of the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances entered into by the Republic.(b) The obtaining of import or export permits as required in terms of subsection (11) shall not apply to any preparation which contains a substance as prescribed which is specifically exempted from all control measures for the obtaining of such import or export permits by the 1961 Single Convention on Narcotic Drugs referred to in paragraph (a).

[Para. (b) substituted by s. 5 ( f ) of Act No. 59 of 2002.]

Wording of Sections

(c) Notwithstanding paragraph (b), no such importation or exportation shall take place unless authorised by the Director-General.

[Para. (c) substituted by s. 5 (g) of Act No. 59 of 2002.]

Wording of Sections

(13) Any permit issued under subsection (11) shall be subject—

(a)to the applicant’s furnishing the registrar annually with the prescribed information;(b)

to the requirement that there shall be no deviation from the particulars reflected on the permit: Provided that if the quantity of such substance or medicine to be imported is less than that provided for in the permit, the Director-General shall be informed in writing thereof within 10 days after the importation of such substance or medicine; and(c)

to the conditions, as detailed on the permit, having been complied with, the triplicate copy of the permit having been certified by a customs officer or an employee of the S.A. Post Office Limited.(14) Notwithstanding anything to the contrary contained in this section—

(a)

a pharmacist’s assistant shall not handle any specified Schedule 5 or Schedule 6 substance except as contemplated in subsection (5) (a) and (b); and[Para. (a) substituted by s. 5 (h) of Act No. 59 of 2002.]

Wording of Sections

(b)

no nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe a medicine or Scheduled substance unless he or she has been authorised to do so by his or her professional council concerned.(15) Notwithstanding anything to the contrary contained in this section, the Director-General may, after consultation with the Interim Pharmacy Council of South Africa as referred to in section 2 of the Pharmacy Act, 1974 (Act No. 53 of 1974), issue a permit to any person or organisation performing a health service, authorising such person or organisation to acquire, possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance, and such permit shall be subject to such conditions as the Director-General may determine.

(16) Notwithstanding anything to the contrary contained in this section—

(a)

any person may possess a Schedule 0, Schedule 1 or Schedule 2 substance for medicinal purposes;(b)

any person may possess a Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance if he or she is in possession of a prescription issued by an authorised prescriber;[Para. (b) substituted by s. 5 (i) of Act No. 59 of 2002.]

Wording of Sections

(c)

any medicine or scheduled substance may be possessed by a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, or under the Veterinary and Para-Veterinary Professions Act, 1982, for the purposes of administering it in accordance with his or her scope of practice;(d)

any medicine or scheduled substance may be possessed for sale by a pharmacist, a person licenced to own a pharmacy in terms of the Pharmacy Act, 1974, or a person who is the holder of a licence as contemplated in section 22C.(17) For the purposes of this section—

(a)

“authorised prescriber” means a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974; and(b)

“medicinal purpose” means for the purposes of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction or relief of a habit or craving for the substance used or for any other such substance, except where the substance is administered or used in a hospital or similar institution maintained wholly or partly by the Government or a provincial government or approved for such purpose by the Minister.[S. 22A inserted by s. 21 of Act No. 65 of 1974, amended by s. 9 of Act No. 17 of 1979 and by s. 7 of Act No. 71 of 1991, substituted, and subsequently re-substituted (after amendment), by s. 9 of Act No. 94 of 1991 and by s. 13 of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 22A(6)(p) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(8) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(9)(a)(i) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(11)(a) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(12)(a)(i) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(12)(b) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(12)(c) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(14)(a) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A(16)(b) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22A of Act 101 of 1965 prior to amendment by Act 17 of 1979s 22A of Act 101 of 1965 prior to amendment by Act 71 of 1991s 22A of Act 101 of 1965 prior to amendment by Act 94 of 1991s 22A of Act 101 of 1965 prior to amendment by Act 90 of 1997

22B. Publication of information relating to medicine, Scheduled substance or medical device.—(1) Notwithstanding the provisions of section 34 the council may, if it deems it expedient and in the public interest, disclose information in respect of the prescribing, dispensing, administration and use of a medicine, Scheduled substance or medical device.

(2) The Director-General may publish the information referred to in subsection (1) or release it to the public in a manner which he thinks fit.


22C. Licensing.—(1) Subject to the provisions of this section—

(a)

the Director-General may on application in the prescribed manner and on payment of the prescribed fee issue to a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, a licence to compound and dispense medicines, on the prescribed conditions;(b)

the council may, on application in the prescribed manner and on payment of the prescribed fee, issue to a manufacturer, wholesaler or distributor of a medicine or medical device a licence to manufacture, import or export, act as a wholesaler of or distribute, as the case may be, such medicine or medical device, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the council may determine.[Para. (b) substituted by s. 6 (a) of Act No. 59 of 2002.]

Wording of Sections

(2) A licence referred to in subsection shall (1) (a) shall not be issued unless the applicant has successfully completed a supplementary course determined by the South African Pharmacy Council after consultation with the Health Professions Council of South Africa, the Allied Health Professions Council of South Africa and the South African Nursing Council.[Sub-s. (2) substituted by s. 6 (b) of Act No. 59 of 2002.]

Wording of Sections

(3) The Director-General or the council, as the case may be, may require an applicant contemplated in subsection (1) to furnish such information, in addition to any information furnished by the applicant in terms of the said subsection, as the Director-General or the council may deem necessary.

(4) When the Director-General or the council, as the case may be, grants or refuses an application for a licence—

(a)

written notice shall be given of that fact to the applicant; and(b)

in the event of the refusal of an application, the applicant shall be furnished with the reasons for such refusal.(5) No person shall compound or dispense a medicine unless he or she is authorised thereto in terms of the Pharmacy Act, 1974, is a veterinarian or is the holder of a licence as contemplated in subsection (1) (a).

[Sub-s. (5) substituted by s. 6 (c) of Act No. 59 of 2002.]

Wording of Sections

(6) No manufacturer, wholesaler or distributor referred to in subsection (1) (b) shall manufacture, import, export, act as a wholesaler of or distribute, as the case may be, any medicine unless he or she is the holder of a licence contemplated in the said subsection.


Wording of Sections

(7) Subsections (5) and (6) shall come into operation twelve months from the date of commencement of this section.

[S. 22C inserted by s. 14 of Act No. 90 of 1997. Sub-s. (7) substituted by s. 6 (e) of Act No. 59 of 2002.]

Wording of Sections

Wording of Sections s 22C(1)(b) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22C(2) of Act 101 of 1965 prior to amendment by Act 59 of 2002




22D. Period of validity and renewal of licence.—A licence issued under section 22C shall be valid for the prescribed period but may be renewed on application in the prescribed manner and before the prescribed time or such later time as the Director-General or the council, as the case may be, may allow and on payment of the prescribed fee.

[S. 22D inserted by s. 14 of Act No. 90 of 1997.]

22E. Suspension and cancellation of licence.—(1) If the holder of a licence under section 22C—

(a)

has in or in connection with an application for a licence or renewal of a licence furnished the Director-General or the council, as the case may be, with any information which to the knowledge of such holder is untrue or misleading in any material respect;(b)

has contravened or failed to comply with a condition upon which the licence was issued;(c)

has contravened or failed to comply with a provision of this Act;(d)

has, in the case of a licence issued in terms of section 22C (1) (a), at any time been convicted of an offence which is of such a nature that, in the opinion of the Director-General, it renders him or her unsuitable to compound or dispense medicines,the Director-General or the council, as the case may be, may by way of a notice in writing call upon him or her to show cause within the period specified in the notice, which period shall not be less than 20 days as from the date of the notice, why the licence in question should not be suspended or revoked.

(2) The Director-General or the council, as the case may be, may after considering the reasons furnished to him or her in terms of subsection (1)—

(a)

suspend the licence in question for such period as he or she or the council may determine; or

(b)

revoke the licence in question.(3) No person shall be entitled to the repayment of any prescribed fee in respect of any application for the granting or renewal of a licence if such application has been refused or if the licence has been suspended or revoked.

[S. 22E inserted by s. 14 of Act No. 90 of 1997.]

22F. Generic substitution.—(1) Subject to subsections (2), (3) and (4), a pharmacist or a person licensd in terms of section 22C (1) (a) shall—

(a)

inform all members of the public who visit the pharmacy or any other place where dispensing takes place, as the case may be, with a prescription for dispensing, of the benefits of the substitution for a branded medicine by an interchangeable multi-source medicine, and shall, in the case of a substitution, take reasonable steps to inform the person who prescribed the medicine of such substitution; and[Para. (a) substituted by s. 7 (b) of Act No. 59 of 2002.]

Wording of Sections

(b)

dispense an interchangeable multi-source medicine instead of the medicine prescribed by a medical practitioner, dentist, practitioner, nurse or other person registered under the Health Professions Act, 1974, unless expressly forbidden by the patient to do so.[Sub-s. (1) amended by s. 7 (a) of Act No. 59 of 2002.]

Wording of Sections

(2) If a pharmacist is forbidden as contemplated in subsection (1) (b), that fact shall be noted by the pharmacist on the prescription.

(3) When an interchangeable multi-source medicine is dispensed by a pharmacist he or she shall note the brand name or where no such brand name exists, the name of the manufacturer of that interchangeable multi-source medicine in the prescription book.

(4) A pharmacist shall not sell an interchangeable multi-source medicine—

(a)

if the person prescribing the medicine has written in his or her own hand on the prescription the words “no substitution” next to the item prescribed;(b)

if the retail price of the interchangeable multi-source medicine is higher than that of the prescribed medicine; or(c)

where the product has been declared not substitutable by the council.[S. 22F inserted by s. 14 of Act No. 90 of 1997.]

Wording of Sections s 22F(1)(a) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22F(1) of Act 101 of 1965 prior to amendment by Act 59 of 2002

22G. Pricing committee.—(1) The Minister shall appoint, for a period not exceeding five years, such persons as he or she may deem fit to be members of a committee to be known as the pricing committee.


Wording of Sections

(2) The Minister may, on the recommendation of the pricing committee, make regulations—

(a)

on the introduction of a transparent pricing system for all medicines and Scheduled substances sold in the Republic;(b)

on an appropriate dispensing fee to be charged by a pharmacist or by a person licensed in terms of section 22C (1) (a);(c)

on an appropriate fee to be charged by wholesalers or distributors or any other person selling Schedule O medicines.[Para. (c) added by s. 8 (b) of Act No. 59 of 2002.]

(3) (a) The transparent pricing system contemplated in subsection (2) (a) shall include a single exit price which shall be published as prescribed, and such price shall be the only price at which manufacturers shall sell medicines and Scheduled substances to any person other than the State.

(b) No pharmacist or person licensed in terms of section 22C (1) (a) or a wholesaler or distributor shall sell a medicine at a price higher than the price contemplated in paragraph (a).

[Para. (b) substituted by s. 8 (c) of Act No. 59 of 2002.]

Wording of Sections

(c) Paragraph (b) shall not be construed as preventing a pharmacist or person licensed in terms of this Act to charge a dispensing fee as contemplated in subsection (2) (b).

(4) To the members of the pricing committee who are not in the full-time employment of the

State may be paid such remuneration and allowances as the Minister, with the concurrence of the Minister of Finance, may determine.

[S. 22G inserted by s. 14 of Act No. 90 of 1997.]

Wording of Sections s 22G(1) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 22G(3)(b) of Act 101 of 1965 prior to amendment by Act 59 of 2002

22H. Purchase and sale of medicines by wholesalers.—(1) (a) No wholesaler shall purchase medicines from any source other than from the original manufacturer or from the primary importer of the finished product.

(b) A wholesaler shall sell medicines only into the retail sector.

(2) Subsection (1) shall not be construed as preventing the return of medicines for credit purposes only, to the manufacturer or wholesaler from which that medicine was initially obtained.

(3) Any wholesaler may in the prescribed manner and on the prescribed conditions be exempted by the Director-General from the provisions of subsection (1).

[S. 22H inserted by s. 14 of Act No. 90 of 1997.]

23. Disposal of undesirable medicines.—(1) If the council is of the opinion that it is not in the public interest that any medicine shall be made available to the public, it may—

(a)

by notice in writing transmitted by registered post to any person direct that person; or(b)

by notice in the Gazette direct any person,to return any quantity of such medicine which he has in his possession to the manufacturer thereof or (in the case of any imported medicine) to the importer concerned or to deliver or send it to any other person designated by the council.


Wording of Sections

(2) The council may by notice in writing direct any manufacturer or importer of any such medicine who has in his possession any quantity thereof (including any quantity returned, delivered or sent to him in pursuance of a direction under subsection (1)), or any other person to whom any quantity of such medicine has been so returned, delivered or sent, to deal with or dispose of that quantity in such manner as the council may determine.


Wording of Sections

(3) No person shall sell any medicine which is the subject of a notice under subsection (1) which has not been set aside on appeal.


Wording of Sections




24. Appeal against decision of council or Director-General.—(1) Any person aggrieved by a decision of the council may, within the prescribed period, in the prescribed manner and upon payment of the prescribed fee, appeal against such decision to an appeal committee appointed by the Minister for the purposes of the appeal concerned.


Wording of Sections

(2) An appeal committee contemplated in subsection (1) shall consist of no fewer than three persons: Provided that—

(a)

the chairperson shall be appointed on account of his or her knowledge of the law;[Para. (a) substituted by s. 9 (c) of Act No. 59 of 2002.]

Wording of Sections

(b)

the skills of the other two members shall be relevant to the case concerned;(c)

no member shall have a direct or indirect interest in the affairs of the appellant or respondent.(3) The appeal committee may after hearing the appeal—

(a)

confirm, set aside or vary the relevant decision of the council; and(b)direct the council to execute the decision of the appeal committee.


Wording of Sections

(4) The decision of the appeal committee shall be in writing and a copy thereof shall be furnished to the appellant as well as to the council.

[Sub-s. (4) substituted by s. 9 (e) of Act No. 59 of 2002.]

Wording of Sections

(5) To the members of the appeal committee who are not in the full-time employment of the State shall be paid such remuneration and allowances as the Minister, with the concurrence of the Minister of Finance, may determine.

(6) Any person aggrieved by the decision of the Director-General may within the prescribed period and in the prescribed manner make written representations with regard to such decision to the Minister.

[Sub-s. (6) substituted by s. 9 ( f ) of Act No. 59 of 2002.]

Wording of Sections

(7) The Minister shall, after considering representations made in terms of subsection (6), confirm, set aside or vary the decision of the Director-General.

[S. 24 amended by s. 23 of Act No. 65 of 1974, substituted by s. 11 of Act No. 94 of 1991 and by s. 15 of Act No. 90 of 1997 and amended by s. 9 (a) of Act No. 59 of 2002. Sub-s. (7) added by s. 9 (g) of Act No. 59 of 2002.]

Wording of Sections







s 24 of Act 101 of 1965 prior to amendment by Act 90 of 1997s 24 of Act 101 of 1965 prior to amendment by Act 59 of 2002

25. Privileges of council and committees.—The council or a committee appointed under section 9 (1), 22G (1) or 24 (1) or any member of the council or of any such committee shall not be liable in respect of anything done in good faith under this Act.

[S. 25 substituted by s. 32 of Act No. 88 of 1996 and by s. 10 of Act No. 59 of 2002.]

Wording of Sections


26. Inspectors.—(1) The Director-General may authorize such persons as inspectors, as he may consider necessary for the proper enforcement of this Act.


Wording of Sections

(2) Every inspector shall be furnished with a certificate signed by the Director-General and stating that he has been authorized as an inspector under this Act.


Wording of Sections

(3) An inspector shall, before he exercises or performs any power or function under this Act, produce and exhibit to any person affected hereby, the certificate referred to in subsection (2).

[S. 26 substituted by s. 24 (1) of Act No. 65 of 1974.]

Wording of Sections




27. Analysts, pharmacologists and pathologists.—The Director-General may grant such authority to such analysts, pharmacologists and pathologists as he may consider necessary for the proper enforcement of this Act.

[S. 27 substituted by s. 25 (1) of Act No. 65 of 1974 and by s. 11 of Act No. 17 of 1979.]

Wording of Sections


28. Powers of inspectors.—(1) An inspector may, at all reasonable times—

(a)

enter upon—(i)any place or premises from which—(aa)

a person authorized under this Act to compound or dispense medicines or scheduled substances;(bb)

the holder of a licence as contemplated in section 22C (1) (b);(cc)

the holder of a certificate of registration of a medicine,conducts business;

(ii)any place, premises, vessel or aircraft if he or she suspects on reasonable grounds that an offence in terms of this Act has been or is being committed thereon or therein or that an attempt has been made or is being made to commit such an offence thereon or therein; or(iii)any private dwelling, with the consent of the occupier or under the authority of a warrant issued in terms of subsection (5) or without a warrant in terms of subsection (6);(b)

inspect any medicine or scheduled substance, any book, record or documents that the inspector believes on reasonable grounds contains any information relevant to the administration or enforcement of this Act;(c)

seize any book record, documents or medicine or scheduled substance or take so many samples of any such medicine or scheduled substance as he or she may consider necessary for the purpose of testing, examination or analysis in terms of this Act.[Sub-s. (1) amended by s. 26 (a) of Act No. 65 of 1974 and by s. 16 of Act No. 90 of 1997 and substituted by s. 11 (a) of Act No. 59 of 2002.]

Wording of Sections

(2) Any sample taken in terms of paragraph (d) of subsection (1) shall be taken in accordance with the prescribed methods and in the presence of the person who is in charge of

such medicine or Scheduled substance, or if there is no such person or if he is absent for any reason, in the presence of any other witness, shall forthwith be packed and sealed and suitably labelled or marked in such manner as its nature may permit and shall then be transmitted to an analyst, pharmacologist or pathologist together with a certificate in the prescribed forms signed by such inspector and a copy of the aforesaid certificate shall be handed or transmitted by registered post to the owner or seller of such medicine or Scheduled substance or his agent.

[Sub-s. (2) amended by s. 26 (a) of Act No. 65 of 1974 and substituted by s. 12 (a) of Act No. 17 of 1979.]

Wording of Sections

(3) The analyst, pharmacologist or pathologist to whom a sample has been transmitted in terms of the provisions of subsection (2) shall with all convenient speed test, examine or analyse the sample delivered to him, and the result of the test, examination or analysis shall be stated in a certificate in the prescribed form.


Wording of Sections

(4) The owner of the medicine or Scheduled substance from which the sample was taken may claim from the Director-General an amount equal to the market value thereof.


Wording of Sections

(5) Where on a application to a magistrate in appears to such magistrate from information on oath that there are reasonable grounds to believe that—

(a)

the conditions for entry described in subsection (1) (a) exist in relation to a private dwelling:(b)

entry to that private dwelling is necessary for any purpose relating to the administration or enforcement of this Act; and(c)

entry to the private dwelling has been refused or that entry thereto will be refused,a magistrate may issue a warrant authorizing the inspector named therein to enter that private dwelling subject to such conditions as may be specified in the warrant.

[Sub-s. (5) added by s. 11 (b) of Act No. 59 of 2002.](6) If an inspector believes on reasonable grounds that—

(a)

a warrant would be issued to him or her under subsection (5) if he or she applies for such a warrant; and(b)

a delay in obtaining such warrant would defeat the object of the entry, search and seizure,he or she may without a warrant enter and search any premises for any medicines, scheduled substance, book, record or document relevant to the administration or enforcement of this Act and seize or take samples as contemplated in subsection (1) (c).

[Sub-s. (6) added by s. 11 (b) of Act No. 59 of 2002.]





29. Offences.—Any person who—

(a)

obstructs or hinders any inspector in the exercise of his or her powers or the performance of his or her duties under this Act; or[Para. (a) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

(b)

contravenes or fails to comply with the provisions of section 14 (1), 18, 18A or 18B; or[Para. (b) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

(c)

contravenes the provisions of section 19 (1) or fails to comply with a notice issued under section 19 (2); or[Para. (c) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

(d)

contravenes the provisions of section 20 (1); or[Para. (d) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

(e)

contravenes or fails to comply with any condition imposed under section 15 (7); or[Para. (e) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

( f )

fails to comply with any direction given under section 23 or contravenes the provisions of section 23 (3); or[Para. ( f ) substituted by s. 17 (a) of Act No. 90 of 1997.]

Wording of Sections

(g)

with fraudulent intent tampers with any sample taken in terms of this Act; or(h)

makes any false or misleading statement in connection with any medicine or Scheduled substance—(i)in an application for the registration thereof; or(ii)in the course of the sale thereof; or[Para. (h) substituted by s. 27 (a) of Act No. 65 of 1974.]

Wording of Sections

(i)

sells any medicine or Scheduled substance upon the container of which a false or misleading statement in connection with the contents is written; or[Para. (i) substituted by s. 27 (b) of Act No. 65 of 1974.]

Wording of Sections

( j)

for purposes of business or trade makes use of any report or certificate made or issued by an inspector, analyst, pharmacologist or pathologist under this Act; or

(k)

contravenes any provision of section 22A, 22C (5) and (6), 22F, 22G or 22H or contravenes or fails to comply with any condition imposed thereunder;[Para. (k) added by s. 27 (d) of Act No. 65 of 1974 and substituted by s. 17 (b) of Act No. 90 of 1997.]

Wording of Sections

(l)

contravenes or fails to comply with the provisions of section 34;[Para. (l) added by s. 12 of Act No. 94 of 1991.]

(m)

manufactures, sells or uses a veterinary medicine in contravention of a prohibition referred to in section 36A, or contravenes, or fails to comply with, a condition imposed in terms of the said section,[Para. (m) added by s. 12 of Act No. 94 of 1991.]

shall be guilty of an offence.

Wording of Sections s 29(a) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(b) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(c) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(d) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(e) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(f) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 29(h) of Act 101 of 1965 prior to amendment by Act 65 of 1974 Wording of Sections s 29(i) of Act 101 of 1965 prior to amendment by Act 65 of 1974

Wording of Sections s 29(k) of Act 101 of 1965 prior to amendment by Act 90 of 1997

30. Penalties.—(1) Any person who is convicted of an offence referred to in section 29

shall be liable to a fine, or to imprisonment for a period not exceeding 10 years.

[Sub-s. (1) substituted by s. 13 of Act No. 94 of 1991 and by s. 18 (a) of Act No. 90 of 1997.]

Wording of Sections

(2) The court convicting any person of an offence under this Act may, upon the application of the prosecutor, declare any medicine or Scheduled substance in respect of which the offence has been committed to be forfeited to the State.

[Sub-s. (2) amended by s. 28 (a) of Act No. 65 of 1974.]

Wording of Sections

(3) Any medicine or Scheduled substance forfeited under this Act shall be destroyed or otherwise dealt with as the Director-General may direct.


Wording of Sections

(4) Notwithstanding anything to the contrary in any law contained, a magistrate’s court shall be competent to impose any penalty provided for in this section.

[Sub-s. (4) added by s. 18 (b) of Act No. 90 of 1997.]




31. Procedure and evidence.—(1) In any criminal proceedings under this Act—

(a)

any quantity of a medicine or Scheduled substance in or upon any premises, place, vehicle, vessel or aircraft at the time a sample thereof is taken pursuant to the provisions of this Act shall, unless the contrary is proved, be deemed to possess the same properties as such sample;[Para. (a) amended by s. 29 of Act No. 65 of 1974.]

Wording of Sections

(b)

. . . . . .

[Para. (b) deleted by s. 19 (a) of Act No. 90 of 1997.]

Wording of Sections

(c)

a certificate stating the result of a test, examination or analysis carried out in terms of the provisions of section twenty-eight and purporting to be signed by the analyst, pharmacologist or pathologist who carried out such test, examination or analysis, shall be accepted as prima facie proof of the facts stated therein;(d)

any statement or entry contained in any book, record or document kept by any owner of a medicine or Scheduled substance, or by the manager, agent or employee of such owner or found upon or in any premises occupied by, or any vehicle used in the business of, such owner, shall be admissible in evidence against him as an admission of the facts set forth in that statement or entry, unless it is proved that that statement or entry was not made by such owner, or by any manager, agent or employee of such owner in the course of his work as manager, or in the course of his agency or employment.[Para. (d) amended by s. 29 of Act No. 65 of 1974.]

Wording of Sections

(2) . . . . . .

[Sub-s. (2) substituted by s. 13 of Act No. 17 of 1979 and deleted by s. 19 (b) of Act No. 90 of 1997.]

Wording of Sections

(3) The court in which any such certificate is adduced in evidence may in its discretion cause the person who signed such certificate to be summoned to give oral evidence in the proceedings in question or may cause written interrogatories to be submitted to him for reply, and such interrogatories and any reply thereto, purporting to be a reply from such person, shall be admissible in evidence in such proceedings.


Wording of Sections s 31(1)(b) of Act 101 of 1965 prior to amendment by Act 90 of 1997 Wording of Sections s 31(1)(d) of Act 101 of 1965 prior to amendment by Act 65 of 1974


32. . . . . . .

[S. 32 amended by s. 30 of Act No. 65 of 1974 (English only) and repealed by s. 20 of Act No. 90 of 1997.]

Wording of Sections


33. Act or omission by manager, agent or employee.—(1) Whenever any manager, agent or employee of any person (hereinafter called the employer) does or omits to do any act which it would be an offence under this Act for the employer to do or omit to do, then unless it is proved that—

(a)

in doing or omitting to do that act the manager, agent or employee was acting without the connivance or the permission of the employer; and(b)

all reasonable steps were taken by the employer to prevent any act or omission of the kind in question; and(c)

it was not under any condition or in any circumstances within the scope of the authority or in the course of the employment of the manager, agent or employee to do or to omit to do acts, whether lawful or unlawful, of the character of the act or omission charged,the employer shall be presumed himself to have done or omitted to do that act and shall be liable to be convicted and sentenced in respect thereof; and the fact that he issued instructions forbidding any act or omission of the kind in question shall not, of itself, be accepted as sufficient proof that he took all reasonable steps to prevent the act or omission.

(2) Whenever any manager, agent or employee of any such employer does or omits to do an act which it would be an offence under this Act for the employer to do or omit to do, he shall be liable to be convicted and sentenced in respect thereof as if he were the employer.

(3) Any such manager, agent or employee may be so convicted and sentenced in addition to the employer.

33A. Funds of council.—(1) The funds of the council shall consist of—(a)

State funds received through the Department of Health;(b)

fees raised and interest on overdue fees;(c)

money accruing to the council from any other source.(2) (a) The council may accept money or other goods donated or bequeathed to the council,

provided no condition is attached to such donation or bequest.

(b) Details of any such donation or bequest shall be specified in the relevant annual report of the council.

(3) The council shall utilise its funds for the defrayal of expenses incurred by the council in the performance of its functions under this Act.

(4) The council shall open an account with a bank as defined in section 1 (1) of the Banks Act, 1990 (Act No. 94 of 1990), and shall deposit in that account all money referred to in subsections (1) and (2).

(5) The council shall keep full and proper records of all money received or expended, of its assets and liabilities and of its financial transactions.

(6) The records and annual financial statements referred to in subsection (5), shall be audited by the Auditor-General.

(7) The council may invest money which is deposited in terms of subsection (4) and which is not required for immediate use in any manner as it may deem fit.

(8) Any money which at the close of the council’s financial year stands to the credit of the council in the account referred to in subsection (4) and money which has been invested in terms of subsection (7), shall be carried forward to the next financial year as a credit in the account of the council.


34. Preservation of secrecy.—No person shall, except for the purpose of the exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings under this Act, or when required to do so by any competent court or under any law, or with the written authority of the Director-General, disclose to any other person any information acquired by him in the exercise of his powers or the performance of his functions under this Act and relating to the business or affairs of any person, or use such information for self-gain or for the benefit of his employer.


Wording of SectionsWording of Sections s 34 of Act 101 of 1965 prior to amendment by Act 94 of 1991

34A. Delegation of powers.—(1) The Minister may in writing authorise the Director-General or any officer of the Department of Health to exercise any of the powers conferred upon the Minister by this Act other than the powers referred to in sections 3, 24 (1) and 35, or to exercise or perform any of the duties or functions conferred or imposed on the Minister in terms of this Act.


Wording of Sections

(2) The Director-General may in writing authorize any officer of the Department of Health to exercise or perform in general or in a particular case or in cases of a particular nature, any power, duty or function, excluding any power, duty or function referred to in subsection (1), conferred or imposed on the Director-General by or in terms of this Act.

[S. 34A inserted by s. 2 of Act No. 19 of 1976, substituted by s. 15 of Act No. 94 of 1991. Sub-s. (2) amended by s. 22 (b) of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 34A(1) of Act 101 of 1965 prior to amendment by Act 90 of 1997

Wording of Sections s 34A of Act 101 of 1965 prior to amendment by Act 94 of 1991s 34A(2) of Act 101 of 1965 prior to amendment by Act 90 of 1997

35. Regulations.—(1) The Minister may, in consultation with the council, make regulations—

(i)prescribing the categories of persons by whom application may be made for the registration of any medicine or to whom a certificate of registration may be transferred;(ii)prescribing the forms which shall be used for any application for the registration of any medicine and the particulars which shall be furnished with any such application (including particulars regarding the method by which the medicine in question or any component of such medicine is manufactured and the premises at which such medicine or any such component is manufactured);(iii)providing for the classification of medicines into classes or categories for the purposes of this Act;(iv)prescribing the samples of any medicine and the quantity thereof which shall accompany any application for the registration of a medicine;(v)prescribing the form in which the medicines register shall be kept and the particulars which shall be entered therein in respect of any registered medicine;(vi)prescribing the form of any certificate of registration of any medicine;(vii)prescribing the circumstances in which, the conditions on which and the persons or categories of persons to whom any medicine or Scheduled substance may be sold;(viii)prescribing the manner in which any package containing any medicine or Scheduled substance shall be labelled, packed or sealed;(ix)prescribing the particulars in regard to the use thereof which shall be furnished with any

medicine or Scheduled substance sold, and the manner in which such particulars shall be furnished;(x)prescribing the particulars which shall appear in any advertisement relating to any medicine or Scheduled substance, or prohibiting the inclusion of any specified particulars in such advertisement, or the distribution of any such advertisement to a specified person or a specified category of persons or to a specified organisation or a specified category of organisations;(xi)prescribing the requirements with which any medicine or any component thereof shall comply in regard to composition, therapeutic suitability and effect, purity or any other property;(xii)prescribing the particulars which shall be published in the Gazette in respect of any application for registration referred to in section 15 (11);(xiii)prescribing the procedure at meetings of the council and of any committee appointed under section 9 (including the quorum in the case of committees) and the manner in which meetings of any such committee shall be called;(xiv)prescribing the particulars which shall appear on a prescription or an order for a medicine or a Scheduled substance, the number of issues of a medicine or a Scheduled substance that may be made on any such specified prescription or order, the manner in which any such prescription or order shall be issued and the period for which any such prescription or order shall be retained;(xv)prescribing the forms of licences, registers, prescription books, records and other documents which shall be kept or used in respect of Scheduled substances, the manner in which they shall be kept, the particulars which shall be entered therein and the place where and the period for which they shall be retained;(xvi)requiring the furnishing of returns, reports and information in respect of Scheduled substances and plants from which any such substance can be extracted, derived, produced or manufactured, and in respect of any medicine or other substance of which any such Scheduled substance is a component;(xvii)as to the transshipment or the exportation from or importation into the Republic of any Scheduled substance, specifying the ports or places at which such substance may be brought into the Republic;(xviii)authorising and regulating or restricting the transmission through the Republic of Scheduled substances;(xix)prescribing the manner in which packages containing Scheduled substances shall be labelled when imported into or manufactured in the Republic and the persons by whom and the manner in which they shall be kept;(xx)authorising and regulating the purchase, acquisition, keeping or use of preparations of cocaine by managers or persons in charge of factories or workshops in connection with the treatment of eye injuries or for other essential purposes;

(xxi)authorising and regulating the purchase, acquisition, keeping or use of Scheduled substances by particular persons or categories of persons;(xxii)authorising and regulating the possession by persons entering or departing from the Republic of specified quantities of Scheduled substances for personal medicinal use;(xxiii)as to the disposal or destruction of a medicine or a Scheduled substance, and the records which shall be kept in respect thereof;(xxiv)as to the importation, exportation, conveyance, keeping, storage, processing and packing of medicines and Scheduled substances, and the manner in which medicines and Scheduled substances shall be kept and controlled in different categories of hospitals;[Para. (xxiv) substituted by s. 12 (a) of Act No. 59 of 2002.]

Wording of Sections

(xxv)prescribing the methods in accordance with which samples may be taken under this Act and the form of the certificates to be issued by inspectors in respect of such samples;(xxvi)prescribing the methods to be employed and the form of the certificates to be issued in connection with the testing, examination or analysis of samples taken under this Act;(xxvii)authorising, regulating, controlling, restricting or prohibiting the registration, manufacture, modification, importation, exportation, storage, transportation, sale or use of any medical device or class of medical devices or medicines in respect of its safety, quality and efficacy;[Para. (xxvii) substituted by s. 12 (b) of Act No. 59 of 2002.]

Wording of Sections

(xxviii)with regard to any matter to ensure the safety, quality and efficacy of medicines and medical devices;(xxix)as to the summary seizure and disposal of any Scheduled substance found in the possession or custody of any person not entitled under this Act to keep or use it;(xxx)as to the disposal or destruction of a Scheduled substance which has become unfit for use, and the report to be furnished in respect thereof;(xxxi)prescribing the fee to be paid to the registrar in respect of an application for the registration, and in respect of the registration of a medicine, Scheduled substance or medical device, the fee to be paid annually to the registrar in respect of the retention of the registration of a medicine, Scheduled substance or medical device and the date on which such annual fee shall be paid;(xxxii)prescribing the fee payable in respect of the authorisation of the use of unregistered medicines, the issuing of permits and certificates under this Act, the issuing or renewal of any licence under this Act, the performance of inspections to assess the quality of medicines,

Scheduled substances or medical devices for the purpose of registration and the evaluation of changes to the particulars contained in registers;(xxxiii)relating to appeals against decisions of the Director-General or the council;(xxxiv)relating to the conditions under which medicines or Scheduled substances may be sold;(xxxv)relating to the repackaging of medicines in patient-ready packs;(xxxvi)relating to the safety, quality and efficacy of any interchangeable multi-source medicine;(xxxvii)relating to the scientific, pharmaceutical, clinical and other skills required by a member of the council or by a member of the executive committee of the council to evaluate the quality, efficacy and safety of medicines;(xxxviii)relating to the safety, quality and efficacy of imported medicines;(xxxix)relating to the control and conduct of clinical trials;(xl)with regard to any matter which in terms of this Act shall or may be prescribed; and(xli)generally for the efficient carrying out of the objects and purposes of this Act, and the generality of this provision shall not be limited by the preceding paragraphs of this subsection.(2) The Minister shall, not less than three months before any regulation is made under subsection (1), cause the text of such regulation to be published in the Gazette, together with a notice declaring his or her intention to make that regulation and inviting interested persons to furnish him or her with any comments thereon or any representations they may wish to make in regard thereto.

(3) The provisions of subsection (2) shall not apply in respect of—

(a)

any regulation which, after the provisions of that subsection have been complied with, has been amended by the Minister in consequence of comments or representations received by him or her in pursuance of the notice issued thereunder; or(b)

any regulation in respect of which the Minister is, after consultation with the council, of the opinion that the public interest requires it to be made without delay.(4) A regulation under subsection (1) (xxxi) and (xxxii) shall be made only in consultation with the Minister of Finance.

(5) Regulations made under subsection (1) (xi) may prescribe that any medicine or any component thereof shall comply with the requirements set out in any publication which in the opinion of the council is generally recognised as authoritative.

(6) Regulations may be made under this section in respect of particular medicines or Scheduled substances or classes or categories of medicines or Scheduled substances or in

respect of medicines or Scheduled substances other than particular classes or categories of medicines or Scheduled substances, and different regulations may be so made in respect of different medicines or Scheduled substances or different classes or categories of medicines or Scheduled substances.

(7) (a) Regulations made under this section may prescribe penalties for any contravention thereof or failure to comply therewith of a fine, or imprisonment for a period not exceeding 10 years.

(b) Notwithstanding anything to the contrary in any law contained a magistrate’s court shall be competent to impose any penalty provided for in paragraph (a).

(8) Notwithstanding the provisions of subsection (1), the Minister may, if he or she deems it to be in the public interest, after consultation with the executive committee appointed under section 9, make regulations relating to any matter referred to in subsection (1) or amend or repeal any regulation made in terms of that subsection.

[S. 35 amended by s. 5 of Act No. 29 of 1968, by s. 1 of Act No. 88 of 1970 and by s. 7 of Act No. 95 of 1971, substituted by s. 31 (1) of Act No. 65 of 1974, amended by s. 3 of Act No. 19 of 1976, by s. 14 of Act No. 17 of 1979, by s. 7 of Act No. 20 of 1981, by s. 7 of Act No. 71 of 1991 and by s. 16 of Act No. 94 of 1991 and substituted by s. 23 of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 35(1)(xxiv) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 35(1)(xxvii) of Act 101 of 1965 prior to amendment by Act 59 of 2002

Wording of Sections s 35 of Act 101 of 1965 prior to amendment by Act 29 of 1968s 35 of Act 101 of 1965 prior to amendment by Act 88 of 1970s 35 of Act 101 of 1965 prior to amendment by Act 95 of 1971s 35 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 35 of Act 101 of 1965 prior to amendment by Act 19 of 1976s 35 of Act 101 of 1965 prior to amendment by Act 17 of 1979s 35 of Act 101 of 1965 prior to amendment by Act 20 of 1981s 35 of Act 101 of 1965 prior to amendment by Act 71 of 1991s 35 of Act 101 of 1965 prior to amendment by Act 94 of 1991s 35 of Act 101 of 1965 prior to amendment by Act 90 of 1997

36. Exclusion of any drug from operation of Act.—The Minister may, on the unanimous recommendation of the members present at any meeting of the council, by notice in the Gazette exclude, subject to such conditions as he may determine, any medicine from the operation of any or all the provisions of this Act, and may in like manner amend or withdraw any such notice.

[S. 36 amended by s. 32 of Act No. 65 of 1974 (English only).]

Wording of Sections


36A. Minister may prohibit the manufacture, sale or use of certain veterinary medicines.—Notwithstanding anything to the contrary in this Act or in any other law contained, the Minister may by notice in the Gazette for any reason other than the safety, quality or therapeutic efficacy of a veterinary medicine—

(a)

prohibit the manufacture, sale or use of any veterinary medicine containing a substance mentioned in the notice; or(b)

prohibit such manufacture, sale or use, except in accordance with such conditions as may be specified in the notice,and may in like manner repeal or amend such notice.


37. . . . . . .

[S. 37 substituted by s. 33 of Act No. 65 of 1974 and by s. 18 of Act No. 94 of 1991 and repealed by s. 24 of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 37 of Act 101 of 1965 prior to amendment by Act 65 of 1974s 37 of Act 101 of 1965 prior to amendment by Act 94 of 1991s 37 of Act 101 of 1965 prior to amendment by Act 90 of 1997

37A. Amendment of Schedules.—Notwithstanding the provisions of section 35 (2), the Minister may, on the recommendation of the council, from time to time by notice in the Gazette amend any Schedule prescribed under section 22A (2) by the inclusion therein or the deletion therefrom of any medicine or other substance, or in any other manner.

[S. 37A inserted by s. 34 of Act No. 65 of 1974, repealed, and subsequently re-inserted (after amendment), by s. 19 of Act No. 94 of 1991 and substituted by s. 25 of Act No. 90 of 1997.]

Wording of Sections

Wording of Sections s 37A of Act 101 of 1965 prior to amendment by Act 90 of 1997

38. Operation of Act in relation to other laws.—The provisions of this Act shall be in addition to and not in substitution for any other law which is not in conflict with or

inconsistent with this Act.

39. State bound.—This Act binds the State.

[S. 39 repealed by s. 20 of Act No. 94 of 1991 and inserted by s. 26 of Act No. 90 of 1997.]

Wording of Sections

(Date of commencement: 1 July, 2005.)


40. Short title.—This Act shall be called the Medicines and Related Substances Act, 1965.

[S. 40 substituted by s. 35 of Act No. 65 of 1974 and by s. 28 of Act No. 90 of 1997.]

Wording of Sections


Schedule 0

[Schedule 0 inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

(a)

All substances referred to in this Schedule are excluded when specifically packed, labelled, sold and used for—(i)industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, and which are intended to be ingested by man or animals as a food or applied to the body as a cosmetic, and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) or that are registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947); and(ii)analytical laboratory purposes.(b)

This Schedule shall include all substances or mixtures of such substances containing or purporting to contain substances referred to, including the salts and esters of such substances, where the existence of such salts and esters is possible, except where such substances or mixtures of substances are expressly excluded.This Schedule includes all substances or mixtures of substances subject to registration in

terms of the Act and which are not listed in any of the other Schedules.

Schedule 1

[Schedule 1 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.278 of 25 February, 1977, No. R.437 of 1 April, 1977, No. R.1194 of 1 July, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.2416 of 12 November, 1982 and No. R.1289 of 14 June, 1985 (as amended by Government Notice No. 155 of 31 January, 1986), substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.2841 of 7 December, 1990, No. R.2169 of 6 September, 1991, No. R.348 of 5 March, 1993 and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1556 of 16 September, 1994, by Government Notice No. R.673 of 12 May, 1995, by Government Notice No. R.42 of 19 January, 1996, by Government Notice No. R.1496 of 13 September, 1996, by Government Notice No. R.1098 of 15 August, 1997, by Government Notice No. R.1099 of 15 August, 1997, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, amended by Government Notice No. R.491 in Government Gazette 31010 of 25 April, 2008, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)

All substances referred to in this Schedule are excluded when specifically packed, labelled, sold and used for—(i)industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose; and(ii)analytical laboratory purposes.(b)

This Schedule shall include all preparations of substances or mixtures of such substances containing or purporting to contain any substance referred to in this Schedule and includes the following:(i)The salts and esters of such substances, where the existence of such salts and esters is possible; and(ii)all preparations and mixtures of such substances where such preparations and mixtures are not expressly excluded.(c)

In terms of section 22A (4) (a) (v) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 1 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.Acetanilide and alkyl acetanilides.

Acetarsol, when intended for human vaginal use.

Acyclovir, when intended for application to the lips in the early treatment of recurrent herpes simplex virus infections. (S4)

Anethole trithione.

Anticoagulants, when intended for application to the skin. (S4)

Antimony potassium tartrate and antimony sodium tartrate; in concentrations of 1 percent or more. (S0)

Any compound structurally derived from either beta-aminopropylbenzene or beta-aminoisopropylbenzene by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure); and presented as:

(a)

preparations and mixtures when used as vasoconstrictors and decongestants in antihistamine- containing nose and eye preparations; and(b)

appliances for inhalation in which the substance is adsorbed onto solid material but excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine. (S2, S6, S7)Arsenic; in concentrations equivalent to 0,01 percent or less of arsenic trioxide. (S2)

Azelaic acid.

Bacitracin, when intended for topical application to the epidermis, nares and external ear. (S4)

Bee venom, preparations intended for application to the skin. (S4)

Belladonna alkaloids, when specifically intended for topical application. (S2)

Benzethonium chloride, when intended for human vaginal use.

Benzydamine; preparations and mixtures containing—

(a)

3 percent or less of benzydamine, when intended for application to the skin (S3); or(b)

0,15 percent or less of benzydamine, when intended for use as a mouth rinse or for topical application in the mouth and throat; provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day. (S3)Bifonazole, when intended for application to the skin. (S4)

Bioallethrin.

Bitolterol.

Blood collection bags, when intended for the collection and preservation of blood for subsequent use.

Bufexamac, when intended for application to the skin. (S3)

Bunamidine.

Butoconazole,

(a)

when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis (S4) or(b)

when intended for application to the skin. (S4)Chlorhexidine, when intended for human vaginal use. (S0)

Chloroform, preparations and mixtures containing less than 20 percent of chloroform. (S5)

Clotrimazole,

(a)when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis: (S4) and(b)

when intended for application to the skin. (S4)Deanol and its derivatives, unless listed in another Schedule, when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972, (Act 54 of 1972) and for analytical laboratory purposes. (S5)

Diclofenac, when intended for application to the skin. (S2, S3)

Diosmine.

Dithiazanine.

Econazole,

(a)

when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) or(b)

when intended for application to the skin. (S4)Enilconazole, when intended for application to the skin. (S4)

Ephedra alkaloids (natural or synthetic), unless listed separately in the Schedules, intended for application to skin, eyes, ears and nares and containing 1 percent or less of ephedra alkaloids, and not intended for export. (S2, S6)

Ephedrine, preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 percent or less of ephedrine, and not intended for export. (S2, S6)

Escin (aescin); medicinal preparations and mixtures thereof intended for application to the skin and containing 1 percent or less of escin. (S3)

Ether (diethyl ether); in concentrations of less than 20 percent. (S5)

Ethylphenylephrine.

Etofenamate, when intended for application to the skin. (S3)

Felbinac, when intended for application to the skin. (S3)

Fenbendazole, except when registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Fenticonazole, when intended for application to the skin. (S3)

Flubendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Flufenamic acid, when intended for application to the skin. (S3)

Flurbiprofen,

(a)

in the form of lozenges, indicated for the relief of pain associated with sore throats, subject

to:(i)a maximum of 8,75 milligrams per lozenge,(ii)a maximum treatment period of 3 days, and(iii)a maximum pack size of 15 lozenges (S2, S3, S4)(b)

when intended for application to the skin, provided that in the case of application by transdermal patch—(i)use is restricted to adults and children 12 years and older, and(ii)the treatment period is limited to a maximum of 4 weeks. (S2, S3, S4)Fluorescein, when intended for ophthalmic use by the topical route only. (S3)

Fluorides,

(a)

oral medicinal preparations or mixtures intended for ingestion containing 0,25 milligrams or less of fluorine per dosage unit; (S0, S4)(b)

excluding toothpaste containing less than 0,15 percent fluoride; (S0) and(c)

excluding mouth rinses containing less than 0,15 percent fluoride. (S0)Glycosaminoglycan polysulphate (previously mucopolysaccharide poly-sulphuric acid ester) when intended for application to the skin. (S4)

Glycosaminoglycan polysulphate (previously mucopolysaccharide poly-sulphuric acid ester) when intended for application to the skin. (S4)

Gramicidin, when intended for topical application to the epidermis, nares and external ear. (S4)

O-(ß-hydroxyethyl) rutosides.

Hyaluronic acid and its salts, when intended for topical application to the skin. (S0, S2, S4)

Icodextrin.

Ibuprofen, when contained in preparations intended for application to the skin. (S2, S3, S4)

Idoxuridine, when intended for application to the skin. (S4)

Indanazoline.

Indometacin, when intended for application to the skin. (S2, S3)

Irrigation fluids, being sterile fluids intended for irrigation of wounds or hollow visci.

Isoconazole, when intended for

(a)

human vaginal use specifically for the treatment of recurrent vaginal candidiasis (S4); and(b)

application to the skin. (S4)Ketoconazole, when intended for

(a)

application to the skin,(b)

except preparations and mixtures containing not more than 1,0 percent of ketoconazole, when intended for the prevention and treatment of dandruff. (S0, S4)Ketoprofen, when intended for application to the skin. (S2, S3)

Lactobacillus acidophilus and Lactobacillus bifidus, when intended for therapeutic purposes, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Local anaesthetics, except

(a)

when intended for ophthalmic or parental use; (S4)(b)

oxybuprocaine, proxymetacaine and tetracaine, when contained in eye drops intended for emergency treatment of "arc eyes"; (S2) and(c)

ophthalmic preparations registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Lufenuron, except when intended and registered as a systemic preparation against fleas in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Luxabendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Lysozyme, when intended for application to the skin. (S4)

Malathion, except when intended and registered as an ectoparasiticide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Manganese salts, preparations thereof for injection, when intended for veterinary use.

Mebendazole, except when registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Methenamine (hexamine), when intended for application to the skin, (S4)

Methionine.

Miconazole,

(a)

when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and(b)

when intended for application to the skin. (S4)(c)

except for topical treatment of fungal infections of the mouth. (S2)Microfibrillar collagen hydrochloride.

Morantel except when registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

N-acetyl-aspartyl-glutamic acid.Naphazoline, when intended for nasal use. (S2)

Naproxen, when intended for application to the skin. (S2, S3)

Nicotine, when intended for human medicinal use, except when used for the relief of nicotine withdrawal symptoms as an aid to smoking cessation and presented in the following formulations—

(a)

nicotine gum pieces,(i)containing less than 4 milligrams nicotine per piece, and(ii)in packs containing not more than 30 pieces per pack; (S0), and(b)

nicotine transdermal patches, intended for continuous application to the skin in strengths up to and including 15 milligrams/16 hours. (S2)Nitrofurantoin, when intended for application to the skin. (S4)

Nitrofurazone, when intended for application to the skin. (S4)

Normal Saline (Sodium chloride 0.9 % m/v) when intended for injection, in a dosage form not exceeding 20 millilitres in volume. (S0, S3)

Nystatin,

(a)

when intended for application to the skin, and(b)

when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, and(c)

except when presented as oral drops containing not more than 100 000 I.U. per ml. (S2)(d)

except when intended for systemic use or the initial treatment of vaginal candidiasis. (S4)Ornidazole, when intended for application to the skin. (S4)

Orthodichlorobenzene, when intended for topical human medicinal use.

Oxibendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Oxymetazoline, when intended for nasal use. (S2)

Pancreatin.

Paracetamol, except—

(a)

immediate release tablets or capsules each containing 500 milligrams or less of paracetamol, or in individually wrapped powders or in sachets containing 1 000 milligrams or less of paracetamol, subject to—(i)a maximum of 12,5 grams of paracetamol per primary pack, and(ii)in the case of tablets or capsules, presented in blister strip packaging or in containers with child-resistant closures; and(iii)labelled with the following boxed warning, placed prominently on at least the main panel of

the immediate container label and outer label (carton):“CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; (S0)

(b)

in liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres or in paediatric drops containing 120 milligrams or less of paracetamol per 1,2 millilitres, subject to—(i)a maximum of 100 millilitres per primary pack in the case of the liquid or syrup dosage form containing 120 milligrams or less of paracetamol per 5 millilitres;(ii)a maximum of 20 millilitres per primary pack in the case of the paediatric drops;(iii)labelled with the following boxed warning, placed prominently on at least the main panel of the immediate container label and outer label (carton):“CONTAINS PARACETAMOL - READ THE PACKAGE INSERT”; {S0)

(c)

when contained in rectal suppositories. (S2)(d)

when contained in modified release formulations. (S2)(e)

when intended for injection. (S3)Paradichlorobenzene, when intended for topical human medicinal use.

Penciclovir, when intended for application to the lips in the early treatment of recurrent herpes simplex virus infections. (S4)Pentosan polysulfate sodium, except when intended for the treatment of interstitial cystitis. (S3)

Phenylephrine, except ophthalmic preparations containing 0,2 percent or less. (S0)

Phospholipids, when applied for therapeutic purposes.

Polymixin B, when intended for topical application to the epidermis, nares or external ear. (S4)

Procaine, when intended for oral administration.

Propentofylline, when intended for veterinary use. (S4)

Propylhexedrine, when used as a vasoconstrictor and decongestant in nose preparations and inhalants. (S4)

Proteolytic (fibrinolytic) enzymes,

(a)

for oral use and(b)

when intended for application to the skin, and(c)

except when intended for soft contact lens cleaners; (S0) and(d)

except when intended for injection. (S4)Pyrantel pamoate, including veterinary use, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). Correct

Pyridoxilate.

Sertaconazole, when intended for application to the skin. (S4)

Terbinafine, when intended for application to the skin. (S4)

Tetrahydrozoline, when intended for nasal use. (S2)

Thiabendazole, when intended for application to the skin. (S4)

Thiram, except when intended and registered as a fungicide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Ticlatone, when intended for application to the skin.

Tioconazole,

(a)

when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; and(b)

when intended for application to the skin. (S4)Tolmetin, when intended for application to the skin. (S3)

Tyrothricin when intended for topical application to the epidermis, nares and external ear. (S4)

L-tryptophan,

(a)

when intended for medicinal use in dosages of less than 5mg/kg/day or(b)

intended as supplementation for nutritional purposes. (S5)Water for Injection in a dosage form not exceeding 20 milliliters in volume. (S3)

Xylometazoline, when intended for nasal use. (S2)

Zinc salts, when intended for veterinary use as an injection, except

(a)

when intended for oral ingestion, where the daily dose is less than 50 milligrams of elemental zinc, or when intended for topical use by humans; (S0), or(b)

when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Wording of Sections sch 1 of Act 101 of 1965 prior to amendment by GN 155 of 31sch 1 of Act 101 of 1965 prior to amendment by GN 225 of 17sch 1 of Act 101 of 1965 prior to amendment by Act 90 of 1997

Schedule 2

[Schedule 2 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.278 of 25 February, 1977, No. R.437 of 1 April, 1977, No. R.1988 of 30 September, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.2507 of 9 November, 1979, No. R.2416 of 12 November, 1982, No. R.1289 of 14 June, 1985 (as amended by Government Notice No. 155 of 31 January, 1986) and No. 154 of 31 January, 1986, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.1132 of 2 June, 1989, No. R.1862 of 10 August, 1990, No. R.2841 of 7 December, 1990, No. R.2169 of 6 September, 1991, No. R.141 of 5 February, 1993 and No. R.775 of 7 May 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notices Nos. R.1556 and R.1557 of 16 September, 1994, by Government Notice No. R.673 of 12 May, 1995, by Government Notice No. R.1496 of 13 September 1996, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R509 in Government Gazette 24727 of 20 April, 2003, amended by Government Notice No. R.491 in Government Gazette 31010 of 25 April, 2008, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)



In terms of section 22A(5) ( f ) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within their scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 2 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.Acetylcysteine, except when intended for injection. (S3)

Acetyldihydrocodeine:(a)

oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodiene (calculated as base) per dosage unit; and(b)

liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodeine (calculated as base) per 5 millilitre dosage unit. (S6)Aconite alkaloids, preparations containing 0,02 percent or more. (S0)

Acrivastine.

Adrenaline (epinephrine), except–

(a)

ophthalmic preparations when intended for glaucoma, and(b)

preparations for injection. (S3, S4)Alkaloids and glycosides, all poisonous alkaloids and glycosides, and the salts of such poisonous alkaloids and glycosides, when not specifically named in any other Schedule.

Alverin.

Aminopentamide.

Amorolfine.

Amyl nitrite.

Antihistamines, except–

(a)

astemizole and terfenadine; (S4)(b)

when listed separately in these Schedules. (S5)Antimicrobial substances, namely

(a)

griseofulvin, mupirocin, natamycin when intended for application to the skin, nares and external ear; (S4)(b)

nystatin preparations intended for application to the oral cavity, nares and external ear. (S1, S4)Apomorphine; except when indicated for the treatment of erectile dysfunction. (S4)

Aptocaine.

Arecoline.

Arsenic; preparations containing the equivalent of 0,01 percent or more of arsenic trioxide. (S1)

Atropine; except ophthalmic preparations and injections. (S3, S4)

Azatadine

Azelastine.

Bambuterol.

Bamipine.

BCG vaccine – see Mycobacterium bovis.

Beclomethasone, when intended for nasal administration (other than by aerosol), in the treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12, subject to a maximum dose equivalent to 100 micrograms of beclomethasone diproprionate per nostril, a maximum daily dose equivalent to 200 micrograms of beclomethasone diproprionate per nostril and a maximum of 200 doses per pack. (S3, S4)

Belladonna alkaloids, except when intended for topical application. (S1)

Benproperine.

Bevonium methylsulphate.

Bismuth, when intended for oral use.

Bromhexine.

Bromides, preparations containing less than 80 milligrams of bromine per recommended daily dose. (S5)

Brompheniramine

Buclizine.

Butinoline.

Calabar bean alkaloids.Camphorated Opium Tincture.

Camylofin.

Cantharidin.

Canthaxanthin

Carbinoxamine.

Carbocisteine.

Carbuterol, except

(a)

when contained in respirator solutions; (S3) and(b)

when intended for injection. (S4)Carisoprodol.

Cetirizine.

Chlormezanone; preparations containing not more than 100 milligrams per recommended dose. (S5)

Chlorodyne (as described by Chloroform and Morphine Tincture BP 1980); preparations containing 5,0 percent or less of chlorodyne in combination with other active medicinal ingredients. (S6)

Chloroguine, when used in combination with proguanil and when intended specifically for malaria prophylaxis. (S4)

Chlorpheniramine.

Chlorprenaline.

Cholestyramine.

Chlorzoxazone.

Clonidine when intended for the treatment of migraine. (S3)

Cimetidine, when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum daily dose of 800 milligrams and a maximum treatment period of 2 weeks. (S3)

Cinnarizine.Clemastine.

Clemizole.

Clidinium bromide.

Codeine (methylmorphine),

(a)

oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of codeine (calculated as base) per dosage unit; or(b)

liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of codeine (calculated as base) per 5 millilitre dosage unit. (S6)Colchicine, when intended for the emergency treatment of acute gout, subject to a maximum total treatment course of 6 milligrams. (S3)

Cyclandelate.

Cyclizine.

Cyclopentolate, except when intended for ophthalmic administration. (S3)

Cyproheptadine, when indicated for allergic rhinitis or antipruritic use. (S5)

Desloratidine.

Dexchlorpheniramine.

Dextromethorphan.

Diclofenac, for a maximum period of 5 days when intended for

(a)

the emergency treatment of acute gout attacks, or(b)

the treatment of post traumatic conditions. (S1, S3)Dicyclomine.

Diphenoxin (or diphenoxylic acid), mixtures containing, per dosage unit, 0,5 milligrams or less of difenoxin, calculated as the base, and a quantity of atropine sulphate equal to at least 5 percent of such quantity of difenoxin, calculated as the base, as is present in the mixture. (S6)

Diphenoxylate preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit. (S6)

Diphtheria toxoid vaccine.

Dihydrocodeine,

(a)

oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of dihydrocodeine (calculated as base) per dosage unit; (S6) or(b)

liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of dihydrocodeine (calculated as base) per 5 milliliters dosage unit. (S6)Dimethindene.

Dimethothiazine.

Dimetindene.

Diphenhydramine.

Diphenylpyraline.

{D-norpseudoephedrine - see cathine (S6)}

Doxylamine.

Ebastine.

Emedastine.

Emepronium.

Emetine, substances, preparations and mixtures containing less than 0,2 percent of alkaloids, calculated as emetine. (S4)

Ephedra alkaloids (natural or synthetic), contained in products registered in terms of the Act, and not intended for export, unless listed separately in the Schedules:

(a)

oral preparations and mixtures containing not more than 30 milligrams of ephedra alkaloids per dose, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer; (S6)(b)

except when intended for application to skin, eyes, ears and nares and containing 1 percent or less of ephedra alkaloids. (S1)Ephedrine, contained in products registered in terms of the Act, and not intended for export,

(a)

oral preparations and mixtures containing not more than 30 milligrams of ephedrine per dose, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer; (S6)(b)

except preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 percent or less of ephedrine. (S1)Epinastine.

Ergot alkaloids (natural or synthetic), when intended for the treatment of migraine. (S4)

Ethylmorphine:

(a)

oral solid preparations, in combination with one or more therapeutically active substances,

and containing 20 milligrams or less of ethylmorphine (calculated as base) per dosage unit; (S6) and(b)

liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per 5 milliliters dosage unit. (S6)Etilefrine.

Etodroxizine, preparations and mixtures when used solely as an antihistamine. (S5)

Exalamide.

Famotidine, when intended for the short-term symptomatic relief of heartburn caused by excess acid, subject to–

(a)

a maximum dose of 10 milligrams;(b)

a maximum daily dose (per 24 hours) of 20 milligrams;(c)

a maximum treatment period of 2 weeks. (S4)Fedrilate.

Fenoprofen,

(a)

when intended for the emergency treatment of acute gout attacks, and(b)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S3)Fenoterol, except

(a)


when intended for injection or for the prevention or delay of labour. (S4)Fexofenadine.

Flavoxate.

Flunarizine.

Flunisolide, when intended for nasal administration, other than by aerosol in a strength not exceeding 0,025 percent (m/v), indicated for treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12, subject to-

(a)

a maximum dose of 50 micrograms per nostril and a maximum daily dose of 100 micrograms per nostril in the case of adults and children over the age of 16 years;(b)

a maximum dose of 25 micrograms per nostril and a maximum daily dose of 75 micrograms per nostril in the case of children 12 to 16 years of age; and(c)

a pack size containing not more than 240 doses. (S3, S4)Flurbiprofen, when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days. (S1,S3,S4)

Fluticasone propionate, when intended for nasal administration (other than by aerosol), in the short-term (less than 6 months) prophylaxis and treatment of symptoms of allergic rhinitis (hay fever) in adults and children over 12, subject to a maximum daily dose of 100 micrograms per nostril and a maximum pack size limit of 120 doses. (S3)

Fusafungine.

Gadopentetic acid.

Gamma benzene hexachloride when intended to be used for the second line treatment of lice in a pack size not exceeding 60ml. (S4)

Gelsemium alkaloids.

Glycopyrronium.

Griseofulvin, when intended for application to the skin, nares and external ear. (S4)

Halogenated hydroxyquinolines, when intended for application to the skin. (S4)

Haemophilus influenzae vaccine (Hib).

Hepatitis B vaccine

Hexametazine.

Hexoprenaline–

(a)

except when contained in respirator solutions; (S3) and(b)

except when intended for injection or for the prevention or delay of labour. (S4)Homatropine; preparations and mixtures thereof, except ophthalmic preparations. (S3)

Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action unless listed elsewhere in the Schedules,

(a)

when intended for human vaginal use, and(b)

when specifically intended for emergency postcoital contraception. (S3, S4, S5)Hyaluronic acid and its salts when intended for ophthalmic use in preparations (except injectables) containing 0,1 percent or less; (S0, S1, S4)

Hydrocortisone and hydrocortisone acetate, when used in

(a)

maximum concentration of 1 percent in preparations intended for application to the skin, and(b)in a maximum concentration of 1 percent used in combination with miconazole for topical application in the treatment of athlete’s foot. (S4)Hydroquinone; preparations and mixtures containing 2 percent or less thereof, when intended for application to the skin. (S3)

Hyoscine; substances, preparations and mixtures thereof, including transdermal preparations when intended for the prevention of the symptoms of motion sickness.

Ibuprofen when used in oral medicinal preparations—

(a)

when intended for the treatment of post-traumatic conditions for a maximum treatment period of 5 days, where the recommended daily dose for adults does not exceed 1,2 g and the dose for children up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S3)(b)

for the emergency treatment of acute gout attacks; (S3)(c)

except when intended for the treatment of a haemodynamically significant patent ductus arterious in infants less than 34 weeks of gestational age. (S4)Indometacin, when intended for the emergency treatment of acute gout attacks. (S1, S3)

Influenza vaccine.

Iopromide.

Ipratropium, when contained in respirator solutions. (S3)

Isoaminile.

Isoprenaline (isoproterenol), except

(a)


when intended for injection. (S4)Isopropamide.

Isothipendyl.

Ketoprofen,

(a)

when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 75 milligrams of ketoprofen in 24 hours;(b)

when intended for the emergency treatment of acute gout attacks;(c)

when intended for the treatment of post-traumatic conditions, subject to a maximum dose of 100 milligrams of ketoprofen per day, for a maximum treatment period of 5 days. (S1, S3)Lansoprazole, when intended for the temporary short-term relief of heartburn and hyperacidity, subject to—

(a)

maximum daily dose of 15 milligrams(b)

maximum treatment period of 14 days. (S4)Levocabastine.

Levocetirizine.

Lithium salts, when intended for application to the skin. (S5)

Local anaesthetics,

(a)

except when intended for ophthalmic and parental use; (S4)(b)

oxybuprocaine, proxymetacaine and tetracaine, when contained in eye drops intended for emergency treatment of "arc eyes".Lobelia alkaloids.

Lodoxamide.

Loperamide.

Loratadine.

Measles vaccine

Mebeverine.

Mebhydrolin.

Meclozine.

Mefenamic acid,

(a)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days; and(b)

preparations containing mefenamic acid as the only therapeutically active substance, when intended for the treatment of primary dysmenorrhoea, subject to a maximum daily dose of 500 millligrams 3 times a day and a maximum treatment period of 3 days. (S3)Mepenzolate bromide.

Mephenesin.

Mepyramine.

Mequitazine.

Mercuric ammonium chloride.

Mercuric chloride.

Mercuric iodide.

Mercuric oxides, substances, preparations and mixtures thereof, containing less than 3 per cent of mercury. (S4)

Mercury organic compounds

(a)

substances, preparations and mixtures in the form of aerosols, intended for application to the skin and mucous membranes and substances,(b)

preparations and mixtures containing the equivalent of 0,6 percent or more of elemental mercury, intended for application to the skin and mucous membranes,(c)

except phenylmercuric nitrate when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Mesna, except preparations intended for injection. (S4)

Metaproterenol (orciprenaline), except

(a)when contained in respirator solutions; (S3) and(b)

when intended for injection. (S4)(c)

when intended for the prevention or delay of labour, (S4)Methixene.

Methocarbamol.

Metholilazine.

Methoxyphenamine.

Metronidazole, when intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis and except when intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947). (S4)

Miconazole, when intended for human use in preparations containing 2 percent or less of miconazole, for the topical treatment of fungal infections of the mouth (oral candidiasis). (S1, S4)

Minoxidil, when intended for application to the scalp in preparations containing not more than 2 percent (m/v) and which are registered in terms of the Act. (S4)

Mizolastine.

Morphine; mixtures containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S6)

Mumps vaccine.

Mupirocin, when intended for application to the skin, nares and external ear. (S4)

Mycobacterium bovis vaccine (BCG).

Nabumetone, when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S3)

Naphazoline, except when intended for nasal use. (S1)

Naproxen,

(a)

as the sodium salt, when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, at a maximum dose of 600 milligrams naproxen (660 milligrams naproxen sodium) in 24 hours; and(b)

when intended for the emergency treatment of acute gout attacks; and(c)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S1, S3)Natamycin, when intended for application to the skin, nares and external ear. (S4)

Nedocromil.

Nicergoline.

Nicotine when intended for human medicinal use, except–

(a)

nicotine gum containing 4 milligrams or less nicotine per piece where the pack size does not exceed 30 pieces per pack when these medicines are used for the relief of nicotine withdrawal symptoms as an aid to smoking cessation only; (S0)(b)

nicotine transdermal patches for continuous application to the skin in strengths up to and including 15 milligrams/16 hours when these medicines are used for the relief of nicotine withdrawal symptoms as an aid to smoking cessation only. (S1)Nizatidine, when administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to–

(a)


a maximum daily dose of 300 milligrams;(c)

a maximum treatment period of two weeks. (S4)Norcodeine,

(a)

oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of norcodeine (calculated as base) per dosage unit; (S6) or(b)

liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of norcodeine (calculated as base) per 5 millilitre dosage unit. (S6){(+)-norpseudoephedrine - see cathine (S6)}

Noscapine.

Nux vomica; substances, preparations and mixtures thereof, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Nystatin,

(a)

when presented as oral drops containing not more than 100 000 I.U. per ml, and(b)

except when intended for application to the skin, (S1) and(c)

except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, (S1) and(d)

except when intended for systemic use or the initial treatment of vaginal candidiasis. (S4)Octatropine.

Oleoresin of aspidium (Filix Mas).

Olopatadine.

Opium; mixtures containing not more than 0,2 percent of morphine, calculated as anhydrous

morphine. (S6)

Orphenadrine.

Otilonium bromide.

Oxatomide.

Oxybuprocaine, when contained in eye drops intended for emergency treatment of arc eyes. (S4)

Oxymetazoline, except when intended for nasal use (S1).

Oxyphencyclimine.

Oxyphenonium.

Papaverine; substances, preparations and mixtures thereof.

Pantoprazole, when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:

(a)

maximum daily dose of 20 milligrams(b)

maximum treatment period of 14 days. (S4)Paracetamol,

(a)

when contained in rectal suppositories, or(b)

when contained in modified release formulations. (S0, S1, S3)Pentoxyfylline.

Pertussis toxoid vaccine.

Phenazone (antipyrone).

Phenazopyridine.

Phenindamine.

Pheniramine.

Phenylpropanolamine (norephedrine), preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not

exceed 50 milligrams, when intended for the symptomatic relief of nasal and sinus congestion.

Phenyltoloxamine.

Pholcodine, preparations and mixtures when compounded with one or more therapeutically active substances, and containing 20 milligrams or less of pholcodine (calculated as base) per dosage unit and liquid oral preparations and mixtures and containing 20 milligrams or less of pholcodine (calculated as base) per 5 millilitres dosage unit. (S6)

Pholcodine,

(a)

oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of pholcodine (calculated as base) per dosage unit; (S6) or(b)liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of pholcodine (calculated as base) per 5 milliliters dosage unit. (S6)Pholedrine.

Pimethixene, preparations and mixtures thereof when used solely as an antihistaminic. (S5)

Pinaverium.

Pipenzolate.

Pipoxolan.

Pirbuterol, except when contained in respirator solutions. (S3)

Piroxicam,

(a)

when intended for the emergency treatment of acute gout attacks, and(b)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S3)Pizotifen; preparations and mixtures, when intended for prophylaxis of migraine. (S5)

Pneumococcal vaccine, conjugated.

Podophyllum resin; preparations and mixtures containing 20 percent or less thereof. (S4)

Poldine methylsulphate.

Polio vaccine.

Potassium chloride,

(a)

where the recommended dose is more than 20 millimol of potassium (1 500 milligrams of potassium chloride) per 24 hours, (S0)(b)

except when intended for intravenous infusion or for injection; (S3) and(c)

except when contained in oral rehydration preparations. (S0)Povidone iodine when intended for application to the vagina. (S0)

Prifinium bromide.Procaterol, except when contained in respirator solutions. (S3)

Procyclidine.

Proglumide.

Proguanil, when used in combination with chloroquine and intended specifically for malaria prophylaxis. (S4)

Promethazine,

(a)

when intended for use as an antihistamine, and(b)

when intended for application to the skin, and(c)

when intended specifically for the treatment of travel sickness. (S5)Propantheline bromide.

Propyphenazone.

Proxymetacaine, when contained in eye drops intended for the emergency treatment of arc eyes. (S4)

Pseudoephedrine, contained in products registered in terms of the Act, and not intended for export,

(a)

oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine

per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S6)Pyrobutamine.

Quinine, preparations and mixtures containing not more than 1 percent thereof. (S4)

Ranitidine, when administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to–

(a)


a maximum daily dose of 300 milligrams;(c)

a maximum treatment period of two weeks. (S3)Reproterol, except when contained in respirator solutions. (S3)

Rimiterol, except

(a)

when contained in respirator solutions (S3) and(b)

when intended for injection. (S4)Rotavirus, live attenuated.

Rubella vaccine.

Sabadilla alkaloids; substances, preparations and mixtures containing 1 percent or more thereof.

Salbutamol, except

(a)


when intended for injection. (S4)Salmefamol, except

(a)


when intended for injection. (S4)Siccanin, when intended for application to the skin.

Sodium cromoglycate, except when intended for veterinary use. (S4)

Strychnine, preparations and mixtures containing 0,2 percent or less thereof. (S4)

Sulphadiazine silver when intended for application to the skin in the short-term treatment of minor burns, provided that the pack size is limited to a maximum of 50 grams. (S4)

Sulphonamides when intended for application to the eyes, nares and vagina; (S4)

Terbutaline, except when contained in respirator solutions. (S3)

Tetanus vaccine.

Tetracaine, when contained in eye drops intended for emergency treatment of arc eyes. (S4)

Tetrahydrozoline, except when intended for nasal use. (S1)

Thenalidine.

Thenyldiamine.

Theophylline and its derivatives, unless listed in another Schedule, and except in preparations for injection. (S4)

Thiethylperazine.

Tiaprofenic acid, when intended for the treatment of post-traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days. (S3)

Timepidium.

Triamcinolone, when intended for application to oral lesions. (S4)

Trimebutine.

Trimeprazine (Alimemazine).

Tripelennamine.

Triprolidine.

Trospium.

Tulobuterol, except when contained in respirator solutions. (S3)

Typhoid vaccine.

Xylometazoline, except when intended for nasal use. (S1)

Wording of Sections sch 2 of Act 101 of 1965 prior to amendment by GN 155 of 31sch 2 of Act 101 of 1965 prior to amendment by GN 225 of 17sch 2 of Act 101 of 1965 prior to amendment by Act 90 of 1997

Schedule 3

[Schedule 3 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.278 of 25 February, 1977, No. R.437 of 1 April, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.2507 of 9 November, 1979, No. R.658 of 27 March, 1981, No. R.1289 of 14 June, 1985 and No. 154 of 31 January, 1986, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.2841 of 7 December, 1990, No. R.2169 of 6 September, 1991, and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1556 of 16 September, 1994, by Government Notice No. R.673 of 12 May, 1995, by Government Notice No. R.42 of 19 January, 1996, by Government Notice No. R.1496 of 13 September, 1996, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R. 1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)


This Schedule shall include all preparations of substances or mixtures of such substances containing or purporting to contain any substance referred to in this Schedule and includes the following:(i)The salts and esters of such substances, where the existence of such salts and esters is possible; and(ii)all preparations and mixtures of such substances where such preparations and mixtures are

not expressly excluded.(c)

In terms of section 22A(5) ( f ) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 3 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.Acamprosate.

Acebutolol.

Aceclofenac.

Acetazolamide.

Acetohexamide.

Acetylcholine, when intended for ophthalmic use.

Acetylcysteine, when intended for injection. (S2)

Acipimox.

Adapalene.

Adrenaline (epinephrine); ophthalmic preparations thereof, when intended for glaucoma. (S2, S4)

Alclofenac.

Alendronic acid.

Aliskiren

Allopurinol.

Alprenolol.

Amiloride.

Amlodipine.

Ancrod.

Anthiolimine, when intended for injection.

Arsanilic acid.

Atenolol.

Atropine; ophthalmic preparations. (S2, S4)

Azapropazone.

Balsalazide.

Barnidipine.

Beclamide.

Beclomethasone - see corticosteroids.

Benazepril.

Bendazac.

Benfluorex.

Benoxaprofen.

Benzbromarone.

Benzydamine, except preparations and mixtures containing–

(a)

3 percent or less of benzydamine when intended for application to the skin (S1);(b)

0,15 percent or less of benzydamine when intended for use as a mouthrinse or for topical application in the mouth and throat: Provided that the total dose swallowed does not exceeds 36 milligrams of benzydamine per day. (S1)Bepridil.

Beta-benzalbutyramide.

Beta-galactosidase, when intended for therapeutic purposes.

Betahistine.

Betaxolol.

Bethanidine.

Bevantolol.

Bezafibrate.

Bisoprolol.

Bopindolol.

Brimonidine.

Brinzolamide.

Budesonide, when intended for inhalation and for nasal administration. (S4)

Bufexamac, except when intended for application to the skin. (S1)Buflomedil.

Buformin.

Bumetanide.

Butecosone, when intended for inhalation and for nasal administration.

Cadralazine.

Calcipotriol.

Calcium carbimide.

Calcium salts, preparations thereof, when intended for injection, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Calcium disodium edetate, when intended for injection.

Calcium dobesilate.

Candesartan.

Captopril.

Carazolol.

Carbachol, ophthalmic preparations thereof when intended for glaucoma. (S4)

Carbamazepine.

Carbenoxolone, except when intended for application to the oral mucosa. (S0)

Carbuterol, when contained in respirator solutions. (S2, S4)

Carprofen.

Carteolol.

Carvedilol.

Celecoxib.

Celiprolol.

Chenodeoxycholic acid.

Chlorazanil.Chlorexolone.

Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide-1,1-dioxide, whether hydrogenated or not, including hydrochlorothiazide, bendrofluazide, benzthiazide, cyclopenthiazide, hydroflumethiazide, metchlorothiazide and polythiazide.

Chlorpropamide.

Chlorthalidone.

Chromonar.

Ciclesonide

Cilazapril.

Cilomilast.

Cimetidine, except when intended for the short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, subject to a maximum unit dose of 200 milligrams, a maximum daily dose (per 24 hours) of 800 milligrams and a maximum treatment period of 2 weeks. (S2)

Clofibrate.

Clonidine, except when intended for the treatment of migraine. (S2)

Clopidogrel.

Colchicine, except when intended for the emergency treatment of acute gout, subject to a maximum total treatment course of 6 milligrams. (S2)

Colestipol.

Copper salts, when intended for injection.

Corticosteroids (natural or synthetic), when contained in preparations intended for inhalation, except–

(a)

beclomethasone dipropionate, when intended for nasal administration, other than by aerosol, indicated for the treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12, subject to a maximum dose per nostril of 100 micrograms, a maximum daily dose per nostril of 200 micrograms and a pack size limited to 200 doses; and(b)

flunisolide, when intended for nasal administration, other than by aerosol, in a strength not exceeding 0,025 per cent (w/v), indicated for treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12, subject to, in the case of adults and children over the age of 16 years, a maximum dose per nostril is 50 micrograms and a maximum daily dose per nostril of 100 micrograms, and in the case of children 12 to 16 years, a maximum dose per nostril of 25 micrograms and a maximum daily dose per nostril of 75 micrograms and a pack size limited to 240 doses; and(c)

fluticasone propionate, when intended for nasal administration, other than by aerosol, in the short-term (less than 6 months) prophylaxis and treatment of symptoms of allergic rhinitis (hay fever) in adults and children over 12, subject to a maximum daily dose per nostril of 100 micrograms and a pack size limited to 120 doses. (S2, S4)Cyclandalate.

Cyclopentolate; ophthalmic preparations thereof. (S2)

Darifenacin.

Debrisoquine.

Delapril.

Dialysate preparations.

Dichlorphenamide.

Diclofenac,

(a)

except when intended for application to the skin; (S1) and(b)

except when intended for the emergency treatment of acute gout attacks; (S2) and(c)

except when intended for the treatment of post traumatic conditions, for a maximum treatment period of 5 days. (S2)Dienogest.

Diflunisal.

Diftalone.

Digitalis, its glycosides and other active principles thereof, unless diluted below one unit (BP) in each 2,0 grams.

Dihydroergocristine.

Dilevalol.

Diltiazem.

Dimercaprol, when intended for injection.

Dipivefrin.

Dipyridamole.

Dipyrocetyl.

Disulfiram.

Dithranol.

Dornase alfa (rh DNase).

Dorzolamide.

Doxazosin.

Eltenac.

Enalapril.

Endralazine.

Eprosartan.

Escin (aescin), except preparations and mixtures thereof intended for application to the skin and containing 1 percent or less of escin. (S1)

Esculin, when intended for oral use.

Esmolol.

Estradiol.

Ethacrynic acid.

Ethambutol.

Ethionamide.

Ethosuximide.

Etisazol.

Etodolac.

Etodolic acid.

Etofenamate, except when intended for application to the skin. (S1)

Etoricoxib.

Exenatide

Felbamate.

Felbinac, except when intended for application to the skin. (S1)

Felodipine.

Fenbufen.

Fenclofenac.

Fendiline.

Fenofibrate.

Fenoprofen,

(a)

except when intended for the emergency treatment of acute gout attacks, (S2) and(b)

when intended for the treatment of post traumatic conditions, for a maximum treatment period of 5 days. (S2)Fenoterol, when contained in respirator solutions. (S2, S4)

Fentiazac.

Fenticonazole, except when intended for application to the skin. (S1)

Firocoxib.

Floctafenine.

Flufenamic acid, except preparations and mixtures intended for application to the skin. (S1)

Fluorescein, except when intended for ophthalmic use by the topical route only. (S1)

Flunisolide – see corticosteroids.

Flunixin.

Flurbiprofen, except–

(a)

when intended for ophthalmic use; (S4)(b)

when intended for application to the skin in adults and children 12 years and older only, including application by transdermal patch, subject to a maximum treatment period of 4 weeks; (S1)(c)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2)(d)

in the form of lozenges, indicated for the relief of pain associated with sore throats, subject to:(i)a maximum treatment period of 3 days, and(ii)a maximum of 8,75 milligrams per lozenge,(iii)a maximum pack size of 15 lozenges (S1)Fluticasone – see corticosteroids.

Fosinopril.

Frusemide.

Gabapentin.

Gadoxetic acid.

Gemfibrozil.

Glafenine.

Glibenclamide.

Glibornuride.

Gliclazide.

Glimepiride.

Glimidine.

Glipizide.

Gliquidone.

Glucosamine, substances, preparations and mixtures when intended for the treatment of primary and secondary osteoarthritis, osteochondrosis and spondylosis, except when registered as a feed supplement in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Guanabenz.

Guanethidine.

Guanfacine.

Guanoxan.

Hexoprenaline, when contained in respirator solutions. (S2, S4)

Homatropine; ophthalmic preparations thereof. (S2)

Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action, unless listed elsewhere in the schedules;

(a)

when intended for oral contraception;(b)

except when intended for human vaginal use (S2), and(c)

except hormones when specifically intended for emergency postcoital contraception. (S2, S4, S5)Hydralazine.

Hydroquinone; preparations and mixtures thereof containing more than 2,0 percent hydroquinone. (S2)

Ibuprofen, except for application to the skin (S1), and except when used in oral medicinal preparations –

(a)

for the treatment of post-traumatic conditions for a maximum treatment period of 5 days,

where the recommended daily dose for adults does not exceed 1,2 g and the dose for children up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)(b)

for the emergency treatment of acute gout attacks; (S2)(c)

for the treatment of a haemodynamically significant patent ductus arterious in infants less than 34 weeks of gestational age. (S4)Indapamide.

Indometacin, except

(a)

for application to the skin (S1), and(b)

for the emergency treatment of acute gout attacks (S2).Indoprofen.

Indoramin.

Injections, unless listed in another Schedule.

Insulin.

Ipratropium, except when contained in respirator solutions. (S2)

Irbesartan.

Iron salts, when intended for injection, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Isoniazid and its derivatives, unless listed in another Schedule.

Isoprenaline (isoproterenol), when contained in respirator solutions. (S2, S4)

Isosorbide.

Isoxicam.

Isradipine.

Ivabradine.

Ivermectin, except when intended and registered as an anthelmintic and/or ectoparasiticide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock

Remedies Act, 1947 (Act 36 of 1947).

Ketanserin.

Ketoprofen, except–(a)

when intended for application to the skin; (S1)(b)

when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, subject to a maximum dose of 75 milligrams of ketoprofen in 24 hours; (S2)(c)

when intended for the emergency treatment of acute gout attacks or for the treatment of post-traumatic conditions, subject to a maximum dose of 75milligrams of ketoprofen per day and a maximum treatment period of 5 days. (S2)Ketorolac trometamol, when intended for ophthalmic use. (S4)

Labetalol.

Lacidipine.

Lumiracoxib.

Lamotrigine.

Lercanidipine.

Levothyroxine.

Levetiracetam.

Levobunolol.

Levosemindan.

Lidoflazine.

Lisinopril.

Lonazolac.

Lornoxicam.

Losartan.

Macrogol (polyethylene glycol), when used for faecal impaction, or for the purposes of bowel

cleansing prior to surgery or diagnostic procedures. (S0)

Meclofenamic acid.

Mefenamic acid, except–

(a)

when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; and(b)

preparations containing mefenamic acid as the only therapeutic active substance, when intended for the treatment of primary dysmenorrhoea subject to a maximum daily dose of 500 millligrams mefenamic acid 3 times a day and a maximum treatment period of 3 days. (S2)Meloxicam.

Mepindolol.

Mesalazine (5-aminosalicylic acid).

Mesulphene.

Metaproterenol (orciprenaline), when contained in respirator solutions. (S2, S4)

Metformin.

Methazolamide.

Methimazole.

Methsuximide.

Methyldopa.

Metipranolol.

Metolazone.

Metoprolol.

Mibefradil.

Moexipril.

Montelukast.

Moxonidine.

Nabumetone, except when intended for the treatment of post-traumatic conditions, for a

maximum treatment period of 5 days. (S2)

Nadolol.Naftidrofuryl.

Naproxen, except-

(a)

when intended for application to the skin; (S1)(b)

the sodium salt, when intended for the short term management of headache, toothache, muscular ache, backache, minor pain associated with arthritis, pain associated with menstrual cramps (dysmenorrhoea), minor aches and pains associated with the common cold and fever, subject to a maximum dose of 600 milligrams naproxen (660 milligrams naproxen sodium) in 24 hours; (S2)(c)

when intended for the emergency treatment of acute gout attacks; (S2)(d)

when intended for the treatment of post traumatic conditions, for a maximum treatment period of 5 days. (S2)Nateglinide.

Nebivolol.

Nicardipine.

Nifedipine.

Niflumic acid.

Nimesulide.

Nimodipine.

Nisoldipine.

Nitrendipine.

Nitroglycerine, when intended for medicinal use.

Normal Saline (Sodium chloride 0.9 % m/v) except for injection in a dosage form not exceeding 20 milliliters in volume. (S1)

Normal Saline (Sodium chloride 0.9 % m/v) when intended for injection, except when intended for injection in a dosage form not exceeding 20 millilitres in volume. (S0, S1)

Olsalazine.

Omesartan.

Orlistat.

Oxaprozin.

Oxcarbazepine.

Oxitracetam.

Oxovinca.

Oxyprenolol.

Oxybutynin.

Parecoxib.

Para-aminosalicylic acid and its esters.

Paracetamol, when intended for injection. (S0, S1, S2)

Parenteral Nutrition formulations.

Penbutolol.

Penicillinase, when intended for injection.

Pentaerythritol tetranitrate.

Pentolinium.

Pentosan polysulfate sodium, when intended for the treatment of interstitial cystitis. (S1)

Perindopril.

Phenformin.

Phenobarbital, preparations and mixtures containing not more than 90 milligrams of phenobarbital per minimum recommended or prescribed dose when intended for continued use in epilepsy. (S5)

Phenoxymethylpenicillin, when intended for the prophylaxis of rheumatic fever. (S4)

Phentolamine.

Phenytoin.

Physostigmine; ophthalmic preparations thereof, when intended for glaucoma. (S4)Pilocarpine; ophthalmic preparations thereof intended for glaucoma. (S4)

Pindolol.

Pioglitazone.

Piracetam.

Pirbuterol, when contained in respirator solutions. (S2)

Piretanide.

Piroxicam,

(a)

except when intended for the emergency treatment of acute gout attacks, (S2) or(b)

when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2)Pirprofen.

Potassium canrenoate.

Potassium chloride, where the recommended dose is more than 20 millimol of potassium (1 500 milligrams of potassium chloride) per 24 hours (S2) or when intended for intravenous infusion or for injection, but except when contained in oral rehydration preparations. (S0)

Practolol.

Prazosin.

Primidone.

Probenecid.

Probucol.

Procaterol, when contained in respirator solutions. (S2)

Proctofene.

Propacetamol.

Propiverine.

Propranolol.

Proquazone.

Proscillaridine.

Prothionamide, when intended for oral use.

Pygeum africanum (lipido-sterolic complex extract thereof).

Pyrazinamide, when intended for oral use.

Pyrimethamine.

Pyrithioxin.

Quinapril.

Racecadotril.

Raloxifene.

Ramipril.

Ranitidine, except where administered orally for short-term symptomatic relief of heartburn and hyperacidity, subject to a maximum dose of 75 milligrams, a maximum daily dose of 300 milligrams and a maximum treatment period of two weeks. (S2)

Raubasine.

Rauwolfia alkaloids.

Repaglinide.

Reproterol, when contained in respirator solutions. (S2)

Reserpine (natural or synthetic).

Rimiterol, when contained in respirator solutions. (S2, S4)

Risedronate.

Rofecoxib.

Rosiglitazone.

Roxarzone (3-nitro-4-hydroxyphenylarsonic acid), when intended for veterinary use.

Salbutamol, when contained in respirator solutions. (S2, S4)

Salmefamol, when contained in respirator solutions. (S2, S4)Solcoseryl; ophthalmic preparations thereof. (S0, S4)

Solifenacin.

Sotalol.

Spirapril.

Spironolactone.

Strontium, except when contained in toothpaste. (S0)

Strophanthus; its glycosides and their hydrolysis products, and their derivatives, unless listed in another Schedule.

Sulindac.

Suloctidil.

Sulphinpyrazone.

Sulthiame.

Suprofen.

Sylimarin.

Tasosartan.

Tazarotene.

Telmisartan.

Tenidap.

Tenoxicam.

Tepoxalin.

Terazosin.

Terbutaline, when contained in respirator solutions. (S2)

Terizidone.

Terodiline.

Thiacetazone.

Thiocolchicoside.

Thyroid gland and its active principles and derivatives, unless listed in another Schedule.

Tiagabine.

Tiaprofenic acid, except when intended for the treatment of post-traumatic conditions, for a maximum treatment period of 5 days. (S2)

Ticlopidine.

Timolol.

Tiotropium

Tolamolol.

Tolazamide.

Tolbutamide.

Tolfenamic acid.

Tolmetin, except when intended for application to the skin. (S1)

Tolterodine.

Topiramate.

Torasemide.

Trandolapril.

Tretinoin, when intended for application to the skin. (S5)

Triamterene.

Tricaine.

Trimethadione.

Tropicamide.

Tulobuterol, when contained in respirator solutions. (S2)

Ursodeoxycholic acid.

Valdecoxib.

Valproic acid and its derivatives, unless listed in another Schedule.

Valsartan.

Vedaprofen.

Verapamil (iproveratril).

Veratrum alkaloids.

Vigabatrin.

Vincamine.

Vinpocetine.

Vitamin A; preparations thereof for injection and oral preparations and mixtures thereof containing more than 10 000 I.U. per recommended daily dose, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Vitamin D; preparations thereof for injection and oral preparations and mixtures thereof containing more than 500 I.U. per recommended daily dose, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Water for injection except in a dosage form not exceeding 20milliliters in volume. (S1)

Xamoterol.

Xipamide.

Zafirlukast.

Zinc salts,

(a)

for oral ingestion, where the daily dose is more than 50 milligrams of elemental zinc; (S0),(b)

except preparations thereof for injection, when intended for veterinary use; (S1) and(c)

except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Zomepirac.

Wording of Sections sch 3 of Act 101 of 1965 prior to amendment by GN 225 of 17sch 3 of Act 101 of 1965 prior to amendment by Act 90 of 1997

Schedule 4

[Schedule 4 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.279 of 25 February, 1977, No. R.437 of 1 April, 1977, No. R.1194 of 1 July, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.658 of 27 March, 1981, No. R.2416 of 12 November, 1982, No. R.1289 of 14 June, 1985 and No. 154 of 31 January, 1986, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.2841 of 7 December, 1990, No. R.2169 of 6 September, 1991, No. R.580 of 21 February, 1992, No. R.141 of 5 February, 1993 and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1556 of 16 September, 1994, by Government Notice No. R.673 of 12 May, 1995, by Government Notice No. R.42 of 19 January, 1996, by Government Notice No. R.1496 of 13 September 1996, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)



In terms of section 22A(5) ( f ) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 4 substances and medicines

provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.Abacavir.

Abatacept

Acarbose.

Acediasulfone.

Acetarsone diethylamine salt, when intended for injection.

Acyclovir, except when intended for application to the lips in the early treatment of recurrent Herpes simplex virus infections. (S1)

Adalimumab.

Adenosine.

Adrenaline, when intended for injection. (S2, S3)

Aglepristone.

Alatrofloxacin.

Albendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Alclometasone.

Alcuronium.

Aldesleukin.

Alefacept.

Alemtuzumab.

Alfuzosin.

Alizapride.

Almitrine.

Alosetron.

Alfacalcidol.

Alphachymotrypsin (a-chymotrypsin), when intended for ophthalmic use.

Alprostadil.

Alteplase (recombinant human tissue-type plasminogen activator) (r-tPA).

Amantadine.

Amifostine.

Amikacin.

Aminoacridine.

Aminoglutethimide.

Aminolevulinic.

Aminophenazone.

Aminopyrine (amidopyrine).

Aminosalicylic acid.

Amiodarone.

Amiphenazole.

Amodiaquine.

Amoxicillin.

Ampicillin except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. (Act 36 of 1947)

Amprolium, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. (Act 36 of 1947)

Amphotericin B

Amprenavir.

Amrinone.

Amsacrine.

Anagrelide.

Anastrozole.

Anecortave.

Anidulafungin.

Anticoagulants, except preparations intended for application to the skin. (S1)

Antihemophilic factor.

Antimalarials, unless listed elsewhere in the Schedules.

Antimicrobial substances, natural or synthetic including substances purporting to be suitable for the treatment of microbial infections unless listed elsewhere in the Schedules, and except—

(a)

the following substances when intended for topical application to the epidermis, nares and external ear:(i)bacitracin; (S1)(ii)gramicidin; (S1)(iii)griseofulvin; (S2)(iv)mupirocin; (S2)(v)natamycin; (S2)(vi)polymyxin B; (S1)(vii)tyrothricin; (S1)(b)

when intended for use as–(i)disinfectants, being topical agents or preparations used to treat inanimate objects, materials or surfaces, and that destroys or inhibits the growth of pathogenic micro-organisms so treated in the non-sporing or vegetative state, rendering them harmful to neither health nor the quality of perishable goods; (S0)(ii)antiseptics, being topical agents or preparations used on skin and other living tissues, and that destroys or inhibits the growth of pathogenic micro-organisms so treated in the non-sporing or vegetative state, protecting health and preventing infection; (S0) and(iii)germicides, being topical agents or preparations used to treat inanimate objects, materials or surfaces and/or on skin and other living tissues, destroying or killing pathogenic micro-organisms so treated in the non-sporing or vegetative state, thereby protecting health, the quality of perishable goods, and preventing infection. (S0)

Antisera, unless listed elsewhere in the Schedules when intended for veterinary use, except antisera registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Apomorphine, when indicated for the treatment of erectile dysfunction. (S2)

Apraclonidine.

Apramycin.

Aprotinin.

Aprepitant.

A-b arteether.

Arabinosylcytosine.

Arprinocid, except when intended and registered as an anticoccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Arsenamide, when intended for injection.

Artemether and its derivatives.

Artemisinin.

Artemotil.

Artesunate.

L-Asparaginase.

Astemizole.

Atazanavir.

Atipamizole.

Atorvastatin.Atosiban.

Atovaquine.

Atracurium besilate.

Atropine injections. (S2, S3)

Auranofin.

Avilamycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Avoparcin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Azacitidine.

Azathioprine.

Azithromycin.

Azlocillin.

Aztreonam.

Baclofen.

Bacitracin, except when intended for topical application to the epidermis, nares and external ear. (S1) and except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Bambermycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Barium sulfate.

Basiliximab.

Bacampicillin.

Bee venom, except preparations intended for application to the skin. (S1)

Bemegride.

Bemiparin.Benethamine penicillin.

Benzathine benzylpenicillin.

Benzathine phenoxymethylpenicillin.

Benzylpenicillin.

Betamethasone.

Bethanechol.

Betiatide.

Bevacizumab.

Bifonazole, except when intended for application to the skin. (S1)

Bimatoprost.

Biological medicines, injectable preparations thereof, when intended for human use and unless listed elsewhere in the Schedules,

(a)

except vaccines, when listed elsewhere in the Schedules and vaccines registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).(b)

but specifically including the following –(i)Equine anti-human thymocyte globulin;(ii)Equine gamma globulin;(iii)Human anti-D immunoglobulin;(iv)Human anti-thymocyte rabbit immunoglobulin;(v)Hepatitis A vaccine;(vi)Hepatitis B immunoglobulin;(vii)Human normal immunoglobulin, possibly polyvalent or possibly including IqG, IqA, or IqM;(viii)Human plasma albumin;(ix)Neiserria meningitides polysaccharide vaccine;(x)Pneumococcal vaccine, polysaccharide;(xi)Rabies immunoglobulin;(xii)Rabies vaccine;(xiii)Recombinant cholera toxin B subunit;(xiv)rhDNase-dornase alfa;(xv)

Tetanus immunoglobulin;(xvi)Varicella immunoglobulin;(xvii)Varicella-zoster virus vaccine;(xviii)Yellow Fever virus, attenuated.Biperiden.

Bleomycin.

Bortezomib.

Bretylium tosilate.

Bromocriptine.

Budesonide, except when intended for inhalation and for nasal administration. (S3)

Bufenoide.

Bumadizone.

Buserelin.

Busulfan.

Butoconazole, except–

(a)

when intended for application to the skin; (S1) and(b)

when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)Cabergoline.

Calcitonin.

Calcitriol.

Calcium polystyrene sulfonate, when intended for therapeutic purposes.

Cambendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Carnidazole, except when listed elsewhere in the Schedules and except injections thereof intended for use in pigeons and registered in terms of the provisions of the Fertilizers, Farm

Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Candicidin.

Capecitabine.

Capreomycin.

Carbachol, except ophthalmic preparations thereof, when intended for glaucoma. (S3)

Carbadox, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Carbenicillin.

Carbetocin.

Carbidopa.

Carboplatin.

Carbuterol, when intended for injection. (S2, S3)

Carmustine.

Capreomycin.

Caspofungin.

Cefaclor.

Cefadroxil.

Cefalexin.

Cefaloridine.Cefalosporin.

Cefalotin.

Cefamandole.

Cefazolin.

Cefepime.

Cefixime.

Cefmetazole.

Cefodizime.

Cefonicid.

Cefoperazone.

Cefotaxime.

Cefotetan.

Cefovecin.

Cefoxitin.

Cefpirome.

Cefpodoxime.

Cefprozil.

Cefradine.

Cefsulodin.

Ceftazidime.

Ceftibuten.

Ceftiofur.

Ceftizoxime.

Ceftobiprole.

Ceftriaxone.Cefuroxime.

Cefalotin.

Cerivastatin.

Ceruletide.

Cetrorelix.

Cetuximab.

Chlorambucil.

Clodantoin.

Chlormadinone.

Chloroquine, except when sold in combination with proguanil for malaria prophylaxis. (S2)

Choriogonadotropin alfa.

Chloramphenicol.

Chlorguinaldol.

Chlortetracycline except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of anaplasmosis, footrot, heartwater, navel ill and pneumonia in sheep and cattle and capsules thereof intended for the use in pigeons and derivatives when intended for topical use in the management of wounds in animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Chymopapain, when intended for injection.

Ciclacillin.

Cilastatin.

Cinacalcet.

Cinoxacin.

Ciplofloxacin.

Ciprofloxacin.

Cisapride.

Cisatracurium.

Cisplatin.

Cladribine.

Clanobutin.

Clarithromycin.

Clavulanic acid.

Clazuril, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Clemizole penicillin.

Clenbuterol.

Clioquinol.

Clindamycin.

Clobetasol.

Clobetasone.

Clofazimine.

Clomifene.

Closantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Clotrimazole, except when intended for application to the skin (S1) and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

Cloxacillin, except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Colfosceril.

Colistin.

Contrast media, unless listed elsewhere in the Schedules.Corticosteroids (natural or synthetic), unless listed elsewhere in the Schedules, except—

(a)

hydrocortisone and hydrocortisone acetate when used as a single active ingredient in a maximum concentration of 1,0 per cent in preparations intended for application to the skin; (S2)(b)

triamcinolone when intended for application to oral lesions; (S2) and(c)

when contained in preparations intended for inhalation. (S2, S3)Co-tetroxazine.

Co-trifamole.

Co-trimoxazole.

Cyclofenil.

Cyclophosphamide and its derivatives, unless listed in another Schedule.

Cycloserine.

Cyclosporin.

Cyprenorphine.

Cyproterone acetate.

Cytarabine.

Dabigatran

Dacarbazine.

Dacliximab.

Daclizumab.

Dactinomycin.

Dalteparin.

Danaparoid.

Danofloxacin.

Dantrolene.

Dapsone and its derivatives, unless listed elsewhere in the Schedules.

Darbepoetin Alfa

Darunavir.

Dasatinib.

Daunorubicin.

Decoquinate, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Deferasirox.

Deferoxamine.

Demecarium.

Demeclocycline.

Desirudin.

Desonide.

Desoximetasone.

Diatrizoic acid.

Diazoxide.

Dichlorophen, except–

(a)

preparations and mixtures when intended for application to the skin; (S0) and(b)

except when intended for use and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Diclazuril, except when intended registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Diclodronic acid.Dicloxacillin.

Didanosine.

Diethylcarbamazine.

Diflorasone.

Difloxacin.

Diflucortolone.

Dihydralazine.

Dihydrostreptomycin except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Dihydrotachysterol.

Diiodohydroxyquinoline, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Di-isopropyl fluorophosphate.

Dilazep.

Diloxanide furoate.

Dimethyl sulphoxide.

Dimetridazole, except when listed elsewhere in the Schedules and except when intended for use in pigeons, as an anti-spirochaete preparation for pigs and to promote growth in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Diminazene, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947.

Dinitolmide, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Dinitrophenol.

Dinoprostone.

Diphemethoxidine.

Difenidol.

Diprenorphine.

Disophenol, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Disopyramide.

Distigmine.

Ditazole.

Dobutamine.

Docetaxel.

Dolasetron.

Domperidone.

Dopa.

Dopamine.

Doxapram.

Doxepin, when intended for application to the skin. (S5)

Doxorubicin.

Doxycycline, except when listed elsewhere in the Schedules and except preparations thereof for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947), excluding when intended for administration in animal feed.

Drotrecognin.

Dutasteride.

Econazole, except–

(a)

when intended for application to the skin (S1) and(b)when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)Enilconazole, except when intended for application to the skin. (S1)

Enramycin, except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Edoxudine.

Edrophonium.

Efalizumab.

Efavirenz.

Eletriptan.

Emetine, except substances, preparations and mixtures containing less than 0,2 percent of

alkaloids, calculated as emetine. (S2)

Emtricitabine

Encainide.

Enoxacin.

Enoxaparin.

Enrofloxacin.

Entacapone.

Entecavir.

Epicillin.

Epinephrine, when intended for injection. (S2, S3)

Epirizole.

Epirubicin (4-epidoxorubicin).

Eplerenone.

Epoetin beta, polyethylene glycol

Ergot alkaloids (natural or synthetic), except preparations and mixtures thereof when intended for the treatment of migraine. (S2)Erlotinib.

Ertapenem.

Erythromycin.

Esomeprazole.

Estramustine.

Etamiyan.

Etanercept.

Etidronic acid.

Etiproston.

Ethopabate, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm

Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Ethambutol.

Ethionamide.

Etofamide.

Etoglucid.

Etoposide.

Everolimus.

Ezetimibe.

Famciclovir.

Famotidine, except when intended for the short term symptomatic relief of heartburn caused by excess acid, where the maximum dose is 10 milligrams, the maximum daily dose (per 24 hours) is 20 milligrams and the maximum treatment period is 2 weeks. (S2)

Fazadinium.

Febantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Fenchlorphos, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Fenoldopam.

Fenoterol, when intended for the prevention or delay of labour, and preparations thereof for injection. (S2, S3)

Fenticonazole.

Fertirelin.

Ferucarbitran.

Filgrastim.

Finasteride.

Flecainide.

Florfenicol.

Flosequinan.

Flucloxacillin.

Fluconazole.

Flucytosine.

Fludarabine.

Flugestone.

Flumethasone.

Flunisolide.

Fluocinolone.

Fluocinonide.

Fluocortolone.

Fluorides, except–

(a)

oral medicinal preparations and mixtures intended for ingestion containing 0,25 milligrams or less of fluorine per dosage unit. (S0, S1)(b)

toothpaste containing less than 0.15 percent fluoride; (S0) and(c)

mouth rinses containing less than 0.15 percent fluoride. (S0)5-Fluorouracil.

Fluprednidene.

Flurbiprofen, when intended for ophthalmic use. (S1, S2, S3)

Flutamide.

Fluticasone.

Fluvastatin.

Fondaparinux.

Formoterol.

Fosamprenavir.

Fosaprepitant.

Fosfomycin.

Fosphenytoin sodium.

Fotemustine.

Framycetin.

Ftorafur.

Fulvestrant.

Furaltadone, except when listed elsewhere in the Schedules and except when intended as a single oral dosage for gastro-intestinal infections and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Furazolidone.

Fusidic acid.

Gadobutrol.

Gadodiamide.

Gadofosveset.

Gadoversetamide.

Galactose, when used as a contrast agent.

Galantamine.

Gallamine.

Gamma benzene hexachloride, except when intended to be used for the second line treatment of lice in a pack size not exceeding 60ml. (S2)

Ganciclovir.

Ganirelix.

Gatifloxacin.

Gefitinib.

Gemcitabine.

Gemtuzumab.

Gemifloxacin.

Gentamicin.

Gestrinone.

Glatiramer.

Glycosaminoglycan polysulfate (previously mucopolysaccharide poly-sulphuric acid ester), except when intended for application to the skin. (S1)

Goserelin.

Gramicidin except when intended for topical application to the epidermis, nares and external ear. (S1)

Granisetron.

Granulocyte Colony Stimulating Factor (G-CSF).

Griseofulvin except when intended for topical application to the epidermis, nares and external ear. (S2)Grepafloxacin.

Halcinonide.

Halofantrine.

Halofenate.

Halofuginone, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Halogenated hydroxyquinolines, except when intended for application to the skin. (S2)

Halometasone.

Halquinol.

Hemin.

Heparin.

Heptaminol.

Hexoprenaline, when intended for the prevention or delay of labour and preparations thereof for injection. (S2, S3)

Histrelin

Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action, unless listed elsewhere in the Schedules, and except–

(a)

when specifically intended for emergency postcoital contraception; (S2)(b)

when intended for oral contraception; (S3)(c)

insulin; (S3)(d)

epinephrine; ( S2, S3, S4)(e)

corticotrophin (adrenocorticotrophic hormone; ACTH); (S5)( f )

Human growth hormone (human somatotropin) - all forms; (S5)(g)

zeranol, natural estrogen, and progesterone, when intended and registered as a veterinary production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).(h)

BST (Bovine somatropin), when intended and registered as a production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Human Papillomavirus vaccine.

Human Plasma.

Hyaluronidase.

Hyaluronic acid and its salts, except in preparations containing less than 2,5 percent when intended for topical use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972), and except

(a)

when intended for use with contact lens solutions or as an ophthalmic lubricant in concentrations of not more than 0,1 percent; (S0)

(b)

when intended for ophthalmic use in preparations (except injectables) containing more than 0,1 percent; (S2)(c)

when intended for topical application to the skin. (S1)Hycanthone.

Hydroxycarbamide. (Hydroxyurea)

Hydroxychloroquine.

Ibandronic acid.

Ibuprofen, when intended for the treatment of a haemodynamically significant patent ductus arterious in infants less than 34 weeks of gestational age. (S1, S2, S3)

Ibutilide.

Ibritumomab.

Idarubicin.

Idoxuridine, except when intended for application to the skin. (S1)

Iloprost.

Imatinib.

Imidocarb, except when intended and registered as an antibabesial for the treatment of babesiosis in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Imiglucerase.

Imiquimod.

Imipenem

Indinavir.

Indium chloride pentetreotide.

Infliximab.

Inosine pranobex.

Interferon alpha.

Interferon beta.

Interferon gamma.

Intra-uterine devices.

Intra-uterine systems, drug eluting, unless listed elsewhere in the Schedules.

Intrifiban.

Isotretinion.

Iobitridol.

Iocarmic acid.

Iodamide sodium.

Iodised oil, when used as a contrast agent.

Iodixanol.

Iofendylate.Ioglicic acid.

Iohexol.

Iomeprol.

Iopamidol.

Iopanoic acid.

Iopromide.

Iotalamate sodium.

Iotrolan.

Ioversol.

Ioxitalamic acid.

Ioxoglate sodium.

Irinotecan.

Isepamicin.

Isoconazole, except when intended for application to the skin and when intended for human

vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

Isoniazid

Isopirin.

Isoprenaline (isoproterenol), when intended for injection. (S2, S3)

Isoxsuprine.

Itraconazole.

Josamycin.

Kanamycin.

Ketoconazole, except—

(a)

preparations and mixtures containing not more than 1,0 per cent of ketoconazole when intended for the prevention and treatment of dandruff; (S0) or(b)

when intended for application to the skin. (S0, S1)Ketorolac trometamol, except when intended for ophthalmic use. (S3)

Lamivudine.

Lanreotide.

Lansoprazole, except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to—

(a)

a maximum daily dose of 15 milligrams (S2); and(b)

a maximum treatment period of 14 days. (S2)Lanthanum.

Lapatinib.

Lasalocid, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Latamoxef.

Latanoprost.

Leflunomide.

Lenograstim.

Lepirudin.

Letrozole.

Levallorphan.

Levamisole, except when intended and registered as an anthelmintic and an immunomodulator in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Levobupivacaine.

Levofloxacin.

Liarozole.Lincomycin.

Linezolid.

Local anaesthetics, when intended for ophthalmic or parenteral use except–

(a)

when intended for topical use; (S1)(b)

oxybuprocaine, proxymetacaine and tetracaine when contained in eye drops intended for emergency treatment of "arc eyes"; (S2).Lomefloxacin.

Lomustine.

Lopinavir.

Loracarbef.

Loteprednol.

Lovastatin.

Lumefantrine.

Lutropin alfa.

Lymecycline.

Lysozyme, except preparations and mixtures when intended for application to the skin. (S1)

Maduramicin, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Mafenide.

Mangafodipir trisodium.

Mandelic acid.

Maraviroc.

Marbofloxacin.

Mecamylamine.

Mecillinam.

Medical gases, when used in combination with nitrous oxide, but excluding such medical gasses when used alone or in combinations that exclude nitrous oxide. (S0)

Mefloquine.

Meglumine diatrizoate.

Meglumine gadobenate.

Meglumine gadoterate.

Meglumine iodipamide.

Meglumine ioglycamate.

Meglumine iotalamate.

Meglumine iotroxate.

Meglumine pentetate.

Melagatran.

Melarsoprol.

Melphalan and its derivatives, unless listed in another Schedule.

Memantine.

Menotrophin

Mepacrine.

Mephentermine.

Mepirizole.

Meropenem.

6-Mercaptopurine and its derivatives, unless listed in another Schedule.

Mercury, preparations and mixtures that contain mercury metal and that are intended for medicinal use, except preparations of mercuric oxides containing less than 3 percent of mercury. (S2)

Mesna, when intended for injection. (S2)

Metaproterenol (orciprenaline), when intended for the prevention or delay of labour, and preparations thereof for injection. (S2, S3)

Metergoline.

Methacholine.

Methampyrone (dipyrone).

Methenamine (hexamine), except when intended for application to the skin. (S1)

Methotrexate.

Methoxsalen.

Methyl-5-aminolevulinate.

Methylnaltrexone.

Methylprednisolone.

Methysergide.

Metoclopramide.

Metomidate.

Metrizoic acid.

Metronidazole except when

(a)

intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947) and(b)

intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis. (S2)Mexiletine.

Mezlocillin.

Miconazole,

(a)

except when intended for application to the skin; (S1) and(b)except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1) and(c)

except when intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis). (S2)Mifepristone.

Miglitol.

Milrinone.

Miltefosine.

Minocycline.

Minoxidil, except when intended for application to the scalp in preparations containing not more than 2 % (w/v) and which are registered in terms of the Act. (S2)

Misoprostol.

Mitomycin C.

Mitoxantrone.

Mivacurium.

Mizolastine.

Mofebutazone.

Molgramostim.

Mometasone.

Monensin except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation and as a feed additive for growth promotion in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Moracizine.

Morazone.

Morinamide promolate.

Morphethylbutyne.

Moxifloxacin.

Mucoglucuronan.

Muromonab.

Mupirocin, except when intended for topical application to the epidermis, nares and external ear. (S2)

Mycophenolic acid.

Nadroparin.

Nalidixic acid.

Nalorphine.

Naloxone.

Naltrexone.

Narasin except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Naratriptan.

Natalizumab.

Natamycin, except when intended for topical application to the epidermis, nares and external ear. (S2)

Nefopam.

Nelfinavir.

Niacin when intended for hypercholesterolaemia.

Neomycin, except when registered in terms of the provisions of the Fertilizers. Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Neostigmine.

Neotizide.

Netilmicin.

Netobimin.

Nevirapine.

Nicarbazin, except when intended and registered as an anti-coccidian preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Nicotinic acid, when intended for the management of dyslipidaemias. (S0)

Nifuratel.

Nifuroxazide.

Nifurtoinol.

Nikethamide.

Nilutamide.

Nimorazole.

Nimustine.

Niridazole.

Nitrofurantoin, except preparations thereof intended for application to the skin. (S1)

Nitrofurazone,except when intended for application to the skin. (S1)

Nitrofural, except preparations thereof intended for application to the skin. (S1)

Nitrous oxide, alone or in combination with other medical gases.

Nitrovin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers,

Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Nitroxoline.

Nitroxynil, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Nizatidine, except when intended for oral administration for short-term symptomatic relief of heartburn and hyperacidity, where the maximum dose is 150 milligrams, the maximum daily dose is 300 milligrams and the maximum treatment period is two weeks. (S2)

Nomegestrol.

Norfloxacin.Novobiocin.

Nystatin,

(a)

when intended for systemic use or the initial treatment of vaginal candidiasis;(b)

except when presented as oral drops containing not more than100 000 I.U. per ml. (S2)(c)

except when intended for application to the skin, (S1) and(d)

except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)Obidoxime.

Octocog alfa.

Octreotide.

Ofloxacin.

Olaquindox, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Oleandomycin.

Omalizumab.

Omeprazole.

Ondansetron.

Oprelvekin.

Ornidazole, except when intended for application to the skin. (S1)

Oseltamivir.

Oxamniquine.

Oxfendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Oxacillin.

Oxaliplatin.

Oxolinic acid.

Oxybuprocaine, except when contained in eye drops intended for emergency treatment of arc eyes. (S2)

Oxyclozanide, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Oxytetracycline, except when listed elsewhere in the Schedules and except preparations thereof for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947) excluding when intended for administration in animal feed.

Paclitaxel.

Palivizumab.

Palonosetron.

Pamidronate disodium.

Pamidronic acid.

Pancuronium.

Pantoprazole, except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:

(a)

a maximum daily dose of 20 milligrams (S2); and

(b)

a maximum treatment period of 14 days. (S2)Paricalcitol.

Pegfilgrastim.

Pemetrexed.

Penciclovir, except when intended for application to the lips in the early treatment of recurrent Herpes simplex virus infections. (S1)

Penethamate hydriodide, except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Peginterferon alpha.

Penicillamine.

Pentamidine.

Pentostatin.

Pergolide.

Perhexiline.

Phenacetin, except preparations and mixtures intended for external use and containing not more than 0,1 percent phenacetin as stabilizer.

Phenamidine, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Pheneticillin.

Phenindione.

Phenopyrazone.

Phenoxybenzamine.

Phenylbutazone and its derivatives, unless listed in another Schedule.

Phenoxymethylpenicillin, except when intended for the prophylaxis of rheumatic fever. (S3)

Phospholipids, when intended for parenteral administration. (S0)

Phthalylsulfathiazole.

Physostigmine, except ophthalmic preparations thereof when intended for glaucoma. (S3)

Picrotoxin.

Pilocarpine, except ophthalmic preparations thereof intended for glaucoma. (S3)

Pimecrolimus.

Pimobendan.

Pipemidic acid.

Piperacillin, anhydrous.

Pirenzepine.

Piribedil.

Pirlimycin.

Piromidic acid.

Pivampicillin.

Pivmecillinam.

Podophyllum resin, preparations and mixtures containing more than 20 per cent of podophyllum resin. (S1)

Polyethylene glycol — epoetin beta.

Polyglycerylene-dextran.

Polymixin B, except when intended for topical application to the epidermis, nares and external ear. (S1)

Polynoxylin.

Poractant alpha.

Posaconazole.

Potassium dichromate, except preparations and mixtures containing not more than 15 micrograms of potassium dichromate per dosage unit.

Pralidoxime.

Pramipexole.

Pravastatin.

Praziquantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Prednisolone.

Primaguine.

Procainamide.

Procaine benzylpenicillin,except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Procarbazine.

Proguanil, except when used in combination with chloroquine and intended specifically for malaria prophylaxis. (S2)

Propafenone.

Propentofylline, except when intended for veterinary use. (S1)

Propylhexedrine, except when used as a vasoconstrictor and decongestant in nose preparations and inhalants. (S1)

Protein C (isolated from human plasma).

Proyliodone.

Proteolytic (fibrinolytic) enzymes, when intended for injection, and unless listed elsewhere in the Schedules. (S1)

Protionamide.

Proxymetacaine, except when contained in eye drops intended for emergency treatment of arc eyes. (S2)

Pyrazinamide.

Pyricarbate.

Pyridostigmine.

Pyrimethamine.

Quinine, except preparations and mixures containing not more than 1 percent. (S2)

Quinoronium, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Quinupristin.

Rabeprazole.

Ractopamine.

Radiopharmaceuticals, being radioactive compounds and radio-active labelled compounds when used for diagnostic or therapeutic purposes, unless listed elsewhere in the Schedules, and including the following radioisotopes:

(i)Chromium-51;(ii)Gallium-67;(iii)Indium-111;(iv)Iodine-123;(v)Iodine-125;(vi)Iodine-131;(vii)Phosphorous-32;(viii)Strontium-89;(ix)Technetium-99;(x)Thallium-201;(xi)Xenon-133;(xii)Yttrium-90.Rafoxanide, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Raltitrexid.

Ranibizumab.

Rapacuronium.

Rasagiline.

Rasburicase.

Resorantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Raltegravir.Ribavirin.

Rifabutin.

Rifampicin.

Rifaximin.

Riluzole.

Rimiterol, when intended for injection. (S2, S3)

Ritodrine.

Ritonavir.

Rituximab.

Rivaroxaban.

Rizatriptan.

Robenacoxib.

Rocuronium.

Roflumilast.

Rolitetracycline except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of anaplasmosis, footrot, heartwater, navel ill and pneumonia in sheep and cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Ropinirole.

Rosoxacin.

Rosuvastatin.

Roxithromycin.

Roxatidine.

Salbutamol, when intended for injection. (S2, S3)

Salinomycin, except when listed elsewhere in the Schedules and except when intended as an anti-coccidial preparation and to promote growth and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Salmefamol, when intended for injection. (S2, S3)

Salmeterol.

Saquinavir.

Sarafloxacin.

Selegiline.

Selenium salts, preparations thereof for injection, when intended for veterinary use.

Sermorelin.

Sertaconazole, except when intended for application to the skin. (S1)

Sertindole.

Sevelame.

Sildenafil.

Simvastatin.

Sirolimus.

Sisomicin.

Sitagliptin phosphate.

Sodium aurothiomalate.

Sodium cromoglycate, when intended for veterinary use. (S2)

Sodium dihydroazapentacene polysulphonate.

Sodium fluoride; except oral medicinal preparations and mixtures thereof containing 40 milligrams or more per daily dose. (S1)

Sodium nitroprusside.

Solcoseryl, except preparations intended for application to the skin, to the mucous

membranes of the mouth and to the lips and except ophthalmic preparations thereof. (S0, S3)

Sorafenib.

Sparfloxacin.

Spectinomycin.Stavudine.

Stents, Drug Eluting, unless listed elsewhere in the Schedules.

Streptokinase.

Strychnine, except—

(a)

preparations and mixtures containing 0,2 per cent or less of strychnine; (S2) and(b)

subject thereto that it shall only be supplied for the control of problem predatory mammals–(i)on a written prescription issued by a State Veterinarian, for use in the particular State Veterinarian’s area of jurisdiction, and in a quantity not exceeding 5 grams; and(ii)subject to the State Veterinarian obtaining prior written approval for such use from the Director of the concerned provincial conservation institution or authority in his area of jurisdiction, a copy of such written approval being attached to the written prescriptionStyramate.

Sulbactam.

Sulfabenzamide.

Sulfacetamide.

Sulfadiazine, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfadiazine silver, except when intended for application to the skin in the short term treatment of minor burns, provided that the pack size is limited to a maximum of 50 grams; (S2)

Sufadimidine (sulfadimethoxine) except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfamethazine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfadoxine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfafurazole (sulfisoxazole).

Sulfaguanidine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfamethizole.

Sulfamethoxazole except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfametopyrazine.

Sulfamoxole.

Sulfanilamide.

Sulfathiazole, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Sulfisomidine.

Sulfamerazine.

Sulfapyridine.

Sultamicillin.

Sulfonamides, unless listed elsewhere in the Schedules, and except–

(a)

substances, preparations and mixtures intended for application to the eyes, nares and vagina; (S2) and(b)

when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Sumatriptan.

Sunitinib.

Suramin

Surfactant associated proteins.

Suxamethonium.

Suxethonium.

Streptokinase.

Streptomycin.Tacrine.

Tacrolimus.

Tadalafil.

Talampicillin.

Tamoxifen.

Tamsulosin.

Taurolidine.

Tasonermin.

Tazobactam.

Tegafur.

Tegaserod.

Teicoplanin.

Telbivudine.

Telithromycin.

Temozolomide.

Temsirolimus.

Tenecteplase.

Teniposide.

Tenofovir.

Terbinafine, except when intended for application to the skin. (S1)

Terconazole.

Terfenadine.

Terizidone.

Teriparatide.

Tetrabenazine.Tetracycline, except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of anaplasmosis, footrot, heartwater, navel ill and pneumonia in sheep and cattle and derivatives when intended for topical use in the management of wounds in animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Tetramisole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Thalidomide.

Theophylline and its derivatives, unless listed elsewhere in the Schedules, and preparations intended for injection. (S2)

Thiamphenicol.

Thioacetazone.

Thiabendazole, except–

(a)

when intended for application to the skin; (S1) and(b)

when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Tioguanine.

Thiostrepton.

Thymopentin.

Tiamulin, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Tibolone.

Ticarcillin.

Tigecycline.

Tiludronic acid.

Tin fluoride (stannous fluoride), when intended for injection.

Tinidazole.

Tinzaparin.

Tioconazole, except when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

Tiopronin.

Tirilazad.

Tobramycin.

Tocainide.

Tolcapone.

Tolrestat.

Toltrazuril, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Topotecan.

Toremifene.

Tranexamic acid.

Trastuzumab.

Travoprost.

Treosulfan.

Triclabendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Thiotepa.

Trifluridine.

Trimetaphan.

Trimethoprim, except when specifically intended and registered in combination with sulphonamides for the treatment of gastro-enteritis and pneumonia in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Trimetrexate.Trioxysalen.

Triptorelin.

Tromantadine.

Trometamol.

Tropisetron.

Tuberculin.

Tubocurarine.

Tylosin, except when listed elsewhere in the Schedules and except when intended for addition to drinking water and feedstuff for administration to poultry and pigs and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Tyropanoic acid.

Tyrothricin, except when intended for topical application to the epidermis, nares and external ear. (S1)

Unoprostone.

Urapidil.

Urethane.

Urokinase.

Urofollitropin.

{Vaccines, see—Biologicals}

Valaciclovir.

Valganciclovir

Valnemulin.

Vancomycin.

Vardenafil.

Vasoactive intestinal polypeptide.

Vecuronium.Verteporfin.

Vidarabine.

Vildagliptin.

Vinblastine.

Vincristine.

Vindesine.

Vinorelbine.

Virginiamycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Voriconazole.

Vorozole.

Warfarin.

Zalcitabine.

Zanamivir.

Zidovudine.

Zinc bacitracin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Zolmitriptan.

Zoledronic acid.


Schedule 5 and Specified Schedule 5

[Schedule 5 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices Nos. R.143 of 4 February, 1977, R.279 of 25 February, 1977, R.437 of 1 April, 1977, R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of

31 August, 1979, (as amended by Government Notice No. 271 of 15 February, 1980), No. R.2416 of 12 November, 1982, No. R.1289 of 14 June, 1985 and No. 154 of 31 January, 1986, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.2841 of 7 December, 1990, No. R.580 of 21 February, 1992 and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1556 of 16 September, 1994, by Government Notice No. R.673 of 12 May, 1995, by Government Notice No. R.42 of 19 January, 1996, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)

All preparations or mixtures of such substances containing or purporting to contain substances referred to in this Schedule include the following:(i)The salts and esters of such substances, where the existence of such salts and esters is possible; and(ii)all preparations and mixtures of such substances where such preparations and mixtures are not expressly excluded.(b)

In terms of Section 22A (5) ( f ) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe and apply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 5 and Specified Schedule 5 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.(c)

Specified Schedule 5 substances listed in this schedule are subject to additional control in terms of section 22A of the Act as required under the provisions of the 1971 Convention on Psychotropic Substances and are denoted by **Acitretin.

Agomelatine.

Alprazolam**.

Amisulpride.

Amitryptyline and its derivatives.

Amoxapine.

Anaesthetic preparations containing pregnanedione derivatives.

Androstanolone.

Androstenediol.

Aponal.

Apronalide.

Aripriprazole.

Atomoxetine.

Azacyclonol.

Barbituric acid** and its derivatives**, unless listed in another Schedule, excluding- amobarbital, cyclobarbital, pentobarbital and secobarbital (S6), and preparations and mixtures containing not more than 90 milligrams of phenobarbital* per minimum recommended or prescribed dose when intended for continued use in epilepsy. (S3)

Benactyzine and its derivatives unless listed in another Schedule.

Benfluramate.

Benzoctamine.

Benzodiazepines** and their derivatives**, unless listed in another Schedule and except flunitrazepam. (S6)

Benzquinamide.

Beta-aminopropylbenzene and beta-aminoisopropylbenzene:

(a)

any compound structurally derived from either of these substances by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure); and(b)

any salt or substance falling under the above, and(c)

except preparations and mixtures of the above when used as vasoconstrictors and decongestants in antihistamine nose and eye preparations; (S1) and(d)

except when contained in appliances for inhalation in which the substance is absorbed onto

solid material; (S1, S7) and(e)

excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine and preparations and mixtures thereof; and( f )

except substances listed in Schedule 7. (S1, S2, S6)Bolandiol.

Bolasterone.

Boldenone.

Bromides; preparations and mixtures thereof containing 80 milligrams or more of bromine as bromide per recommended daily dose, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 and for anaytical laboratory purposes. (S2)

Bromazepam**.

Bromisovalum.

Brotizolam**.

Bupropion.

Buspirone.

Butriptyline.

Butyrophenones.

Carbromal.

Chloral derivatives, unless listed in another Schedule.

Chlordiazepoxide**.

Chlormethiazole.

Chlormezanone, except mixtures thereof where the maximum recommended or prescribed dose does not exceed 100 milligrams of chlormezanone. (S2)

Chloroform, preparations and mixtures containing more than 20 percent of chloroform.(S1)

Chlorprothixene.

Citalopram.

Clobazam**.

Clomacran.

Clomipramine.

Clonazepam**.

Clopenthixol.

Clorazepic acid**.

Clostebol.

Clothiapine.

Clozapine.

Corticotrophin (adrenocorticotrophic hormone; ACTH).

Cyclobenzaprine.

Cyproheptadine, except when indicated for allergic rhinitis or antipruritic use. (S2)

Danazol.

Deanol and its derivatives, unless listed in another Schedule, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972, and for analytical laboratory purposes. (S1)

Dehydrochloromethyltestosterone.

Desflurane.

Desipramine.

Desvenlafaxine.

Detomidine.

Dexfenfluramine.

Dexmedetomidine.

Dextropropoxyphene; preparations and mixtures for oral use containing not more than 135 milligrams of dextropropoxyphene, calculated as the base, per dosage unit or with a concentration of not more than 2,5 percent in undivided preparations. (S6)

Diazepam**.

Dibenzepin.

Diprenorphine.

Donepezil.

Dosulepin.

Dothiepin.

Doxepin, except when intended for application to the skin. (S4)

Droperidol.

Drostanolone.

Duloxetine.

Ecothiopate.

Emylcamate.

Enflurane.

Epitiostanol.

Escitalopram.

Estazolam**.

Ethchlorvynol**.

Ether (diethyl ether); all substances, preparations and mixtures containing more than 20 percent of ether, (S1), except for industrial purposes including the manufacturing and compounding of products not intended for medicinal use.

Ethinamate** and its derivatives**, unless listed in another Schedule.

Ethylestrenol.Etifoxine.

Etodroxizine, except preparations and mixtures thereof when used solely as an antihistamine. (S2)

Etomidate.

Etretinate.

Fencamfamine**.

Fenfluramine.

Flumazenil**.

Flunitrazepam**.

Fluocinolone.

Fluoxetine.

Fluoxymesterone.

Flupenthixol.

Flurazepam**.

Fluspirilene.

Fluvoxamine.

Formebolone.

Furazabol.

Haloperidol.

Halothane.

Hedonal and its esters, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetics and Disinfectants Act, 1972, and for anaytical laboratory purposes.

Human growth hormone (human somatotropin) – all forms, whether natural or synthetic, including recombinant forms, with either hormonal, prohormonal or anti-hormonal action).

Hydroxyzine.

Hygromycin B, except when listed elsewhere in the Schedules and except when intended as an anthelmintic for pigs and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947)

Imipramine and its derivatives, unless listed elsewhere in the Schedules.

Iproniazid.

Isoflurane.

Ketamine.

Ketazolam**.

Lithium salts, except when intended for application to the skin. (S2)

Lofepramine.

Loprazolam**.

Lorazepam**.

Lormetazepam**.

Loxapine.

Maprotiline.

Mazindol**.

Mebolazine.

Mechlorethamine and its derivatives, unless listed elsewhere in the Schedules.

Meclofenoxate.

Medazepam**.

Medetomidine.

Melitracene.

Mephenoxalone.

Meprobamate**.

Mesterolone.Metandienone.

Metenolone.

Methandranone.

Methandriol.

Methoxyflurane.

Methyltestosterone.

Metrifonate.

Mianserin.

Mibolerone.

Midazolam**.

Milnacipran.

Mitrazapine.

Moclobemide.

Modafinil.

Molindone.

Nalbuphine.

Nandrolone.

Nefazodone.

Nitrazepam**.

Nomifensine.

Norclostebol.

Norethandronlone.

Nortriptyline.

Olanzapine.

Oxabolone.Oxandrolone.

Oxazepam**.

Oxymesterone.

Oxymetholone.

Oxypertine.

Paliperidone.

Paraldehyde.

Pargyline.

Paroxetine.

Pemoline** and its complexes**.

Phenethylhydrazine.

Phenothiazine and its derivatives,

(a)

unless listed in another Schedule,(b)

except preparations and mixtures containing promethazine or dimethothiazine or their salts when used solely as an antihistaminic; (S2) and(c)

except preparations containing promethazine or its salts when intended specifically for the treatment of travel sickness or application to the skin; (S2) and(d)

except phenothiazine when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).Phentermine**.

Pimethixene, except preparations and mixtures thereof when used solely as an antihistaminic. (S2)

Pimozide.

Pipradrol**.

Pizotifen, except preparations and mixtures thereof when used solely as an antihistaminic or when intended for the prophylaxis of migraine. (S2)

Prasterone (Dehydroepiandrosterone, DHEA).

Prazepam**.

Prolintane.

Pregabalin.

Propofol.

Protriptyline.

Quazepam**.

Quetiapine.

Quinbolone.

Quinupramine.

Reboxetine.

Rimonabant.

Risperidone.

Rivastigmine.

Romifidine.

Sertindole

Sertraline.

Sevoflurane.

Sibutramine.

Stanozolol.

Stenbolone.

Sulphonmethane.

Sulpyride.

Temazepam**.

Testolactone.

Testosterone, except subcutaneous implants thereof when specifically intended and registered as a veterinary production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Thioguanosine.

Thiothixene.

Tiapride.

Tiletamine.

Tizanidine.

Tramadol.

Tranylcypromine.

Trazodone.

Trenbolone, except subcutaneous implants thereof when specifically intended and registered as a veterinary production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

Tretinoin, when intended for oral preparation. (S3)

Triazolam**.

Trihexyphenidyl.

Trimipramine.

L-tryptophan, except when intended for medicinal use in dosages of less than 5 mg/kg/day or intended as supplementation for nutritional purposes. (S1)

Varenicline.

Venlafaxine.

Viloxazine.

Xylazine.

Zaleplon.

Zimelidine.

Ziprasidone.

Zolazepam.

Zolpidem**.

Zopiclone.

Zotepine.

Zuclopenthixol.


Schedule 6

[Schedule 6 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.437 of 1 April, 1977, No. R.1674 of 18 August, 1978, No. R.1926 of 31 August, 1979, No. R.658 of 27 March, 1981, No. R.2416 of 12 November, 1982 and No. R.1289 of 14 June, 1985, substituted by Government Notice No. 225 of 17 February, 1989, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1557 of 16 September, 1994 and by Government Notice No. R.1203 of 15 October, 1999, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, amended by Government Notice No. R.491 in Government Gazette 31010 of 25 April, 2008, substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

Wording of Sections

(a)

All preparations or mixtures of such substances containing or purporting to contain substances referred to in this Schedule include the following (unless expressly excluded or unless listed in another Schedule):(i)the isomers of such substances, where the existence of such isomers is possible within the chemical designation;(ii)the esters and ethers of such substances and of the isomers referred to in (i) as well as the isomers of such esters and ethers, where the existence of isomers of such esters or ethers is possible;(iii)the salts of such substances and of the isomers referred to in (i), as well as the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible;(iv)the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible;(v)all preparations and mixtures of any of the above.(b)

In terms of Section 22A(5) ( f ) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe

and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 6 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.Acetorphine.

Acetyldihydrocodeine;

(a)

except oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodeine (calculated as base) per dosage unit; and(b)

except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodeine (calculated as base) per 5 millilitre dosage unit. (S2)Acetylmethadol.

Alfentanil.

Allylprodine.

Alphacetylmethadol.

Alphameprodine.

Alphamethadol.

Alphaprodine.

Amineptine.

Amobarbital.

Anileridine.

Benzethidine.

Benzphetamine.

Benzylmorphine.

Beta-aminopropylbenzene and beta-aminoisopropylbenzene derivatives, being any compound structurally derived from either of these substances by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure):

(a)

except preparations and mixtures of the above when used as vasoconstrictors and decongestants in antihistamine nose and eye preparations; (S1) and(b)

except when contained in appliances for inhalation in which the substance is absorbed in solid material: (S1) and(c)

excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine and preparations and mixtures thereof; (S1, S2, S5) and(d)

except substances listed in Schedule 7. (S1, S2, S5)Betacetylmethadol.

Betameprodine.

Betamethadol.

Betaprodine.

Bezitramide.

Buprenorphine.

Butalbital.

Butorphanol.

Cathine ((+)-norpseudoephedrine / D-norpseudoephedrine).

Chlorodyne (Chloroform and Morphine Tincture BP 1980) or any preparation or mixture thereof described as chlorodyne.

Chlorphentermine.

Clonitazene.

Coca leaf and any salt, compound, derivative or preparation of coca leaf and any salt, compound, derivative or preparation thereof that is chemically equivalent or identical to any of these substances, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except decocainized coca leaf and extractions of coca leaf where such extractions contain no cocaine or ecgonine.

Codeine (methylmorphine);

(a)

except oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of codeine (calculated as base) per dosage unit; and(b)

except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of codeine (calculated as base) per 5 millilitre dosage unit. (S2)Codoxime.

Cyclobarbital.

Desomorphine.

Dextromethorphan.

Dextromoramide.

Dextropropoxyphene, except preparations and mixtures for oral use containing 135 milligrams or less of dextropropoxyphene, calculated as the base, per dosage unit or with a concentration of not more than 2,5 percent in undivided preparations. (S5)

Dextrorphan.

Diampromide.


Diethylthiambutene.

Dihydrocodeine,

(a)

except oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of dihydrocodeine (calculated as base) per dosage unit; (S2) and(b)

except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of dihydrocodeine (calculated as base) per 5 millilitre dosage unit. (S2)Dihydroetorphine.

Dihydromorphine.

Dimenoxadol.

Dimepheptanol.


Dioxaphethyl butyrate.

Diphenoxin (or diphenoxylic acid), except mixtures containing, per dosage unit, 0,5 milligrams or less of difenoxin, calculated as the base, and a quantity of atropine sulphate equal to at least 5 percent of such quantity of difenoxin, calculated as the base, as is present in the mixture. (S2)

Diphenoxylate, except preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit. (S2)

Dipipanone.

{D-norpseudoephedrine - see cathine}

Dronabinol ((-)-transdelta-9-tetrahydrocannabinol), when intended for therapeutic purposes. (S7)

Drotebanol.

Ecgonine, and the esters and derivatives thereof that are convertible to ecgonine and cocaine.

Ephedra alkaloids (natural or synthetic), unless listed separately in the Schedules,

(a)

except products registered in terms of the Act, not intended for export, and being oral preparations and mixtures containing not more than 30 milligrams of ephedra alkaloids per dose, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer; (S2)(b)

except when intended for application to skin, eyes, ears and nares and containing 1 percent or less of ephedra alkaloids. (S1)Ephedrine,

(a)

except products registered in terms of the Act, not intended for export, and being oral preparations and mixtures containing not more than 30 milligrams of ephedrine per dose, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer; (S2)(b)

except preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 percent or less of ephedrine. (S1)


Ethylmorphine,

(a)

except oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per dosage unit; (S2) and(b)

except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per 5 millilitre dosage unit. (S2).Etonitazene.

Etorphine and analogues.

Etoxeridine.

Fenproporex.

Fentanyl, when intended for therapeutic purposes. (S7)

Flunitrazepam.

Furethidine.

Glutethimide.




Hydroxypethidine.

Isomethadone.

Ketobemidone.

Levomoramide.

Levophenacylmorphan.

Levorphanol.

Mecloqualone.

Mefenorex.

Meptazinol.

Metazocine.

Methadone.


Methorphan, including levomethorphan and racemethorphan, but excluding dextromethorphan. (S2)

Methyldesorphine.


Methylphenidate and its derivatives, unless listed in another Schedule.

Metopon.


Morpheridine.

Morphine, except preparations and mixtures of morphine containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S2).


Morphine-N-oxide and its derivatives.

Myrophine (myristylbenzylmorphine).Nicocodine.

Nicodicodine.

Nicomorphine.

Noracymethadol.

Norcodeine,

(a)

except oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of norcodeine (calculated as base) per dosage unit; (S2) and(b)

except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of norcodeine (calculated as base) per 5 millilitre dosage unit. (S2)Norlevorphanol.

Normethadone.


{(+)-Norpseudoephedrine see D-norpseudoephedrine / Cathine}.

Norpipanone.

Opium and opiates and any salt, compound, derivative or preparation of opium or opiates, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except mixtures containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S2)



Oxymorphone (14-hydroxydihydromorphinone or dihydrohydroxymorphinone).

Pentazocine.

Pentobarbital.

Pethidine, pethidine-intermediate A, pethidine-intermediate B and pethidine-intermediate C. (S7)

Phenadoxone.

Phenampromide.

Phenazocine.

Phendimetrazine.

Phenomorphan.

Phenoperidine.

Pholcodine, except preparations and mixtures when compounded with one or more therapeutically active substances, and containing 20 milligrams or less of pholcodine (calculated as base) per dosage unit; and liquid oral preparations and mixtures containing 20 milligrams or less of pholcodine (calculated as base) per 5 millilitre dosage unit. (S2).

Piminodine.

Piritramide.

Proheptazine.

Properidine.

Propiram.

Pseudoephedrine, except contained in products registered in terms of the Act, and not intended for export, being oral preparations and mixtures containing not more than 60 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer.(S2)

Racemoramide.

Racemorphan.

Remifentanil.

Secobarbital.

Sufentanil.

Thebacon.

Thebaine.Thiafentanyl.

Tilidine.

{(-)-transdelta-9-tetrahydrocannabinol - see dronabinol.}

Trimeperidine.

Zipeprol.


Schedule 7

[Schedule 7 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.437 of 1 April,

1977, No. R.1567 of 12 August, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. R.2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.658 of 27 March, 1981, No. R.2416 of 12 November, 1982 and No. R.1289 of 14 June, 1985, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notices No. R.2841 of 7 December, 1990 and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1496 of 13 September, 1996, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, amended by Government Notice No. R.491 in Government Gazette 31010 of 25 April, 2008 and substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008.]

Wording of Sections

All preparations or mixture of such substances containing or purporting to contain substances referred to in this Schedule include the following (unless expressly excluded or unless listed in another Schedule):

(i)the isomers of such substances, where the existence of such isomers is possible within the chemical designation;(ii)the esters and ethers of such substances and of the isomers referred to in (i), as well as the isomers of such esters and ethers, where the existence of isomers of such esters, or ethers is possible;(iii)the salts of such substances and of the isomers referred to in (i), as well as the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible;(iv)the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible;(v)all preparations and mixtures of any of the above.(Trivial or unofficial names are marked *)

Aminorex.

Amphetamine. (S8)

1-Benzylpiperazine (BZP)

Beta-aminopropylbenzene and beta-aminoisopropylbenzene, except any compound structurally derived from either beta-aminopropylbenzene or beta-aminoisopropylbenzene by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure); and presented as:

(a)

preparations and mixtures when used as vasoconstrictors and decongestants in antihistamine

nose and eye preparations; (S1) and(b)

appliances for inhalation in which the substance is absorbed onto solid material; (S1)(c)

excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine; (S1, S2, S5)(d)

except substances listed in S1, S2, S5, and S6.Brolamfetamine ((+)-4-bromo-2,5-dimethoxy-a-methylphenethylamine) *(DOB).

4-bromo-2,5-dimethoxyphenethylamine (2C-B) *(Nexus).


Cannabis (dagga), the whole plant or any portion or product thereof, except:

(a)

when separately specified in the Schedules; (S6) or(b)

processed hemp fibre containing 0.1 percent or less of tetrahydrocannabinol and products manufactured from such fibre, provided that the product does not contain whole cannabis seeds and is in a form not suitable for ingestion, smoking or inhaling purposes; or(c)

processed product made from cannabis seeds containing not more than 10 milligram per kilogram (0,001 percent) of tetrahydrocannabinol and does not contain whole cannabis seeds.[“Processed” means treated by mechanical, chemical or other artificial means but does not include- (a) harvesting; or (b) the natural process of decay”].

Catha edulis (“khat”), the whole plant or any portion or product thereof.

Cathinone((-)-(S)-2-aminopropiophenone).

Dexamphetamine. (S8)

Diethyltryptamine [3-(2-(diethylamino) ethyl) indole] *(DET).

(+)-2,5-dimethoxy-a-methylphenethylamine *(DMA).

2,5-dimethoxy-a-4-dimethylphenethylamine *(DOM, STP) and its derivatives.

2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)

3-(1, 2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-ol*(DMHP).

(+)-N,a-dimethyl-3, 4-(methylenedioxy) phenethylamine *(MDMA).

Dimethyltryptamine [3-(2-(dimethylamino) ethyl) indole] *(DMT).

(+)-4-ethyl-2,5-dimethoxy-a-phenethylamine *(DOET).

Dronabinol [(-)-transdelta-9-tetrahydrocannabinol]. (S6)

Etilamfetamine(N-ethylamphetamine).

Etryptamine.

Fenetylline.

Fentanyl-analogues (unless listed in another Schedule) including:

(i)acetyl-alpha-methylfentanyl;(ii)alpha-methylfentanyl;(iii)alpha-methylfentanyl-acetanilide;(iv)alpha-methylthiofentanyl;(v)benzyl-fentanyl;(vi)beta-hydroxyfentanyl;(vii)beta-hydroxy-3-methylfentanyl;(viii)3-methylfentanyl and its two isomeric forms: cis-N-(3-methyl-1-(2-phenethyl)-4-piperidyl) propionanilide; and

trans-N-(3-methyl-1 -(2-phenethyl)-4-piperidyl) propionanilide;

(ix)3-methylthiofentanyl;(x)para-fluorofentanyl; and(xi)thiofentanyl. (S6)Gamma-hydroxybutyrate *(GHB).



Heroin (diacetylmorphine).

3-hexyl-7, 8, 9, 10-tetrahydro-6,6,0-trimethyl-6H-dibenzo[b,d]-pyran-1-01

*(Parahexyl).

Lefetamine *(SPA).

Lysergide (Lysergic acid diethylamide) *(LSD).


Mesocarb.


Methaqualone and any preparation containing methaqualone.

Methcathinone.

2-methoxy-a-methyl-4,5-(methylenedioxy)phenethylamine*(MMDA).

p-methoxy-a-methylphenethylamine*(PMA).

4 methylaminorex.

{(Methylenedioxyamphetamine *(MDA) and its analogues - see tenamphetamine.}

Methyprylon.

Nabilone. (S8)

Pethidine-analogues, including:

(i)1-methyl-4-phenyl-4-propionoxy-piperidine *(MPPP);(ii)1-methyl-4 phenyl-1,2,5,6-tetrahydropiperidine *(MPTP); and(iii)1-phenylethyl-4-phenyl-4-acetyloxy-piperidine*(PEPAP).except pethidine-intermediate A. pethidine-intermediate B and pethidine-intermediate C. (S6)

Phencyclidine *(PCP) and its congeners, including:

(i)eticyclidine (N-ethyl-1 -phenylcyclohexylamine) *(PCE);(ii)rolycyclidine (1-(1-phenylcyclohexyl) pyrrolidine) *(PHP or PCPY); and(iii)tenocyclidine (1-[1-(2-thienyl) cyclohexyl] piperidine) *(TCP).Phenmetrazine.

Psilocin (4-hydroxy-NN-dimethyltryptamine).

Psilocybine(4-phosphoryloxy-NN-dimethyltryptamine).

Pyrovalerone (4’-methyl-2-(1-pyrrolidinyl) valerophenone).

Tenamfetamine (methylenedioxyamphetamine) *(MDA) and its analogues:

(i)(+)-N-ethyl-a-methyl-3,4-(methylenedioxy) phenethylamine *(N-ethyl MDA);(ii)(+)-N-[a-methyl-3,4-(methylenedioxy) phenethyl] hydroxylamine *(N-hydroxy MDA).Tetrahydrocannabinol and their alkyl homologues, except:

(a)

when separately specified in the Schedules;(b)

dronabinol ((-)-transdelta-9-tetrahydrocannabinol), when intended for therapeutic purposes; (S6)(c)

in hemp seed oil, containing 10 milligram per kilogram or less of tetrahydrocannabinols, when labelled "Not to be taken" or "Not for internal human use"; or(d)

in products for purposes other than internal human use containing 10 milligram per kilogram or less of tetrahydrocannabinols.[“Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.]

1-(3-trifluoromethylphenyl) piperazine *(TFMPP).

(+)-3, 4, 5-trimethoxy-a-methylphenethylamine *(TMA).


Schedule 8

[Schedule 8 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.437 of 1 April, 1977, No. R.1567 of 12 August, 1977, No. R.1674 of 18 August, 1978 (as amended by Government Notice No. 2410 of 8 December, 1978), No. R.1926 of 31 August, 1979, No. R.658 of 27 March, 1981, No. R.2416 of 12 November, 1982 and No. R.1289 of 14 June, 1985, substituted by Government Notice No. 225 of 17 February, 1989, amended by

Government Notices No. R.1133 of 2 June, 1989, No. R.2841 of 7 December, 1990 and No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991, amended by Government Notice No. R.1556 of 16 September, 1994, by Government Notice No. R.1203 of 15 October, 1999 and by Government Notice No. R.1077 of 3 November, 2000, repealed by s. 27 of Act No. 90 of 1997, inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003 and substituted by Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008.]

Wording of Sections

All preparations or mixture of such substances containing or purporting to contain substances referred to in this Schedule include the following (unless expressly excluded or unless listed in another Schedule):

(i)the isomers of such substances, where the existence of such isomers is possible within the chemical designation;(ii)the esters and ethers of such substances and of the isomers referred to in (i), as well as the isomers of such esters and ethers, where the existence of such isomers of esters and ethers is possible;(iii)the salts of such substances and of the isomers referred to in (i), as well as the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible;(iv)the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible;(v)all preparations and mixtures of any of the above.Amphetamine and its salts; preparations thereof. (S7)

Dexamphetamine and it salts; preparations thereof. (S7)

Nabilone. (S7)


Schedule 9

[Schedule 9 added by s. 36 of Act No. 65 of 1974, substituted by Government Notices No. R.420 of 7 March, 1975, No. R.2244 of 28 November, 1975, No. R.575 of 2 April, 1976 and No. R.2082 of 5 November, 1976, amended by Government Notices No. R.437 of 1 April, 1977, No. R.2416 of 12 November, 1982 and No. R.1289 of 14 June, 1985, substituted by Government Notice No. 225 of 17 February, 1989, amended by Government Notice No. R.775 of 7 May, 1993, repealed, and subsequently re-inserted (after amendment), by s. 21 of Act No. 94 of 1991 and repealed by s. 27 of Act No. 90 of 1997.]

Wording of Sections


DRUGS CONTROL AMENDMENT ACTNO. 29 OF 1968

[ASSENTED TO 26 MARCH, 1968][DATE OF COMMENCEMENT: 3 APRIL, 1968]


(English text signed by the Acting State President)

This Act was published in Government Gazette 2032 dated 3 April, 1968.

ACTTo amend the Drugs Control Act, 1965, so as to enable the Drugs Control Council to determine from time to time which drugs shall be subject to registration; so as to provide for the classification of drugs into classes or categories, for the cancellation of the registration of any drug in respect of which prescribed annual fees have not been paid and for prescribing such fees; and to provide for matters incidental thereto.

1. (1) Substitutes section 14 of the Drugs Control Act, No. 101 of 1965.

(2) Any regulation promulgated under section 35 (1) (c) of the principal Act and in force immediately prior to the date of commencement of this Act shall for the purposes of the principal Act as amended by this Act be deemed to be a resolution of the Drugs Control Council taken and published in the Gazette under section 14 (2) of the principal Act as substituted by subsection (I) of this section on the date of commencement of such regulation .

2. Amends section 15 of the Drugs Control Act, No. 101 of 1965, by substituting in subsections (10) and (11) the expression “subsection (3)” for the expression “subsection (2)”.

3. Amends section 16 of the Drugs Control Act, No. 101 of 1965, by substituting subsection (4).

4. Amends section 17 (2) of the Drugs Control Act, No. 101 of 1965, by substituting the expression "subsection (3)” for the expression “subsection (2)” where it occurs for the first time.

5. Amends section 35 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (c) (date of commencement 1 April, 1966); paragraph (b)

substitutes subsection (4) (c); and paragraph (c) inserts subsection 6A (date of commencement 1 April, 1966).

6. Short title.—This Act shall be called the Drugs Control Amendment Act, 1968.


[ASSENTED TO 1 OCTOBER, 1970][DATE OF COMMENCEMENT: 21 OCTOBER, 1970]


This Act was published in Government Gazette 2897 dated 21 October, 1970.

ACT

To amend the Drugs Control Act, 1965, in relation to the making of regulations in connection with the advertising of drugs.

1. Amends section 35 (1) of the Drugs Control Act, No. 101 of 1965, by substituting paragraph (i).

2. Short title.—This Act shall be called the Drugs Control Amendment Act, 1970.

DRUGS LAWS AMENDMENT ACTNO. 95 OF 1971

[ASSENTED TO 18 JUNE, 1971][DATE OF COMMENCEMENT: 6 DECEMBER, 1971


This Act has been updated to Government Gazette 4445 dated 16 October, 1974.

as amended by

Medical, Dental and Supplementary Health Service Professions Act, No. 56 of 1974

ACT

To amend the provisions of the Medical, Dental and Pharmacy Act, 1928, relating to the definition of habit-forming drugs and potentially harmful drugs; to empower the Minister to authorize certain categories of persons to perform certain acts in relation to potentially harmful drugs; to amend the provisions of the Drugs Control Act, 1965, relating to the making of regulations in connection with the advertising of drugs; and to provide for incidental matters.

1 to 6 inclusive . . . . . .

[Ss. 1 to 6 inclusive repealed by s. 64 of Act No. 56 of 1974.]

Wording of Sections

Wording of Sections s 1, s 6 of Act 95 of 1971 prior to amendment by Act 56 of 1974

7. Amends section 35 (1) of the Drugs Control Act, No. 101 of 1965, by substituting paragraph (i).

8. Short title and commencement.—This Act shall be called the Drugs Laws Amendment Act, 1971, and shall come into operation on a date to be fixed by the State President by proclamation in the Gazette.


[ASSENTED TO 23 OCTOBER, 1974][DATE OF COMMENCEMENT: 21 FEBRUARY, 1975]


The Government Gazette information for this Act is currently being researched and will be updated as soon as it becomes available.

ACT

To amend the Drugs Control Act, 1965, so as to replace or define or further define certain expressions; to substitute the appellation “medicine” for the appellation “drug” in the English text, and to effect certain textual changes in that text arising out of such substitution; to further regulate the control of medicines; to further regulate the constitution of the Medicines Control Council and the remuneration of its members, of the members of its committees and

of the members of the Medicines Control Appeal Board; to provide for the control of Scheduled substances; to make new provision for inspectors, analysts, pharmacologists and pathologists considered necessary for the proper enforcement of the said Act; and to effect a change in relation to the power to make regulations; and to provide for matters connected therewith.


(2) Any reference, in any law or elsewhere, to a drug as defined in section 1 of the principal Act prior to the substitution thereof by subsection (1) of this section, shall be deemed to be a reference to a medicine as defined in the said section 1 as so substituted.


(2) The Drugs Control Council established by section 2 of the principal Act prior to the substitution thereof by subsection (1) of this section, shall for all purposes be deemed to be and at all times to have been the Medicines Control Council referred to in the said section 2 as substituted by the said subsection (1), and any reference in any law or elsewhere to the Drugs Control Council shall be construed accordingly.

3. Amends section 3 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); paragraph (b) substitutes subsection (2) (a); paragraph (c) substitutes in subsection (2) (c) the word “medicines” for the word “drugs”; and paragraph (d) substitutes subsection (2) (d).

4. (1) Amends section 4 of the Drugs Control Act, No. 101 of 1965, by substituting subsection (4).

(2) Notwithstanding the provisions of section 4 (1) of the principal Act, any person who is at the commencement of this Act a member of the council referred to in that section, shall vacate his office as such on a date fixed by the State President by proclamation in the Gazette.

5. Amends section 6 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (b); paragraph (b) substitutes subsection (1) (c); paragraph (c) substitutes subsection (2) (c); and paragraph (d) substitutes subsection (4).




(2) The Drugs Control Appeal Board established by section 10 of the principal Act prior to the substitution thereof by subsection (1) of this section, shall for all purposes be deemed to be and at all times to have been the Medicines Control Appeal Board referred to in the said section 10 as substituted by the said subsection (1), and any reference in any law or elsewhere to the said Drugs Control Appeal Board shall be construed accordingly.

9. Amends section 11 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) ( f ); paragraph (b) substitutes subsection (1) (g); paragraph (c) substitutes subsection (2) (c); and paragraph (d) substitutes in subsection (4) the word “medicine” for the word “drug” wherever it occurs.


(2) (a) Any reference in any other law to the Registrar of Drugs referred to in section 12 of the principal Act prior to the substitution thereof by subsection (1) of this section, shall be construed as a reference to the Registrar of Medicines referred to in the said section 12 as substituted by the said subsection (1).

(b) Anything done by the said Registrar of Drugs prior to the commencement of this section in the administration of any law, shall be deemed to have been done by the said Registrar of Medicines.

(c) The person who held office as the said Registrar of Drugs immediately prior to the commencement of this section, shall be deemed to have been appointed as the said Registrar of Medicines under section 12 of the principal Act as substituted by subsection (1) of this section.

11. (1) Amends section 13 of the Drugs Control Act, No. 101 of 1965, by substituting the word “medicine” for the word “drug” wherever it occurs.(2) The drugs register referred to in section 13 of the principal Act prior to the commencement of subsection (1) of this section shall be deemed to be the medicines register referred to in section 13 of the principal Act as amended by subsection (1) of this section, and any drug registered in the said drugs register prior to such commencement shall be deemed to be a medicine registered in the said medicines register.


(2) Any drug which prior to the commencement of subsection (1) was subject to registration by virtue of a resolution published in terms of subsection (2) of section 14 of the principal Act, shall be deemed to be a medicine subject to registration by virtue of a resolution published in terms of subsection (2) of section 14 of the principal Act as substituted by subsection (1) of this section.

13. Substitutes section 15 of the Drugs Act, No. 101 of 1965.

14. Amends section 16 of the Drugs Control Act, No. 101 of 1965, by substituting the word “medicine” for the word “drug” wherever it occurs.

15 and 16. Substitute respectively sections 17 and 18 of the Drugs Control Act, No. 101 of 1965.


18. Amends section 20 of the Drugs Control Act, No. 101 of 1965, by substituting the word

“medicine” for the word “drug” wherever it occurs.


20. Substitutes section 22 of the Drugs Control Act, No. 101 of 1965.

21. Inserts section 22A in the Drugs Control Act, No. 101 of 1965.




(2) Any person appointed, prior to the commencement of subsection (1) of this section, as an inspector under section 26 (1) of the principal Act, whose appointment as such was in force immediately prior to such commencement, shall be deemed to have been authorized as an inspector under section 26 (1) of the principal Act as substituted by subsection (1) of this section.


(2) Any analyst, pharmacologist or pathologist appointed, prior to the commencement of subsection (1) of this section, under section 27 (1) of the principal Act, whose relevant appointment was in force immediately prior to such commencement, shall be deemed to have been granted authority under section 27 of the principal Act as substituted by subsection (1) of this section.

26. Amends section 28 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes in subsections (1) and (2) the words “medicine or Scheduled substance” for the word “drug” wherever it occurs; and paragraph (b) substitutes subsection (4).

27. Amends section 29 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes paragraph (h); paragraph (b) substitutes paragraph (i); paragraph (c) adds the word “or” at the end of paragraph ( j); and paragraph (d) adds paragraph (k).

28. Amends section 30 of the Drugs Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes in subsection (2) the words “medicine or Scheduled substance” for the word “drug”; and paragraph (b) substitutes subsection (3).

29. Amends section 31 (1) (a) and (d) of the Drugs Control Act, No. 101 of 1965, by substituting the words “medicine or Scheduled substance” for the word “drug”.



(2) Any regulation which was in force under section 35 of the principal Act immediately prior to the commencement of subsection (1), shall remain in force until it is amended or withdrawn under the said section 35.

32. Amends section 36 of the Drugs Control Act, No. 101 of 1965, by substituting the word “medicine” for the word “drug”.


34. Inserts section 37A in the Drugs Control Act, No. 101 of 1965.


36. Adds Schedules 1, 2, 3, 4, 5, 6, 7, 8 and 9 to the Drugs Control Act, No. 101 of 1965.

37. Substitutes the long title of the Drugs Control Act, No. 101 of 1965.

38. (1) Repeals sections 48 to 72 of and the Fourth and Sixth Schedules to the Medical, Dental and Pharmacy Act, No. 13 of 1928.

(2) Anything done in terms of a provision repealed by subsection (1) shall, if it could be done in terms of a provision of the principal Act as amended by this Act, be deemed to have been done in terms of such last-mentioned provision.




39. Short title and commencement.—This Act shall be called the Drugs Control Amendment Act, 1974, and shall come into operation on a date fixed by the State President by proclamation in the Gazette.

MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACTNO. 19 OF 1976

[ASSENTED TO 15 MARCH, 1976][DATE OF COMMENCEMENT: 31 MARCH, 1976]


This Act was published in Government Gazette 5035 dated 31 March, 1976.

ACT

To amend the Medicines and Related Substances Control Act, 1965, so as to further regulate the authorizing of persons as inspectors; to provide for the delegation of powers; and to further define the power to make regulations.

1. Amends section 26 of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting subsection (2).

2. Inserts section 34A in the Medicines and Related Substances Control Act, No. 101 of 1965.

3. Amends section 35 (1) of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes paragraph (xxiii); and paragraph (b) inserts paragraph (xxviA).

4. Short title.—This Act shall be called the Medicines and Related Substances Control Amendment Act, 1976.

HEALTH LAWS AMENDMENT ACTNO. 36 OF 1977

[ASSENTED TO 22 MARCH, 1977][DATE OF COMMENCEMENT: 30 MARCH, 1977]


This Act has been updated to Government Gazette 8160 dated 21 April, 1982.

as amended by

Associated Health Service Professions Act, No. 63 of 1982

ACT

To amend the Medicines and Related Substances Control Act, 1965, so as to provide for an increase of the membership of the Medicines Control Council; to amend the Mental Health Act, 1973, so as to regulate the expiry of the period of office of certain members of a hospital board; and to make provision for the payment of amounts for the treatment of certain persons in certain state institutions; to amend the Homeopaths, Naturopaths, Osteopaths and

Herbalists Act, 1974,so as to apply that Act to the territory of South West Africa; and to prohibit persons pursuing certain practices from committing certain acts with patients; to amend the Pharmacy Act, 1974,so as to further regulate the carrying on of the business of retail pharmacist by bodies corporate; and to regulate the training and control of pharmaceutical auxiliary personnel; to amend the Medical, Dental and Supplementary Health Service Professions Act, 1974,so as to provide for the registration of student interns; for the limited registration of certain persons in respect of supplementary health service professions, and the exemption of persons so registered from the restrictions imposed in respect of their registration, upon compliance by them with certain requirements; for the performance of certain acts by student interns; for the granting of authority to certain registered persons to supply certain medicines in certain circumstances; and for the making of regulations relating to the removal by the council from the registers in question of the names of medical, dental or psychology students, the nature and duration of training to be undergone by persons who have obtained certain certificates before they may be registered in respect of supplementary health service professions, the registration of student interns and the conduct of inquiries into the conduct or alleged conduct of members of supplementary health service professions; and to provide for incidental matters.

1. Amends section 3 of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting subsection (1).2. Amends section 47 of the Mental Health Act, No. 18 of 1973, by substituting subsection (2.

3. Amends section 77 (1) of the Mental Health Act, No. 18 of 1973, by substituting paragraph (o.

4 to 8 inclusive. . . . . . .

[Ss.4 to 8 inclusive repealed by s. 42 (1) of Act No.63 of l982.]

9. Amends section 22 of the Pharmacy Act, No. 53 of 1974, as follows:—paragraph (a) deletes the word “or” at the end of subsection (1) (b) (iii); paragraph (b) adds the word “or” at the end of subsection (1) (b) (iv); paragraph (c) adds subsection (I) (b) (v); paragraph (d) substitutes subsection (1) (e); and paragraph (e) adds subsection (6).

10. Inserts section 22A in the Pharmacy Act, No. 53 of 1974.

11. Amends section 49 (1) of the Pharmacy Act, No. 53 of 1974, by substituting paragraph (m).

12. Amends section 1 of the Medical, Dental and Supplementary Health Service Professions Act, No. 56 of 1974, by inserting the definition of “student intern”.

13. Amends section 18 of the Medical, Dental and Supplementary Health Service Professions Act, No 56 of 1974 by substituting subsection (1).

14. Amends section 32 of the Medical, Dental and Supplementary Health Service Professions Act, No. 56 of 1974, by substituting subsection (1).

15. Inserts sections 32A and 32B in the Medical, Dental and Supplementary Health Service

Professions Act. No 56 of 1974.

16. Amends section 36 (2) of the Medical, Dental and Supplementary Health Service Professions Act, No. 56 of 1974, by inserting paragraph (aA).

17. Inserts section 52A in the Medical, Dental and Supplementary Health Service Professions Act. No 56 of 1974.

18. Amends section 61 (1) of the Medical, Dental and Supplementary Health Service Professions Act, No 56 of 1974, as follows:—paragraph (a) substitutes paragraph (h) (i); paragraph (b) adds paragraph (I) (viii); paragraph (c) substitutes paragraph (n); and paragraph (d) substitutes in paragraph (r) the words preceding subparagraph (i).

19. Short title.—This Act shall be called the Health Laws Amendment Act, 1977.

MEDICINES AND RELATED SUBSTANCES CONTROL AMENDMENT ACTNO. 17 OF 1979[ASSENTED TO 13 MARCH, 1979][DATE OF COMMENCEMENT: 21 MARCH, 1979]



ACT

To amend the Medicines and Related Substances Control Act, 1965, so as to define or further define certain expressions; to further regulate the constitution of the Medicines Control Council and the Medicines Control Appeal Board; to extend the provisions of the said Act to medicines intended for animals; to make new provisions in relation to the labelling and advertising of medicines; to further regulate the furnishing of information regarding the registration of medicines and the cancellation of such registration; to make further provision for the control of Scheduled substances and for the authorization of inspectors, analysts, pharmacologists and pathologists to act in terms of the said Act; to further regulate the taking of and dealing with samples of medicines and Scheduled substances; and to effect a change in relation to the power to make regulations; and to provide for matters connected therewith.

ARRANGEMENT OF SECTIONS

1. 2.

3. 4. 5. 6. 7 and 8. 9. 10. 11. 12. 13. 14. 15. 16. Short title

1. Amends section 1 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) inserts the definition of “export”; paragraph (b) inserts the definition of “immediate container”; paragraph (c) substitutes the definition of “medical practitioner”; paragraph (d) substitutes the definition of “medicine”; paragraph (e) substitutes the definition of “pharmacist”; paragraph ( f ) inserts the definition of “pharmacist’s assistant”; paragraph (g) deletes the definition of “unqualified assistant”; paragraph (h) adds the definition of “veterinary medicine”; paragraph (i) substitutes subsection (2); and paragraph ( j) substitutes subsection (3).

2. Amends section 3 of the Medicines and Related Substances Control Act, No. 101 of 1965, as fo11ows.—paragraph (a) substitutes subsection (1); and paragraph (b) inserts subsection (2) (dA).

3. Amends section 6 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (b); and paragraph (b) substitutes subsection (4).

4. Amends section 10 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes in subsection (1) the words preceding paragraph (a); paragraph (b) substitutes subsection (1) (b); paragraph (c) inserts subsection (1) (bA); and paragraph (d) adds subsection (3).



7 and 8. Substitute respectively sections 18 and 22 of the Medicines and Related Substances Control Act, No. 101 of 1965.

9. Amends section 22A of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes the proviso to subsection (3); paragraph (b) substitutes subsection (4); paragraph (c) substitutes subsection (5) (a); paragraph (d) substitutes subsection (5) (c); paragraph (e) substitutes in subsection (6) (a) the words preceding the proviso; paragraph ( f ) substitutes subsection (6) (c); paragraph (g) substitutes the first proviso to subsection (6) (d); paragraph (h) substitutes subsection (7) (b) (i) paragraph (i) substitutes subsection (7) (e); paragraph ( j) substitutes subsection (8) ( f ); paragraph (k) substitutes subsection (8) (g); paragraph (l) inserts subsection (9) (bA); paragraph (m) substitutes subsection (9) ( f ); paragraph (n) substitutes subsection (9) (g); paragraph (o) deletes subsection (13); and paragraph (p) adds subsection (15) (c) and (d).


11. Substitutes section 27 of the Medicines and Related Substances Control Act, No. 101 of 1965.

12. Amends section 28 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (2); and paragraph (b) substitutes subsection (3).


14. Amends section 35 (1) of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) inserts paragraph (xxvA); paragraph (b) substitutes paragraph (xxviA); paragraph (c) substitutes paragraph (xxvii); and paragraph (d) substitutes

paragraph (xxx).

15. Substitutes the long title of the Medicines and Related Substances Control Act, No. 101 of 1965.



[ASSENTED TO 16 FEBRUARY, 1981][DATE OF COMMENCEMENT: 4 MARCH, 1981]



ACT

To amend the Medicines and Related Substances Control Act, 1965, with respect to certain definitions; so as to provide for the amendment of entries in the medicines register; to provide for the transfer of certain certificates of registration; and to alter certain designations; and to provide for incidental matters.

1. Amends section 1 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes paragraph (a) of the definition of “advertisement”; paragraph (b) inserts the definition “certificate of registration”; paragraph (c) inserts the definition of '“Director-General”'; paragraph (d) substitutes the definition of “Minister”; paragraph (e) inserts the definition of “public”; paragraph ( f ) deletes the definition of “Secretary”; and paragraph (g) substitutes subsection (2).


3. Inserts sections 15A and 15B in the Medicines and Related Substances Control Act, No. 101 of 1965.

4. Amends section 16 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) substitutes subsection (4).

5. Amends section 17 of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting paragraph (b).

6. Amends section 22 (1) of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting paragraph (b).

7. Amends section 35 (1) of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting paragraph (i).

8. Change of certain designations.—The principal Act is hereby amended by the substitution for the expressions “Department of Health” and “Secretary”, wherever they occur, of the expressions “Department of Health, Welfare and Pensions” and “Director-General” respectively.



[ASSENTED TO 27 JUNE, 1991][DATE OF COMMENCEMENT: 12 JULY, 1991]



This Act has been updated to Government Gazette 18505 dated 12 December, 1997.

as amended by

Health and Welfare Matters Amendment Act, No. 118 of 1993

[with effect from 20 July, 1993]

Health and Welfare Matters Second Amendment Act, No. 180 of 1993


ACT

To amend the Medicines and Related Substances Control Act, 1965, so as to delete certain definitions and to define or further define certain expressions; to further regulate the powers, functions and constitution of the Medicines Control Council; to do away with the disqualification that a member of the council may not have an interest in the sale of any medicine; to abolish the Medicines Control Appeal Board; to remove legal uncertainty

regarding the sale of unregistered medicine by medical practitioners, veterinarians, pharmacists, practitioners and dentists; to regulate the control of the sale of medicines and Scheduled substances differently; to authorize the council to disclose certain information regarding medicines, Scheduled substances and medical devices; to make new provision for appeals against decisions of the council; to increase penalties; to further regulate the preservation of secrecy; to provide for the delegation of the powers of the Minister of National Health in terms of the said Act; to extend the power to make regulations; to provide for a prohibition on the manufacture, sale or use of certain veterinary medicines; to provide for the registration and control of medical devices; to delete certain outdated references; to repeal the Schedules to the said Act; and to make certain adjustments to certain other laws in consequence of the amendments to the said Act; and to provide for incidental matters.

1. Amends section 1 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) deletes the definition of “appeal board”; paragraph (b) substitutes the definition of “Director-General”; paragraph (c) inserts the definition of “medical device”; paragraph (d) substitutes the definition of “medical practitioner”; paragraph (e) deletes the definition of “medicinal purpose” (date of commencement to be proclaimed); paragraph ( f ) substitutes the definition of “Minister”; paragraph (g) inserts the definition of “nurse”; paragraph (h) substitutes the definition of “pharmacist”; paragraph (i) deletes the definition of “pharmacist’s assistant” (date of commencement to be proclaimed); paragraph ( j) substitutes the definition of “pharmacologist”; paragraph (k) deletes the definition of “pharmacy Board” (date of commencement to be proclaimed); paragraph (l) inserts the definition of “practitioner”; paragraph (m) substitutes the definition of “Scheduled substance”; paragraph (n) deletes the definitions of “Schedule 1 substance”, “Schedule 2 substance”, “Schedule 3 substance”, “Schedule 4 substance”, “Schedule 5 substance”, “Schedule 6 substance”, “Schedule 7 substance”, “Schedule 8 substance” and “Schedule 9 substance”; paragraph (o) deletes the definitions of “the territory” (date of commencement to be proclaimed) and “trainee pharmacist”; and paragraph (p) substitutes the definition of “veterinarian”.

2. Amends section 2 of the Medicines and Related Substances Control Act, No. 101 of 1965, by adding subsection (2), the existing section becoming subsection (1).

3. Amends section 3 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) substitutes subsection (2) (d), (dA), (e) and ( f ).

4. Amends section 6 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (b); paragraph (b) deletes subsection (1) (c); and paragraph (c) deletes subsection (4).

5 and 6. Repeal respectively sections 10 and 11 of the Medicines and Related Substances Control Act, No. 101 of 1965.

7. Amends section 14 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (2) (b); paragraph (b) substitutes the words preceding subsection (3) (a); and paragraph (c) substitutes subsection (4).

8. Amends section 15 (10) of the Medicines and Related Substances Control Act, No. 101 of 1965, by substituting paragraph (a).

9. . . . . . .

[S. 9 inserted by s. 1 of Act No. 180 of 1993 and repealed by s. 30 of Act No. 90 of 1997.]

Wording of Sections


10. Inserts section 22B in the Medicines and Related Substances Control Act, No. 101 of 1965.


12. Amends section 29 of the Medicines and Related Substances Control Act, No. 101 of 1965, by adding paragraphs (l) and (m).


14 and 15. Substitute respectively sections 34 and 34A of the Medicines and Related Substances Control Act, No. 101 of 1965.

16. Amends section 35 of the Medicines and Related Substances Control Act, No. 101 of 1965, as follows:—paragraph (a) inserts subsection (1) (viA); paragraph (b) substitutes subsection (1) (xii);

[Paras (c) to (h) inclusive deleted by s. 30 of Act No. 90 of 1997.]

paragraph (i) inserts subsection (1) (xxxA) and (xxxB); and paragraph ( j) substitutes subsection (7).

17. Inserts section 36A in the Medicines and Related Substances Control Act, No. 101 of 1965.


19. . . . . . .


Wording of Sections


20. Repeals section 39 of the Medicines and Related Substances Control Act, No. 101 of

1965.

21. . . . . . .


Wording of Sections


22. Substitutes the long title of the Medicines and Related Substances Control Act, No. 101 of 1965.23. . . . . . .


Wording of Sections

24. . . . . . .


Wording of Sections



25. . . . . . .


Wording of Sections


26. Amends section 1 of the Nursing Act, No. 50 of 1978, by substituting the definition of “medicinal purposes”.



27. Amends section 38 of the Associated Health Service Professions Act, No. 63 of 1982,

by substituting subsection (3).

28. Transitional provision.—Any reference in any law or document to any medicine or other substance included in any Schedule to the principal Act prior to the date of commencement of section 21 of this Act, and which is still in force on the said date of commencement, shall be construed from that date as a reference to an appropriate medicine or other substance prescribed by the Minister under section 22A of the principal Act, as amended by section 9 of this Act.

29. Short title and commencement.—(1) (a) This Act shall be called the Medicines and Related Substances Control Amendment Act, 1991, and shall, with the exclusion of the provisions referred to in paragraph (b), be deemed to have come into operation on 12 July 1991.

(b) Sections 9, 16 (c) up to and including (h), 19, 21, 23, 24 and 25 shall come into operation on a date fixed by the State President by proclamation in the Gazette.


Wording of Sections

(2) . . . . . .

[Sub-s. (2) deleted by s. 2 (b) of Act No. 180 of 1993.]

Wording of Sections

(3) Proclamation R.66 of 12 July 1991 is hereby repealed.


Wording of Sections




GENERAL LAW AMENDMENT ACTNO. 49 OF 1996

[ASSENTED TO 27 SEPTEMBER, 1996][DATE OF COMMENCEMENT: 4 OCTOBER, 1996]

(Afrikaans text signed by the President)

This Act has been updated to Government Gazette 19959 dated 21 April, 1999.

as amended by

Wine and Spirit Control Act, No. 47 of 1970

[with effect from 30 June, 1999]Road Accident Fund Act, No. 56 of 1996

[with effect from 1 May, 1997]

Marine Living Resources Act, No. 18 of 1998

[with effect from 1 September, 1998]

University of Cape Town (Private) Act, No. 8 of 1999

[with effect from 29 September, 1999]

ACT

To amend or repeal South African legislation, so as to substitute or delete all references to “South-West Africa”; and to provide for matters connected therewith.

Repealed Act Act 47 of 1970 has been repealed by s 58D of Act 47 of 1970

1. Amends or repeals the laws to the extent set out in the Schedule.

2. Short title.—This Act shall be called the General Law Amendment Act, 1996.

SCHEDULE

LAND SURVEY ACT, NO. 9 OF 1927

Amends section 49 of the Land Survey Act, No. 9 of 1927, by deleting the expressions “or in the Deeds Registry Proclamation, 1939 (Proclamation No. 37 of 1939), of the territory of South-West Africa”, and “and the Mining Titles Office at Windhoek” from the definition of “deeds registry”.

CURRENCY AND EXCHANGES ACT, NO. 9 OF 1933

Amends section 9 of the Currency and Exchanges Act, No. 9 of 1933, by deleting subsection (6).

INSOLVENCY ACT, NO. 24 OF 1936

Amends section 2 of the Insolvency Act, No. 24 of 1936, as follows:—paragraph (a) deletes the definition of “Gazette”, paragraph (b) deletes the definition of “Republic”, paragraph (c) deletes the definition of “Supreme Court”, and paragraph (d) deletes the definition of “the Territory”.

Amends section 4 (1) of the Insolvency Act, No. 24 of 1936, by deleting the two provisos.

Amends section 21 (2) (d) of the Insolvency Act, No. 24 of 1936, by deleting the expression “or by the Insurance Ordinance, 1927 (Ordinance No. 12 of 1927 of the Territory)”.

Amends section 49 (2) of the Insolvency Act, No. 24 of 1936, by deleting the expression “or the Commissioner for Inland Revenue of the Territory”.

Amends section 89 (5) of the Insolvency Act, No. 24 of 1936, by deleting the expression “or the Administration of the Territory”.

Amends section 90 of the Insolvency Act, No. 24 of 1936, by deleting the expression “or the Land Agricultural Bank of south-west Africa”.

Amends section 101 (a) of the Insolvency Act, No. 24 of 1936, by deleting the expression “the Territory or”.

Amends section 124 (2) (c) of the Insolvency Act, No. 24 of 1936, by deleting the expression “or of the Insolvency Ordinance, 1928 (Ordinance No. 7 of 1928), of the Territory”.

Amends section 134 (1) of the Insolvency Act, No. 24 of 1936, by deleting the expression “or, in the case of an insolvent whose estate has been sequestrated by an order of the High Court of South-West Africa, the German language,”.

Repeals section 158ter of the Insolvency Act, No. 24 of 1936.

POLICE AND PRISON OFFICERS PAY ACT, NO. 30 OF 1939

Amends the long title of the Police and Prisons Officers Pay Act, No. 30 of 1939, by deleting the expression “and members of the South-West Africa Police”.

Amends section 1 of the Police and Prisons Officers Pay Act, No. 30 of 1939, by deleting paragraph (c) and by deleting the expression “, and the European members of the South-West African Police”.

Repeals section 2 of the Police and Prisons Officers Pay Act, No. 30 of 1939.

INDUSTRIAL DEVELOPMENT ACT, NO. 22 OF 1940

Amends section 1 of the Industrial Development Act, No. 22 of 1940, by deleting the definition of “Republic”.

MERCHANDISE MARKS ACT, NO. 17 OF 1941

Amends section 1 of the Merchandise Marks Act, No. 17 of 1941, as follows:—paragraph (a) deletes the definitions of “Gazette”, “Territory” and “Union”; and paragraph (b) deletes the expression “, or the Patents, Designs, Trade Marks and Copyright Proclamation, 1923 (Proclamation No. 17 of 1923 of the Territory) or an amendment thereof” in the definition of “trade mark”.

Amends section 14 of the Merchandise Marks Act, No. 17 of 1941, as follows:—paragraph (a) deletes the expression “, or in the case of the Territory, the first day of March, 1952” in the proviso to subsection (1); and paragraph (b) deletes the expression “, the Administration of the Territory” in subsection (2).

Repeals section 21bis of the Merchandise Marks Act, No. 17 of 1941.

RAILWAYS AND HARBOURS PENSIONS AMENDMENT ACT, NO. 26 OF 1941

Amends section 1 of the Railways and Harbours Pensions Amendment Act, No. 26 of 1941, as follows:—paragraph (a) deletes the expression “or South-West Africa” in the definition of “Republic of South Africa”; and paragraph (b) deletes the expression “or the territory of south-west Africa” in the definition of “foreign Black”.

Repeals section 8A of the Railways and Harbours Pensions Amendment Act, No. 26 of 1941.

INSOLVENCY LAW AMENDMENT ACT, NO. 16 OF 1943

Repeals section 38 of the Insolvency Law Amendment Act, No. 16 of 1943.

Substitutes section 39 of the Insolvency Law Amendment Act, No. 16 of 1943.

COMMISSIONS ACT, NO. 8 OF 1947

Amends section 2 of the Commissions Act, No. 8 of 1947, by deleting the expression “or the mandated territory of South-West Africa”.

Amends section 3 (1) of the Commissions Act, No. 8 of 1947, by deleting the expression “, and in the mandated territory of south-west Africa have the powers which the High Court of that territory has”.

Repeals section 6A of the Commissions Act, No. 8 of 1947.

FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK REMEDIES ACT, NO 36 OF 1947

Amends section 1 of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, No. 36 of 1947, by deleting the definition of “Republic”.

Repeals section 24 of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, No. 36 of 1947.

RAILWAYS AND HARBOURS ACTS AMENDMENT ACT, NO. 49 OF 1949

Amends section 16 (2) (a) (iii) of the Railways and Harbours Acts Amendment Act, No. 49 of 1949, by deleting the expression “or of the mandated territory of South-West Africa”.

Amends section 26 of the Railways and Harbours Acts Amendment Act, No. 49 of 1949, as follows:— paragraph (a) substitutes the heading; and paragraph (b) deletes the expression “shall apply to the territory of South-West Africa and”.MERCHANT SHIPPING ACT, NO. 57 OF 1951

Amends section 2 (b) of the Merchant Shipping Act, No. 57 of 1951, by deleting the proviso in the definition of “international voyage”.

Amends section 3 of the Merchant Shipping Act, No. 57 of 1951, by deleting subsection (1).


Amends section 24 of the Railways and Harbours Acts Amendment Act, No. 63 of 1951, as follows:— paragraph (a) substitutes the heading; and paragraph (b) deletes the expression “shall apply to the Territory of South-West Africa and”.

RADIO ACT, NO. 3 OF 1952

Amends section 2 of the Radio Act, No. 3 of 1952, by deleting the expression “and the territory of South-West Africa”.

MERCHANDISE MARKS AMENDMENT ACT, NO. 39 OF 1952

Repeals the Merchandise Marks Amendment Act, No. 39 of 1952.

RAILWAYS AND HARBOURS ACTS AMENDMENT ACTS, NO. 45 OF 1952

Repeals section 13 of the Railways and Harbours Acts Amendment Act, No. 45 of 1952.

WILLS ACT, NO. 7 OF 1953

Amends section 1 of the Wills Act, No. 7 of 1953, by deleting the expression “or the High Court of South-West Africa” in the definition of “Court”.

RAILWAYS AND HARBOURS SPECIAL PENSIONS ACT, NO. 36 OF 1955

Repeals section 8 of the Railways and Harbours Special Pensions Act, No 36 of 1955.

RAILWAY EXPROPRIATION ACT, NO. 37 OF 1955

Repeals section 17 of the Railways Expropriation Act, No. 37 of 1955.

UNIVERSITIES ACT , NO. 61 OF 1955

Amends section 16bis (1) (b) of the Universities Act, No. 61 of 1955, by deleting the

expression “and the territory of South-West Africa”.

VEXATIOUS PROCEEDINGS ACT, NO. 3 OF 1956

Amends section 1 of the Vexatious Proceedings Act, No. 3 of 1956, by deleting the expression “and includes the High Court of South-West Africa” in the definition of “court”.

Amends section 2 (3) of the Vexatious Proceedings Act, No. 3 of 1956, by deleting the expression “and in the Official Gazette of the territory of South-West Africa”.

Repeals section 3 of the Vexatious Proceedings Act, No. 3 of 1956.

RAILWAYS AND HARBOURS ACTS AMENDMENT ACTS, NO. 15 OF 1956


RIOTOUS ASSEMBLIES ACT, NO. 17 OF 1956

Repeals section 19A of the Riotous Assemblies Act, No. 17 of 1956.

FRIENDLY SOCIETIES ACT, NO. 25 OF 1956

Repeals section 52 of the Friendly Societies Act, No. 25 of 1956.

APPORTIONMENT OF DAMAGES ACT, NO. 34 OF 1956

Amends section 4 (2) of the Apportionment of Damages Act, No. 34 of 1956, by deleting the expression “, or under section three of the Administration of Justice Proclamation, 1919 (Proclamation No. 21 of 1919), of the territory of South-West Africa”.

Repeals section 6 of the Apportionment of Damages Act, No. 34 of 1956.

WATER ACT, NO. 54 OF 1956

Amends section 34 (1) (d) of the Water Act, No. 54 of 1956, by deleting the expression “and, for the purposes of the application of the provisions of sections one hundred and six and one hundred and seventy-four, and until the water court referred to in paragraph (g) is established, also in the territory of South-West Africa”.

Amends section 41 (1) of the Water Act, No. 54 of 1956, by deleting the expression “or, in the case of the territory of South-West Africa, of the High Court of South-West Africa,”.

Amends section 49 of the Water Act, No. 54 of 1956, as follows:—paragraph (a) deletes the expression “or in the case of an appeal from the South-West Africa Water Court, of the High Court of South-West Africa,” in subsection (2); and paragraph (b) deletes the expression “or, in the case of the South-West Africa Water Court, of the High Court of South-West Africa” in subsection (3).



STATE ATTORNEY ACT, NO. 56 OF 1957

Amends section 3 (2) of the State Attorney Act, No 56 of 1957, by deleting the expression “, the administration of the territory of South-West Africa”.EXPORT CREDIT AND FOREIGN INVESTMENTS RE-INSURANCE ACT, NO. 78 OF 1957

Amends section 1 of the Export Credit and Foreign Investments Re-insurance Act, No. 78 of 1957, by deleting the definitions of “the Territory” and “the Republic”.

Repeals section 12 of the Export Credit and Foreign Investments Re-insurance Act, No. 78 of 1957.

POLICE AMENDMENT ACT, NO. 43 OF 1958

Repeals section 5 of the Police Amendment Act, No. 43 of 1958.

POST OFFICE ACT, NO. 44 OF 1958

Amends section 12C of the Post Office Act, No 44 of 1958, as follows:—paragraph (a) deletes the expressions “or the Administration of the territory of South-West Africa” and “or the said Administration” wherever they occur in subsections (1) and (2); paragraph (b) substitutes the expression “or a provincial revenue fund” for the expression “, the relevant provincial revenue fund or the revenue fund of the territory of South-West Africa” in subsection (1); and paragraph (c) substitutes the expression “or the relevant provincial revenue fund” for the expression “, the relevant provincial revenue fund or the revenue fund of the territory of South-West Africa” in subsection (2).

WILLS AMENDMENT ACT, NO. 48 OF 1958

Repeals section 2 of the Wills Amendment Act, No. 48 of 1958.

UNIVERSITY OF THE WITWATERSRAND, JOHANNESBURG (PRIVATE) ACT, NO. 15 OF 1959

Amends section 1 of the University of the Witwatersrand, Johannesburg (Private) Act, No. 15 of 1959, by deleting the expression “, of the territory of South-West Africa” in the definition of “health authority”.

UNIVERSITY OF CAPE TOWN ACT, NO. 38 OF 1959 . . . . . .

[Repealed by s. 23 (1) of Act No. 8 of 1999.]



INSURANCE AMENDMENT ACT, NO. 79 OF 1959

Repeals section 25 of the Insurance Amendment Act, No. 79 of 1959.

CHILDREN’S ACT, NO. 33 OF 1960

Amends section 1 of the Children’s Act, No. 33 of 1960, as follows:—paragraph (a) deletes the expression “, and, in relation to the territory, means the Administrator of the territory acting on the advice of the Executive Committee thereto” in the definition of “Administrator” in subsection (1); paragraph (b) deletes the expression “, or of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory, or of the Adoption of Children Ordinance, 1927 (Ordinance No. 10 of 1927), of the territory” in the definition of “adopted child” in subsection (1); paragraph (c) deletes “, or of the Children’s Ordinance, 1961, of the territory, or of the Adoption of Children Ordinance, 1927, of the territory” in the definition of “adoptive parent” in subsection (1); paragraph (d) deletes “, and includes a native within the meaning of section 25 of the Native Administration Proclamation, 1928 (Proclamation No. 15 of 1928), of the territory” in the definition of “Black” in subsection (1); paragraph (e) substitutes “or a provincial education department” for “, a provincial education department or the Administration of the territory” in the definition of “place of care” in subsection (1); paragraph ( f ) deletes the definitions of “Republic” and “territory” in subsection (1); paragraph (g) deletes paragraphs (v), (vi) and (vii) and substitutes the expression “(iii) or (iv)” for the expression “(iii), (iv), (v), (vi) or (vii)” in the definition of “training institution” in subsection (1); and paragraph (h) deletes subsection (2).

Amends section 14 of the Children’s Act, No. 33 of 1960, as follows:—paragraph (a) deletes the expression “, or under the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory, or under the Wives and Children Protection and Maintenance Ordinance, 1927 (Ordinance No. 16 of 1927), of the territory” in paragraph (a); and paragraph (b) deletes the expression “or under Chapter III of the Children’s Ordinance, 1961, of the territory, or under Chapter I of the Wives and Children Protection and Maintenance Ordinance, 1927, of the territory” in paragraph (b).

Amends section 20 (1) of the Children’s Act, No. 33 of 1960, by deleting the expression “or of the Administration of the territory” wherever it occurs.

Amends section 24 (3) of the Children’s Act, No. 33 of 1960, by deleting the expression “or under section 22 (1) of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory”.

Amends section 30 (3) of the Children’s Act, No. 33 of 1960, by deleting the expression “or of the Administration of the territory”.

Amends section 31 (8) of the Children’s Act, No. 33 of 1960, by deleting the expression “or under section 16 (1) of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory”.

Amends section 35 of the Children’s Act, No. 33 of 1960, by deleting subsection (3).

Amends section 52 (1) of the Children’s Act, No. 33 of 1960, by deleting the expression “, or the Education Ordinance, 1962 (Ordinance No. 27 of 1962), of the territory”.

Amends section 63 (2) of the Children’s Act, No. 33 of 1960, by deleting the expressions “or the Native Administration Proclamation, 1928 (Proclamation No. 15 of 1928), of the territory,” and “or the said Proclamation”.

Amends section 69 (1) of the Children’s Act, No. 33 of 1960, by deleting the expression “or the Native Administration Proclamation, 1928 (Proclamation No. 15 of 1928), of the territory”.

Amends section 73 (1) (a) of the Children’s Act, No. 33 of 1960, by deleting the expression “or under section 16 (1) of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory”.

Amends section 82A of the Children’s Act, No. 33 of 1960, by deleting the expression “or in section 25 of the Native Administration Proclamation, 1928 (Proclamation No. 15 of 1928), of the territory,”.

Repeals section 93A of the Children’s Act, No. 33 of 1960.

Amends the First Schedule to the Children’s Act, No. 33 of 1960, by deleting the expression “or under Chapter III of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961), of the territory”.

THE APOSTOLIC FAITH MISSION OF SOUTH AFRICA (PRIVATE) ACT, NO. 24 OF 1961

Amends section 7 of The Apostolic Faith Mission of South Africa (Private) Act, No. 24 of 1961, by deleting the expression “and in the Territory of South-West Africa”.

Repeals section 8A of The Apostolic Faith Mission of South Africa (Private) Act, No. 24 of 1961.

COMMONWEALTH RELATIONS (TEMPORARY PROVISION) ACT, NO. 41 OF 1961

Amends section 1 of the Commonwealth Relations (Temporary Provision) Act, No. 41 of 1961, by deleting the expression “or the territory of South-West Africa.

Repeals section 3 of the Commonwealth Relations (Temporary Provision) Act, No. 41 of 1961.



ARCHIVES ACT, NO. 6 OF 1962

Amends the long title of the Archives Act, No. 6 of 1962, by deleting the expression “and the territory of South-West Africa”.

Amends section 1 of the Archives Act, No. 6 of 1962, as follows:—paragraph (a) deletes the expression “, and any institution in the territory similar to any institution so referred to” in the

definition of “local authority”; paragraph (b) deletes the definitions of “province” and “territory”; and paragraph (c) substitutes the definition of “provincial administration”.

Amends section 8 (1) of the Archives Act, No. 6 of 1962, by deleting the proviso.

Repeals section 15 of the Archives Act, No. 6 of 1962.

CONVENTIONAL PENALTIES ACT, NO. 15 OF 1962

Repeals section 6 of the Conventional Penalties Act, No. 15 of 1962.

HERALDRY ACT, NO. 18 OF 1962

Amends section 1 of the Heraldry Act, No. 18 of 1962, as follows:—paragraph (a) deletes the expression the definitions of “province” and “territory”; paragraph (b) deletes the expression“, the territory” in the definitions of “association” and “institution”; and paragraph (c) deletes the expression “, and any similar institution or body in the territory” in the definition of “municipal”.

Amends section 20 (4) of the Heraldry Act, No. 18 of 1962, by deleting the expression “or the territory”.

Repeals section 27 of the Heraldry Act, No. 18 of 1962.

INCOME TAX ACT, NO. 58 OF 1962

Amends section 10 (1) (t) of the Income Tax Act, No. 58 of 1962, by deleting subparagraph (vii).

Amends section 11bis (1) of the Income Tax Act, No. 58 of 1962, as follows:—paragraph (a) deletes the expression “the territory (including the Eastern Caprivi Zipfel),” in the definition of “exported”; and paragraph (b) deletes the expression ““the territory (including the Eastern Caprivi Zipfel),” in the definition of “export country”.

Amends section 21ter (1) of the Income Tax Act, No. 58 of 1962, by deleting the expression “, or any economic development area falling within the confines of any land or area referred to in section 4 of the South-West Africa Black Affairs Administration Act, 1954 (Act No. 56 of 1954)” in the definition of “Black development area”.

Amends section 36 (11) (d) (vi) (cc) of the Income Tax Act, No. 58 of 1962, by deleting the expressions “or any Income Tax Ordinance of the territory” and “or section 11 (2) (i) of the Income Tax Ordinance, 1961 (Ordinance No. 10 of 1961), of the territory, or the corresponding provisions of any previous Income Tax Ordinance of the territory” in the definition of “capital expenditure incurred”.

Amends section 91 (2) of the Income Tax Act, No. 58 of 1962, by deleting the expression “or the Magistrates’ Courts Ordinance, 1963 (Ordinance No. 29 of 1963), of the territory,”.



EXTRADITION ACT, NO. 67 OF 1962

Amends section 1 of the Extradition Act, No. 67 of 1962, as follows:—paragraph (a) deletes the expression the definition of “the Republic”; and paragraph (b) deletes the expression “and, in relation to the area in the territory of South-West Africa beyond the Police Zone, as defined in section three of the Prohibited Areas Proclamation, 1928 (Proclamation No. 26 of 1928 of that territory), a Commissioner, an Assistant Commissioner and any officer in charge of Black affairs” in the definition of “magistrate”.

Amends section 20 of the Extradition Act, No. 67 of 1962, by deleting the expression “or, in the case of any person surrendered for trial or detention in the territory of South-West Africa, the Administrator thereof”.

Repeals section 22 of the Extradition Act, No. 67 of 1962.

FOREIGN COURTS EVIDENCE ACT, NO. 80 OF 1962

Amends section 1 of the Foreign Courts Evidence Act, No. 80 of 1962, as follows:—paragraph (a) deletes the expression “and, in relation to the area in the territory of South-West Africa beyond the Police Zone, as defined in section three of the Prohibited Areas Proclamation, 1928 (Proclamation No. 26 of 1928 of that territory), a native commissioner, an assistant native commissioner or any officer in charge of native affairs” in the definition of “magistrate”; and paragraph (b) deletes the definition of “Republic”.

Repeals section 12 of the Foreign Courts Evidence Act, No. 80 of 1962.



JUSTICES OF THE PEACE AND COMMISSIONERS OF OATHS ACT, NO. 16 OF 1963

Repeals sections 1 and 11A of the Justices of the Peace and Commissioners of Oaths Act, No. 16 of 1963.

MORATORIUM ACT, NO. 25 OF 1963

Repeals section 7 of the Moratorium Act, No. 25 of 1963.

RECIPROCAL ENFORCEMENT OF MAINTENANCE ORDERS ACT, NO. 80 OF 1963

Amends the long title of the Reciprocal Enforcement of Maintenance Orders Act, No. 80 of 1963, by deleting the expression “, including the territory of South-West Africa,”.

Amends section 1 of the Reciprocal Enforcement of Maintenance Orders Act, No. 80 of 1963, by deleting the definitions of “Republic” and “territory”.

Repeals section 10A of the Reciprocal Enforcement of Maintenance Orders Act, No. 80 of

1963.RAILWAYS AND HARBOURS ACTS AMENDMENT ACT, NO. 54 OF 1964




INSURANCE AMENDMENT ACT, NO. 10 OF 1965

Repeals section 39 of the Insurance Amendment Act, No. 10 of 1965.

PREVENTION OF COUNTERFEITING OF CURRENCY ACT, NO. 16 OF 1965

Amends section 1 of the Prevention of Counterfeiting of Currency Act, No. 16 of 1965, by deleting the definition of “Republic”.

Repeals section 11 of the Prevention of Counterfeiting of Currency Act, No. 16 of 1965.

CIVIL PROCEEDINGS EVIDENCE ACT, NO. 25 OF 1965

Amends the long title of the Civil Proceedings Evidence Act, No. 25 of 1965, by deleting the expression “the Administration of Justice Proclamation, 1919 (South-West Africa), the Further Administration of Justice Proclamation, 1920 (South-West Africa), the Procedure and Evidence Proclamation, 1938 (South-West Africa),”.

Amends section 1 of the Civil Proceedings Evidence Act, No. 25 of 1965, by deleting the definition of “Republic”.

Amends section 5 of the Civil Proceedings Evidence Act, No. 25 of 1965, as follows:—paragraph (a) deletes the expression “or in the Official Gazette of the territory of South-West Africa” in subsection (1); and paragraph (b) deletes the expression “or of the said Official Gazette” in subsection (2).

Amends section 22 (1) of the Civil Proceedings Evidence Act, No. 25 of 1965, by deleting the expression “(including the Administration of South-West Africa)”.

Amends section 27 of the Civil Proceedings Evidence Act, No. 25 of 1965, by deleting the expression “, the Land and Agricultural Bank of South-West Africa”.

Repeals section 43 of the Civil Proceedings Evidence Act, No. 25 of 1965.

ARBITRATION ACT, NO. 42 OF 1965

Amends section 1 of the Arbitration Act, No. 42 of 1965, by deleting the definition of “territory”.

Amends section 14 (1) (a) (iv) of the Arbitration Act, No. 42 of 1965, by deleting the expression “or in the territory”.

Amends section 21 (1) (c) of the Arbitration Act, No. 42 of 1965, by deleting the expression “or in the territory”.

Amends section 37 of the Arbitration Act, No. 42 of 1965, by deleting the expression “or the territory” in paragraphs (b) and (c).

Repeals section 41 of the Arbitration Act, No. 42 of 1965.

ADMINISTRATION OF ESTATES ACT, NO. 66 OF 1965

Amends section 1 of the Administration of Estates Act, No. 66 of 1965, by deleting the definitions of “Republic” and “territory”.

Amends section 5 (1) of the Administration of Estates Act, No. 66 of 1965, by deleting the expression “or in the territory”.

Amends section 12 (5) of the Administration of Estates Act, No. 66 of 1965, by deleting the expression “and in section 156 (1) of the Liquor Ordinance, 1969 (Ordinance No. 2 of 1969), of the territory,”.

Amends section 39 of the Administration of Estates Act, No. 66 of 1965, as follows:—paragraph (a) deletes the expression “and the Deeds Registries Proclamation, 1939 (Proclamation No. 37 of 1939), of the territory,” in subsection (1); and paragraph (b) deletes the expression “and section 25 of the said Proclamation” in subsection (2).

Amends section 44 (3) of the Administration of Estates Act, No. 66 of 1965, by deleting the expressions “, excluding the territory,” and “or in the territory prior to a date twelve months after the date of commencement of the Administration of Estates Amendment Act, 1970”.

Amends section 86 of the Administration of Estates Act, No. 66 of 1965, by deleting subsection (3).

Amends section 94 of the Administration of Estates Act, No. 66 of 1965, by deleting the expression “or section 30 of the Deeds Registries Proclamation, 1939 (Proclamation No. 37 of 1939), of the territory,”.

Amends section 105 (3) of the Administration of Estates Act, No. 66 of 1965, as follows:—paragraph (a) deletes the expression “, excluding the territory,” in paragraph (a); and paragraph (b) deletes paragraph (b).

Repeals section 108A of the Administration of Estates Act, No. 66 of 1965.

IMMOVABLE PROPERTY (REMOVAL OR MODIFICATION OF RESTRICTIONS) ACT, NO. 94 OF 1965

Repeals section 10 of the Immovable Property (Removal or Modification of Restrictions) Act, No. 94 of 1965.

MEDICINES AND RELATED SUBSTANCES CONTROL ACT, NO. 101 OF 1965Amends section 1 (1) of the Medicines and Related Substances Control Act, No. 101 of 1965,

by deleting the definition of “the territory”.

Amends section 6 (1) (d) of the Medicines and Related Substances Control Act, No. 101 of 1965, by deleting the expression “or the territory”.

STATE ATTORNEY AMENDMENT ACT, NO. 7 OF 1966

Repeals sections 6, 7, 8 and 9 of the State Attorney Amendment Act, No. 7 of 1966.



CUSTOMS AND EXCISE AMENDMENT ACT, NO. 57 OF 1966

Amends section 1 of the Customs and Excise Amendment Act, No. 57 of 1966, by deleting subsection (5).

OBSCENE PHOTOGRAPHIC MATTER ACT, NO. 37 OF 1967

Repeals section 4A of the Indecent or Obscene Photographic Matter Act, No. 37 of 1967.

DEFENCE AMENDMENT ACT, NO. 85 OF 1967

Repeals section 70 of the Defence Amendment Act, No. 85 of 1967.



GENERAL LAW AMENDMENT ACT, NO. 102 OF 1967

Amends section 18 of the General Law Amendment Act, No. 102 of 1967, by deleting subsection (2).

PRIZE JURISDICTION ACT, NO. 3 OF 1968

Repeals section 6 of the Prize Jurisdiction Act, No. 3 of 1968.



BLIND PERSONS ACT, NO. 26 OF 1968

Amends section 1 of the Blind Persons Act, No. 26 of 1968, by deleting the definitions of “Republic” and “the territory”.Repeals section 18A of the Blind Persons Act, No. 26 of 1968.

PROMOTION OF THE ECONOMIC DEVELOPMENT OF NATIONAL STATES ACT, NO. 46 OF 1968

Amends section 1 of the Promotion of the Economic Development of National States Act, No. 46 of 1968, by deleting paragraphs (b) and (c) of the definition of “national states”.

Amends section 12 of the Promotion of the Economic Development of National States Act, No. 46 of 1968, by deleting the expression “or the Legislative Assembly of South-West Africa”.

Repeals section 32 of the Promotion of the Economic Development of National States Act, No. 46 of 1968.

ARMAMENTS DEVELOPMENT AND PRODUCTION ACT NO. 57 OF 1968

Amends section 5 (6) of the Armaments Development and Production Act, No. 57 of 1968, by deleting the expression “or the Legislative Assembly of the territory of South-West Africa”.

USURY ACT, NO. 73 OF 1968

Amends section 1 of the Usury Act, No. 73 of 1968, by deleting the definitions of “Republic” and “territory”.

Repeals section 19 of the Usury Act, No. 73 of 1968.

STATE TENDER BOARD ACT, NO. 86 OF 1968

Amends section 4 (3) of the State Tender Board Act, No. 86 of 1968, by deleting subparagraph (a).

ASSESSMENTS OF DAMAGES ACT, NO. 9 OF 1969

Repeals section 2 of the Assessments of Damages Act, No. 9 of 1969.

PROHIBITION OF DISGUISES ACT, NO. 16 OF 1969

Repeals section 3 of the Prohibition of Disguises Act, No. 16 of 1969.

LEASES OF LAND ACT, NO. 18 OF 1969

Repeals section 2 of the Formalities in respect of Leases of Land Act, No. 18 of 1969.

NATIONAL MONUMENTS ACT, NO. 28 OF 1969

Amends section 1 of the National Monuments Act, No. 28 of 1969, by deleting the definitions of “Republic” and “territory”.

Amends section 8 (2) of the National Monuments Act, No. 28 of 1969, by deleting the expression “or section 5 (1) (a) of the Natural and Historical Monuments, Relics and

Antiques Ordinance, 1948 (Ordinance No. 13 of 1948 of the territory),”.

Amends section 19 (2) of the National Monuments Act, No. 28 of 1969, by deleting the expression “, including a law as defined in the Interpretation of Laws Proclamation, 1920 (Proclamation No. 37 of 1920 of the territory),”.

Repeals section 21 of the National Monuments Act, No. 28 of 1969.

CULTURAL INSTITUTIONS ACT, NO. 29 OF 1969

Repeals section 18 of the Cultural Institutions Act, No. 29 of 1969.

LAND BANK AMENDMENT ACT, NO. 31 OF 1969

Repeals the Land Bank Amendment Act, No. 31 of 1969.



UNIVERSITY OF FORT HARE ACT, NO. 40 OF 1969

Amends section 19 of the University of Fort Hare Act, No. 40 of 1969, by substituting the expression “and a provincial administration” for the expression “, a provincial administration and the Administration of the territory South-West Africa”.

SECOND RAILWAYS AND HARBOURS ACTS AMENDMENT ACT, NO. 41 OF 1969

Repeals section 13 of the Second Railways and Harbours Acts Amendment Act, No. 41 of 1969.


Amends the long title of the Income Tax Act, No. 89 of 1969, by deleting the expressions “and the Revenue Fund of the territory of South-West Africa” and “to amend the Income Tax Ordinance, 1961, of the territory of South-West Africa”.

Amends section 1 of the Income Tax Act, No. 89 of 1969, as follows:— paragraph (a) adds the word “and” at the end of subsection (1) (a); paragraph (b) deletes the word “and” at the end of subsection (1) (b); paragraph (c) deletes subsection (1) (c); and paragraph (d) deletes subsection (2).

Repeals section 3 of the Income Tax Act, No. 89 of 1969.

Amends section 50 (a) of the Income Tax Act, No. 89 of 1969, by deleting the expression “or, in the case of any other company which has carried on any trade or derived any amount in the territory of South-West Africa, from the commencement of the first financial year of such company under the principal Act which ended after the thirtieth day of June, 1968”.

Repeals sections 51, 52, 53, 54 and 55 of the Income Tax Act, No. 89 of 1969.

Amends the Schedule to the Income Tax Act, No. 89 of 1969, as follows:—paragraph (a) deletes paragraph 2 (b) (i) and paragraph 2 (g) (i); paragraph (b) deletes the expression “elsewhere than within the said territory,” in paragraph 2 (b) (ii) and paragraph 2 (g) (ii); and paragraph (c) deletes paragraph 4.

MEMBERS OF STATUTORY BODIES PENSION ACT, NO. 94 OF 1969

Amends section 1 of the Members of Statutory Bodies Pension Act, No. 94 of 1969, as follows:—paragraph (a) deletes the expression “or of the Legislative Assembly of the territory” and “or by the Legislative Assembly of the territory” in the definition of “statutory body”; and paragraph (b) deletes the definition of “the territory”.

Amends section 2 (3) (a) of the Members of Statutory Bodies Pension Act, No. 94 of 1969, by deleting the expression “, or from the Territory Revenue Fund, as the case may be”.

Repeals section 7 of the Members of Statutory Bodies Pension Act, No. 94 of 1969.


Repeals section 41 of the Customs and Excise Amendment Act, No. 105 of 1969.

THE APOSTOLIC FAITH MISSION OF SOUTH AFRICA (PRIVATE) AMENDMENT ACT, NO. 4 OF 1970

Amends the long title of The Apostolic Faith Mission of South Africa (Private) Amendment Act, No. 4 of 1970, by substituting the expression “substitute an obsolete expression” for the expression “apply the provisions of the Act to the Territory of South-West Africa, and to make provision for incidental matters”.

Amends the preamble to The Apostolic Faith Mission of South Africa (Private) Amendment Act, No. 4 of 1970, by deleting the expressions “AND WHEREAS the said Act does not apply to the Territory of South-West Africa;” and “AND WHEREAS it is desirable that the provisions of the said Act should be applied also to the Territory of South-West Africa;”.

Repeals sections 1 and 2 of The Apostolic Faith Mission of South Africa (Private) Amendment Act, No. 4 of 1970.

ARCHITECTS’ ACT, NO. 35 OF 1970

Amends section 3 (2) (a) of the Architects’ Act, No. 35 of 1970, by deleting the expression “, and one person who shall be selected by the Minister from among the persons who immediately prior to such commencement were members of the Executive Committee of the Institute of South-West African Architects in terms of the Architects Ordinance, 1952 (Ordinance No. 38 of 1952), of South-West Africa”.

Amends section 19 (5) (a) of the Architects’ Act, No. 35 of 1970, by deleting the expression “or the Architects Ordinance, 1952 (Ordinance No. 38 of 1952), of South-West Africa,”.

Amends section 22 (2) of the Architects’ Act, No. 35 of 1970, by deleting the expression “or

the Architects Ordinance, 1952 (Ordinance No. 38 of 1952), of South-West Africa,”.

Amends section 34 of the Architects’ Act, No. 35 of 1970, by deleting subsection (5).

QUANTITY SURVEYORS’ ACT, NO. 36 OF 1970

Amends section 1 of the Quantity Surveyors’ Act, No. 36 of 1970, as follows:—paragraph (a) deletes the expression “the South-West Africa Administration,” in the definition of “in the service of the State”; and paragraph (b) deletes the definition of “Republic”.

Amends section 3 (2) (a) of the Quantity Surveyors’ Act, No. 36 of 1970, by deleting the expression “from among the persons who immediately prior to such commencement were, in terms of the Quantity Surveyors Ordinance, 1959 (Ordinance No. 36 of 1959), of South-West Africa members of the Executive Committee of the Institute of South-West African Quantity Surveyors.”.

Amends section 19 (5) of the Quantity Surveyors’ Act, No. 36 of 1970, by deleting the expression “or was registered as a quantity surveyor in terms of the Quantity Surveyors Ordinance, 1959 (Ordinance No. 36 of 1959), of South-West Africa,”.

Amends section 22 (2) of the Quantity Surveyors’ Act, No. 36 of 1970, by deleting the expression “or was registered as a quantity surveyor in terms of the Quantity Surveyors Ordinance, 1959 (Ordinance No. 36 of 1959), of South-West Africa,”.

Repeals section 34 of the Quantity Surveyors’ Act, No. 36 of 1970.

RECIPROCAL ENFORCEMENT OF MAINTENANCE ORDERS AMENDMENT ACT, NO. 40 OF 1970

Repeals section 8 of the Reciprocal Enforcement of Maintenance Orders Amendment Act, No. 40 of 1970.

WINE AND SPIRIT CONTROL ACT, NO. 47 OF 1970

[Repealed by s. 58D of Act No. 47 of 1970.]


Amends the long title of the Income Tax Act, No. 52 of 1970, by deleting the expression “and the Revenue Fund of the territory of South-West Africa”.

Repeals sections 3 and 30 of the Income Tax Act, No. 52 of 1970.

Amends Schedule 1 to the Income Tax Act, No. 52 of 1970, as follows:—paragraph (a) deletes paragraph 1 (b) (i) and paragraph 1 (g) (i); and paragraph (b) deletes the expression “elsewhere than within the said territory,” in paragraph 1 (b) (ii) and paragraph 1 (g) (ii).

ADMINISTRATION OF ESTATES AMENDMENT ACT, NO. 54 OF 1970

Amends section 11 of the Administration of Estates Amendment Act, No. 54 of 1970, by

deleting subsections (1) and (3).

Repeals the Schedule to the Administration of Estates Amendment Act, No. 54 of 1970.

JUSTICES OF THE PEACE AND COMMISSIONERS OF OATHS AMENDMENT ACT, NO. 55 OF 1970

Repeals section 4 of and the Schedule to the Justices of the Peace and Commissioners of Oaths Amendment Act, No. 55 of 1970.



MOUNTAIN CATCHMENT AREAS ACT, NO. 63 OF 1970

Repeals section 19 of the Mountain Catchment Areas Act, No. 63 of 1970.

AGRICULTURAL CREDIT AMENDMENT ACT, NO. 66 OF 1970

Amends section 20 of the Agricultural Credit Amendment Act, No. 66 of 1970, as follows:—paragraph (a) deletes the expression “the Administrator of South-West Africa” in subsection (2); and paragraph (b) deletes subsection (3).

Repeals section 21 of the Agricultural Credit Amendment Act, No. 66 of 1970.

Amends section 23 of the Agricultural Credit Amendment Act, No. 66 of 1970, by deleting the expression “(including the Administration of the territory)”.

SUBDIVISION OF AGRICULTURAL LAND ACT, NO. 70 OF 1970

Amends section 1 of the Subdivision of Agricultural Land Act, No. 70 of 1970, as follows:—paragraph (a) deletes the expression “and, in South-West Africa, a peri-urban area established under section 9 of the Peri-Urban Development Board Ordinance, 1970 (Ordinance No. 19 of 1970 of South-West Africa),” in paragraph (a) of the definition of “agricultural land”; paragraph (b) deletes the expressions “or the administration of the territory of South-West Africa” and “or the Administrator of the said territory” in paragraph (c) of the definition of “agricultural land”; paragraph (c) deletes the expression “or the territory of South-West Africa” in the definition of “executive committee; and paragraph (d) deletes the expression “or an ordinance of the territory of South-West Africa” in the definition of “scheme”.

Amends section 2 (a) (i), (ii) and (iii) of the Subdivision of Agricultural Land Act, No. 70 of 1970, by deleting the expression “or the administration of the territory of South-West Africa”.Amends section 4 (2) (b) of the Subdivision of Agricultural Land Act, No. 70 of 1970, by deleting the expression “, including the territory of South-West Africa,”.

Amends section 13 of the Subdivision of Agricultural Land Act, No. 70 of 1970, as follows:—paragraph (a) deletes the expression “or an ordinance of the territory of South-West Africa” in subsection (1); and paragraph (b) deletes the expression “(including the

Administrator of the territory of South-West Africa)” in subsection (2).

Repeals section 14 of the Subdivision of Agricultural Land Act, No. 70 of 1970.

NATIONAL SUPPLIES PROCUREMENT ACT, NO. 89 OF 1970

Amends section 1 of the National Supplies Procurement Act, No. 89 of 1970, by deleting the definition of “Republic”.

Repeals section 19 of the National Supplies Procurement Act, No. 89 of 1970.

LIMITATION OF LEGAL PROCEEDINGS (PROVINCIAL AND LOCAL AUTHORITIES) ACT, NO. 94 OF 1970

Amends the long title of the Limitation of Legal Proceedings (Provincial and Local Authorities) Act, No. 94 of 1970, by deleting the expression “the Administration of the territory of South-West Africa,”.

Amends section 1 of the Limitation of Legal Proceedings (Provincial and Local Authorities) Act, No. 94 of 1970, as follows:—paragraph (a) deletes the expression “or of the territory of South-West Africa” in the definition of “administration”; and paragraph (b) deletes the expression “, and any municipality or village management board established or constituted or deemed to be established or constituted under the Municipal Ordinance, 1963 (Ordinance No. 13 of 1963, of the territory of South-West Africa), or the Village Management Boards Ordinance, 1963 (Ordinance No. 14 of 1963, of the territory of South-West Africa)” in the definition of “local authority”.

Repeals section 7 of the Limitation of Legal Proceedings (Provincial and Local Authorities) Act, No. 94 of 1970.



BLACK AUTHORITIES’ SERVICE PENSIONS ACT, NO. 6 OF 1971

Amends section 1 (1) of the Black Authorities’ Service Pensions Act, No. 6 of 1971, as follows:— paragraph (a) (i) adds the word “or” at the end of paragraph (a) of the definition of “authority”, paragraph (a) (ii) deletes paragraph (b) of the definition of “authority”; paragraph (b) deletes the expression “and the administration of the territory” in the definition of “Government”; paragraph (c) deletes the expression “or the territory and includes any proclamation issued by the Administrator of the territory” in the definition of “ordinance”; paragraph (d) substitutes the expression “or the provincial revenue fund of the province concerned” for the expression “, the provincial revenue fund of the province concerned or the Revenue Fund of the territory” in paragraph (d) (i) of the definition of “revenue”; and paragraph (e) deletes the definition of “the territory”.

Repeals section 8 of the Black Authorities’ Service Pensions Act, No. 6 of 1971.

BLIND PERSONS AMENDMENT ACT, NO. 16 OF 1971

Amends the long title of the Blind Persons Amendment Act, No. 16 of 1971, by deleting the expression “to repeal the Social Pensions Ordinance, 1965, of that territory in certain respects;”.

Repeals sections 7, 8 and 9 of the Blind Persons Amendment Act, No. 16 of 1971.



WATER RESEARCH ACT, NO. 34 OF 1971

Repeals section 15 of the Water Research Act, No. 34 of 1971.

SURETYSHIP AMENDMENT ACT, NO. 57 OF 1971

Repeals section 4 of the Suretyship Amendment Act, No. 57 of 1971.




Amends the long title of the Income Tax Act, No. 88 of 1971, by deleting the expression “to provide for the payment of a portion of the normal tax payable by certain companies into the Revenue Fund of the territory of South-West Africa;”.


Amends paragraph 1 of the Schedule to the Income Tax Act, No. 88 of 1971, as follows:—paragraph (a) deletes subparagraphs 1 (b) (i) and (g) (i); and paragraph (b) deletes the expression “elsewhere than within the said territory,” in subparagraphs 1 (b) (ii) and (g) (ii).


Amends section 3 of the Customs and Excise Amendment Act, No. 89 of 1971, by deleting subsection (2).RAILWAYS AND HARBOURS ACTS AMENDMENT ACT, NO. 33 OF 1972


AGE OF MAJORITY ACT, NO. 57 OF 1972

Repeals section 8 of the Age of Majority Act, No. 57 of 1972.


Amends the long title of the Income Tax Act, No. 90 of 1972, by deleting the expression “to provide for the payment of a portion of the normal tax payable by certain companies into the Revenue Fund of the territory of South-West Africa;” and “to amend certain provisions of the Income Tax Ordinance, 1961, of South-West Africa;”.

Repeals sections 2, 32, 33 and 35 of the Income Tax Act, No. 90 of 1972.

Amends paragraph 1 of Schedule 1 to the Income Tax Act, No. 90 of 1972, as follows:—paragraph (a) deletes subparagraphs 1 (b) (i) and (g) (i); and paragraph (b) deletes the expression “elsewhere than within the said territory” in subparagraphs 1 (b) (ii) and (g) (ii).

MENTAL HEALTH ACT, NO. 18 OF 1973

Amends section 1 (1) of the Mental Health Act, No. 18 of 1973, by deleting the definitions of “province” and “Republic”.

Amends section 9 (3) of the Mental Health Act, No. 18 of 1973, by substituting the expression “and the Educational Services Act, 1967 (Act No. 41 of 1967),” for the expression “the Educational Services Act, 1967 (Act No. 41 of 1967), the Coloured Persons in South West Africa Education Act, 1972 (Act No. 63 of 1972), the Basters of Rehoboth Education Act, 1972 (Act No. 85 of 1972), and the Nama in South West Africa Education Act, 1972 (Act No. 86 of 1972)”.

Amends section 40 (c) of the Mental Health Act, No. 18 of 1973, by deleting the expression “, or established under section 37 of the Children’s Ordinance, 1961 (Ordinance No. 31 of 1961 of South West Africa)”.

Repeals section 78 of the Mental Health Act, No. 18 of 1973.

SOUTH AFRICAN LAW COMMISSION ACT, NO. 19 OF 1973

Amends section 1 of the South African Law Commission Act, No. 19 of 1973, by deleting the definition of “Republic”.

SOCIAL PENSIONS ACT, NO. 37 OF 1973

Amends section 1 of the Social Pensions Act, No. 37 of 1973, by deleting the definitions of “Republic” and “the territory”.

Amends section 19 of the Social Pensions Act, No. 37 of 1973, by deleting the expression “outside the territory”.

Repeals section 20 of the Social Pensions Act, No. 37 of 1973.

SEA BIRDS AND SEALS PROTECTION ACT, NO. 46 OF 1973

Amends section 1 of the Sea Birds and Seals Protection Act, No. 46 of 1973, by deleting the definition of “Republic”.

Amends section 9 (2) (a) of the Sea Birds and Seals Protection Act, No. 46 of 1973, by deleting the expression “or the territory of South-West Africa”.

Amends section 16 (1) of the Sea Birds and Seals Protection Act, No. 46 of 1973, as follows:—paragraph (a) deletes paragraph (a); and paragraph (b) deletes the expression “of the Nature Conservation Ordinance, 1967 (Ordinance No. 31 of 1967 of South West Africa), or” in paragraph (b).

Amends Schedule 1 to the Sea Birds and Seals Protection Act, No. 46 of 1973, by substituting the word “Namibia” for the expression “South-West Africa”, wherever it occurs.



GOVERNMENT SERVICE PENSION ACT, NO. 57 OF 1973

Amends the long title of the Government Service Pension Act, No. 57 of 1973, by deleting the expression “or of the Administration of the territory of South-West Africa”.

Amends section 1 of the Government Service Pension Act, No. 57 of 1973, as follows:—paragraph (a) deletes the expression “or the Administration of the territory” in the definition of “administration”; paragraph (b) deletes the expression “or the Administrator of the territory” in the definition of “Administrator”; paragraph (c) deletes the expression “and the territory” in the definition of “previous fund”; paragraph (d) deletes the expression “, or in section 1 of that Act as modified and applied to the territory by Proclamation No. 271 of 1959” in the definition of “prisons service”; paragraph (e) deletes the definitions of “Republic” and “the territory”; and paragraph ( f ) deletes paragraph (c) of the definition of “revenue”.

Amends section 6 (7) of the Government Service Pension Act, No. 57 of 1973, by deleting the expression “or of the territory”.

Repeals section 19 of the Government Service Pension Act, No. 57 of 1973.


Amends the long title of the Income Tax Act, No. 65 of 1973, by deleting the expression “to provide for the payment of a portion of the normal tax payable by certain companies into the Revenue Fund of the territory of South-West Africa;”.Repeals sections 2 and 43 of the Income Tax Act, No. 65 of 1973.

Amends paragraph 1 of the Schedule to the Income Tax Act, No. 65 of 1973, as follows:—paragraph (a) deletes subparagraphs (b) (i) and (g) (i); and paragraph (b) deletes the expression “elsewhere than within the said territory,” in subparagraphs (b) (ii) and (g) (ii).

MEASURING UNITS AND NATIONAL MEASURING STANDARDS ACT, NO. 76 OF 1973

Amends the long title of the Measuring Units and National Measuring Standards Act, No. 76

of 1973, by deleting the expression “and South-West Africa”.

Amends section 1 of the Measuring Units and National Measuring Standards Act, No. 76 of 1973, by deleting the definition of “Republic”.

Repeals section 9 of the Measuring Units and National Measuring Standards Act, No. 76 of 1973.

Amends section 10 of the Measuring Units and National Measuring Standards Act, No. 76 of 1973, by deleting the expression “and the administration of the territory of South-West Africa”.

INTERNATIONAL HEALTH REGULATIONS ACT, NO. 28 OF 1974

Amends section 1 of the International Health Regulations Act, No. 28 of 1974, by deleting the definition of “Republic”.

Repeals section 5 of the International Health Regulations Act, No. 28 of 1974.



POST OFFICE SERVICE ACT, NO. 66 OF 1974

Amends section 1 of the Post Office Service Act, No. 66 of 1974, by deleting the definitions of “Republic” and “the territory”.

Amends section 16 (3) and (4) of the Post Office Service Act, No. 66 of 1974, by deleting the expression “, the administration of the territory”.

Amends section 23 (b), ( f ) and (r) of the Post Office Service Act, No. 66 of 1974, by deleting the expression “or the administration of the territory”.

Amends section 38 (6) of the Post Office Service Act, No. 66 of 1974, by deleting the expression “, the administration of the territory”.





ABORTION AND STERILIZATION ACT, NO. 2 OF 1975

Repeals section 11 of the Abortion and Sterilization Act, No. 2 of 1975.









ABORTION AND STERILIZATION AMENDMENT ACT, NO. 18 OF 1976

Repeals the Abortion and Sterilization Amendment Act, No. 18 of 1976.

NATIONAL PARKS ACT, NO. 57 OF 1976

Amends Schedule 1 to the National Parks Act, No. 57 of 1976, by substitutes the word “Namibia” for the expression “South-West Africa” in the definition of the Area of the Kalahari Gemsbok National Park.

BROADCASTING ACT, NO. 73 OF 1976

Repeals section 31 of the Broadcasting Act, No. 73 of 1976.

MILITARY PENSIONS ACT, NO. 84 OF 1976Amends section 1 of the Military Pensions Act, No. 84 of 1976, by deleting the definition of “Republic”.

Repeals section 25 of the Military Pensions Act, No. 84 of 1976.

WAR DAMAGE INSURANCE AND COMPENSATION ACT, NO. 85 OF 1976

Amends section 2 (b) of the War Damage Insurance and Compensation Act, No. 85 of 1976, by deleting the expression “or in the territory of South-West Africa”.

Repeals section 12 of the War Damage Insurance and Compensation Act, No. 85 of 1976.


Repeals section 3 of the Second Railways and Harbours Acts Amendment Act, No. 89 of 1976


Amends the long title of the Income Tax Act, No. 103 of 1976, as follows:—paragraph (a) deletes the expression “to provide for the payment of a portion of the normal tax payable by certain companies into the Revenue Fund of the territory of South-West Africa;”; and paragraph (b) substitutes the expression “and the Income Tax Act, 1974” for the expression “the Income Tax Act, 1974, and the Income Tax Ordinance, 1974, of the said territory”.



ESTATE AGENTS ACT, NO. 112 OF 1976

Amends section 1 of the Estate Agents Act, No. 112 of 1976, by deleting the definition of “Republic”.

Repeals section 36 of the Estate Agents Act, No. 112 of 1976.

FINANCE AND FINANCIAL ADJUSTMENTS ACTS CONSOLIDATION ACT, NO. 11 OF 1977

Amends section 5 (1) of the Finance and Financial Adjustments Acts Consolidation Act, No. 11 of 1977, by deleting the expression “or the administration of South-West Africa”.

Amends section 9 of the Finance and Financial Adjustments Acts Consolidation Act, No. 11 of 1977, as follows:—paragraph (a) deletes the expression “a legislative council or authority established or recognized under the Development of Self-government for Native Nations in South-West Africa Act, 1968 (Act 54 of 1968),” in subsection (1); and paragraph (b) deletes subsection (2).

Repeals sections 21, 41 and 47 of the Finance and Financial Adjustments Acts Consolidation Act, No. 11 of 1977.

Amends section 25 (1) (a) of the Finance and Financial Adjustments Acts Consolidation Act, No. 11 of 1977, by deleting the expression “or the administration of South-West Africa”.

INQUESTS AMENDMENT ACT, NO. 46 OF 1977

Repeals section 3 of the Inquests Amendment Act, No. 46 of 1977.

CRIMINAL PROCEDURE ACT, NO. 51 OF 1977

Amends section 1 (1) of the Criminal Procedure Act, No. 51 of 1977, by deleting the definitions of “law”, “province”, “provincial administration”, “Republic”, “State” and “territory”.

Amends section 117 of the Criminal Procedure Act, No. 51 of 1977, by deleting the expressions “or an ordinance of the Legislative Assembly of the territory” and “or of the Administrator of the Territory”.

Amends section 195 (1) (g) of the Criminal Procedure Act, No. 51 of 1977, by deleting the expression “, or in the case of the territory, of any provision of section 3 or 4 of the Girls’ and Mentally Defective Women’s Protection Proclamation, 1921 (Proclamation 28 of 1921), or of section 3 of the Immorality Proclamation, 1934 (Proclamation 19 of 1934)”.

Amends section 204 (4) (b) of the Criminal Procedure Act, No. 51 of 1977, by deleting the expression “, or on the case of the territory, for a contravention of section 300 (3) of the Criminal Procedure Ordinance, 1963 (Ordinance 34 of 1963), arising likewise”.

Amends section 224 (a) of the Criminal Procedure Act, No. 51 of 1977, by deleting the expression “or the territory”.

Amends section 250 (2) (a) of the Criminal Procedure Act, No. 51 of 1977, by deleting the expression “or the Revenue Fund of the territory”.

Amends section 260 of the Criminal Procedure Act, No. 51 of 1977, as follows:— paragraph (a) adds the word “or” at the end of paragraph (e); paragraph (b) deletes the word “or” at the end of paragraph ( f ); and paragraph (c) deletes paragraph (g).

Amends section 264 of the Criminal Procedure Act, No. 51 of 1977, as follows:— paragraph (a) adds the word “or” at the end of paragraph (b); paragraph (b) deletes the word “or” at the end of paragraph (c); and paragraph (c) deletes paragraph (d).

Amends section 265 of the Criminal Procedure Act, No. 51 of 1977, as follows:— paragraph (a) adds the word “or” at the end of paragraph (a); paragraph (b) deletes the word “or” at the end of paragraph (b); and paragraph (c) deletes paragraph (c).

Repeals section 343 of the Criminal Procedure Act, No. 51 of 1977.

Amends section 345 of the Criminal Procedure Act, No. 51 of 1977, by deleting the expression “and may fix different dates for the commencement of any such provision in the Republic, the territory and the Eastern Caprivi Zipfel”.



AGRICULTURAL CREDIT AMENDMENT ACT, NO. 81 OF 1977

Amends section 1 of the Agricultural Credit Amendment Act, No. 81 of 1977, by deleting subsection (3).





PATENTS ACT, NO. 57 OF 1978

Amends section 2 of the Patents Act, No. 57 of 1978, by substituting the definition of “‘law society’ means a law society referred to in section 56 of the Attorneys Act, 1979 (Act No. 53 of 1979);” for the definition of “law society”.




Amends section 1 (b) of the Income Tax Act, No. 101 of 1978, by deleting the expression “elsewhere than in the territory of South-West Africa”.

ATTORNEYS ACT, NO. 53 OF 1979

Amends section 83 of the Attorneys Act, No. 53 of 1979, as follows:—paragraph (a) deletes the expressions “in the Republic, excluding the Territory,” and “or, in the Territory, to any board of executors or trust company licensed as such on or before 1 May 1960 under the Licenses Consolidation Ordinance, 1935 (Ordinance No. 13 of 1935, of the Territory),” in subsection (11) (a); paragraph (b) (i) deletes the word “or” at the end of subsection (11) ( f ) (i); paragraph (b) (ii) deletes subsection (11) ( f ) (ii); paragraph (b) (iii) deletes the expression “in the Republic excluding the Territory, in the case of a person referred to in subparagraph (i), or in the Territory, in the case of a person referred to in subparagraph (ii)” in subsection (11) ( f ); paragraph (c) deletes the expressions “in the Republic excluding the Territory,” and “or in the Territory to any accountant who on 1 May 1960,” in subsection (11) (g); paragraph (d) deletes the expression “the Territory or” in subsection (12) (c); paragraph (e) (i) deletes the word “or” at the end of subsection (12) (e) (i); paragraph (e) (ii) deletes subsection (12) (e) (ii); and paragraph (e) (iii) deletes the expression “in the Republic excluding the Territory, in the case of a person referred to in subparagraph (i), or in the Territory, in the case of a person referred to in subparagraph (ii),” in subsection (12).

Repeals section 85 of the Attorneys Act, No. 53 of 1979.

TEMPORARY EMPLOYEES PENSION FUND ACT, NO. 75 OF 1979

Repeals section 9A of the Temporary Employees Pension Fund Act, No. 75 of 1979.















SOUTH AFRICAN TRANSPORT SERVICES AMENDMENT ACT, NO. 6 OF 1982

Repeals section 21 of the South African Transport Services Amendment Act, No. 6 of 1982.





UNIVERSITIES AMENDMENT ACT, NO. 83 OF 1983

Amends section 5 of the Universities Amendment Act, No. 83 of 1983, by deleting paragraph (e).



SECOND SOUTH AFRICAN TRANSPORT SERVICES AMENDMENT ACT, NO. 93 OF 1984

Repeals section 3 of the Second South African Transport Services Amendment Act, No. 93 of 1984.

MEMBERS OF PARLIAMENT AND POLITICAL OFFICE-BEARERS PENSION SCHEME ACT, NO. 112 OF 1984

Amends section 1 of the Members of Parliament and Political Office-bearers Pension Scheme Act, No. 112 of 1984, by deleting the definition of “Administrator-General”.

Amends section 3 (1) (a) (ii) of the Members of Parliament and Political Office-bearers Pension Scheme Act, No. 112 of 1984, by deleting the expression “, Administrator-General”.





MOTOR VEHICLE ACCIDENTS FUND ACT, NO. 84 OF 1986 . . . . . .

[Repealed by s. 27 (1) (b) of Act No. 56 of 1996.]



SEA FISHERY ACT, NO. 12 OF 1988 . . . . . .

[Repealed by s. 84 of Act No. 18 of 1998.]

MUNICIPAL ACCOUNTANTS ACT, NO. 21 OF 1988

Amends section 4 (4) of the Municipal Accountants Act, No. 21 of 1988, by deleting the expression “or from the territory of South-West Africa”.

SCIENTIFIC RESEARCH COUNCIL ACT, NO. 46 OF 1988

Amends section 1 of the Scientific Research Council Act, No. 46 of 1988, by deleting the definition of “Republic”.

Repeals section 21 of the Scientific Research Council Act, No. 46 of 1988.

MULTILATERAL MOTOR VEHICLE ACCIDENTS FUND ACT, NO. 93 OF 1989 . . . . . .

[Repealed by s. 27 (1) (b) of Act No. 56 of 1996.]

MIER RURAL AREA ACT (HOUSE OF REPRESENTATIVES), NO. 90 OF 1990

Amends Schedule 2 to the Mier Rural Area Act (House of Representatives), No. 90 of 1990, by substituting the word “Namibia” for the expression “South-West Africa”.




Repealed Act Act 3 of 1952 has been repealed by s 103 of Act 103 of 1996Repealed Act Act 103 of 1996 has been repealed by s 97 of Act 36 of 2005







Repealed Act Act 54 of 1956 has been repealed by s 163(1) of Act 36 of 1998

































Repealed Act

Act 37 of 1967 has been repealed by s 33 of Act 65 of 1996










Repealed Act Act 46 of 1968 has been repealed by s 27A of Act 108 of 1991 Repealed Act Act 46 of 1968 has been repealed by s 27A of Act 108 of 1991

Repealed Act Act 46 of 1968 has been repealed by s 27A of Act 108 of 1991





Repealed Act




Repealed Act Act 73 of 1968 has been repealed by s 172 (4) of Act 34 of 2005






























































Repealed Act Act 6 of 1971 has been repealed by s 34 of P 21 of 1996

















Repealed Act

















Repealed Act



































MEDICINES AND RELATED SUBSTANCES AMENDMENT ACTNO. 59 OF 2002

[ASSENTED TO 30 DECEMBER, 2002][DATE OF COMMENCEMENT: 2 MAY, 2003]

(English text signed by the President)

This Act has been updated to Government Gazette 24627 dated 28 March, 2003.

ACTTo amend the Medicines and Related Substances Act, 1965, so as to provide for some definitions; to provide for the appointment of one or more Deputy Registrars; to provide for a term of office of members of the Pricing Committee; to provide for the delay of the coming into operation of provisions requiring a licence before a person can compound and dispense or manufacture medicines, or act as a wholesaler or distributor; to provide for appeals against the decisions of the Director-General and the council; to provide for regulations relating to the marketing of medicines; and to provide for matters connected therewith.

BE IT ENACTED by the Parliament of the Republic of South Africa, as follows:—

1. Amends section 1 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) inserts the definition of “magistrate”; and paragraph (b) substitutes the definition of “practitioner”.

2. Amends section 6 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) deletes subsection (2) (b); and paragraph (b) substitutes subsection (3).

3. Substitutes section 12 of the Medicines and Related Substances Act, No. 101 of 1965.

4. Substitutes section 18C of the Medicines and Related Substances Act, No. 101 of 1965.

5. Amends section 22A of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (6) (p); paragraph (b) substitutes subsection (8); paragraph (c) substitutes subsection (9) (a) (i); paragraph (d) substitutes subsection (11) (a); paragraph (e) substitutes subsection (12) (a) (i); paragraph ( f ) substitutes subsection (12) (b); paragraph (g) substitutes subsection (12) (c); paragraph (h) substitutes subsection (14) (a); and paragraph (i) substitutes subsection (16) (b).

6. Amends section 22C of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1) (b); paragraph (b) substitutes subsection (2); paragraph (c) substitutes subsection (5); paragraph (d) substitutes subsection (6); and paragraph (e) substitutes subsection (7).

7. Amends section 22F (1) of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes the words preceding paragraph (a); and paragraph (b) substitutes paragraph (a).

8. Amends section 22G of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); paragraph (b) adds subsection (2) (c); and paragraph (c) substitutes subsection (3) (b).

9. Amends section 24 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes the heading; paragraph (b) substitutes subsection (1); paragraph (c) substitutes subsection (2) (a); paragraph (d) substitutes subsection (3); paragraph (e) substitutes subsection (4); paragraph ( f ) substitutes subsection (6); and paragraph (g) adds subsection (7).

10. Substitutes section 25 of the Medicines and Related Substances Act, No. 101 of 1965.11. Amends section 28 of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes subsection (1); and paragraph (b) adds subsections (5) and (6).

12. Amends section 35 (1) of the Medicines and Related Substances Act, No. 101 of 1965, as follows:—paragraph (a) substitutes paragraph (xxiv); and paragraph (b) substitutes paragraph (xxvii).

13. Substitutes the long title of the Medicines and Related Substances Act, No. 101 of 1965.

14. Repeal of Act 132 of 1998.—The South African Medicines and Medical Devices Regulatory Authority Act, 1998 (Act No. 132 of 1998), is repealed.



15. Short title and commencement.—This Act is called the Medicines and Related Substances Amendment Act, 2002, and shall come into operation on a date to be determined by the President by proclamation in the Gazette.

MEDICINES AND RELATED SUBSTANCES ACT101 OF 1965

TABLE OF CONTENTS

PROPOSED REGULATIONS

GN 2007 of 9 December 2005Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances(Government Gazette No. 28308)

GN 449 of 31 March 2006Amends Regulations relating to a transparent pricing system for medicine and scheduled substances(Government Gazette No. 28673)

GNR.623 of 30 June 2006Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee(Government Gazette No. 28947)

GNR.1211 of 1 December 2006Methodology for International Benchmarking of the Prices of Medicines and Scheduled Substances in South Africa(Government Gazette No. 29443)

GNR.919 of 2 October 2007Regulations relating to a transparent pricing system for medicines and scheduled substances(Government Gazette No. 30342)

GN 807 of 29 July 2008Annual review of the single exit prices of medicines and scheduled substances(Government Gazette No. 31288)

GN 848 of 11 August 2008Annual review of the single exit prices of medicines and scheduled substances(Government Gazette No. 31327)

GNR.868 of 22 August 2008General regulations(Government Gazette No. 31334)

GNR.869 of 22 August 2008Regulations relating to complementary and alternative medicines(Government Gazette No. 31334)

GNR.870 of 22 August 2008Schedules on complementary and alternative medicines in terms of the Act(Government Gazette No. 31334)

GNR.899 of 25 August 2008Determination of an appropriate logistic fee for medicines and scheduled substances

(Government Gazette No. 31357)

GN 1053 of 29 August 2008Call for comment on a methodology for international benchmarking of originator medicine prices(Government Gazette No. 31369)

GNR.967 of 12 September 2008Determination of an appropriate logistic fee for medicines and scheduled substances(Government Gazette No. 31404)

GN 1212 of 30 September 2008Regulations:Transparent pricing system for medicines and scheduled substances: Amendment(Government Gazette No. 31466)

GNR.195 of 23 February 2009Regulations relating to the Transparent Pricing System for Medicines and Scheduled Substances: Amendment(Government Gazette No. 31947)

GNR.688 of 19 June 2009Regulations: Transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment(Government Gazette No. 32330)

GN 1474 of 6 November 2009Annual review of the single exit prices of medicines and scheduled substances: Invitation to submit representations(Government Gazette No. 32684)

GNR.1053 of 6 November 2009Regulations relating to a transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment(Government Gazette No. 32685)

REGULATIONS

GNR.352 of 21 February 1975Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council

GNR.906 of 28 May 1993Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council

GNR.510 of 10 April 2003General Regulations

GNR.539 of 25 April 2003Regulations relating to Fees payable to the Registrar

GN 758 of 4 June 2003Application fee: Application for a licence to compound or dispense medicines

GN 759 of 4 June 2003Form: Application for a licence to compound or dispense medicines

GNR.1102 of 11 November 2005Regulations relating to a transparent pricing system for medicines and scheduled substances

GNR.352 of 21 April 2006„Regulasies rakende ’n deursigtige prysstelsel vir medisyne en gelyke stowwe”(Afrikaans only)

GNR.1388 of 24 December 2008Regulations relating to a transparent pricing system for medicines and scheduled substances(Government Gazette No. 31735)

GUIDELINES WITH RESPECT TO THE MEDICINES AND RELATED SUBSTANCES ACT

GNR.609 of 2 May 2003

NOTICES

GNR.509 of 10 April 2003Schedules

GNR.325 of 8 April 2005Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)

GN 326 of 8 April 2005Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)

GN 807 of 5 August 2005Appointment of the Registrar of Medicines

GNR.1212 of 1 December 2006Regulations relating to a transparent pricing system for medicines and scheduled substances: Information to be published by manufacturers and importers of medicines and scheduled substances before taking an increase in the single exit price

GNR.1213 of 1 December 2006Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 01 July 2007

GN 1307 of 22 December 2006Methodology for international benchmarking of the prices of medicines and scheduled

substances in South Africa: Extension of the comments period

GNR.237 of 16 March 2007Regulations relating to a transparent pricing system for medicines and scheduled substances methodology for international benchmarking of the prices of medicines and scheduled substances in South Africa: Extension of the comments period

GN 339 of 27 March 2008Regulations relating to a transparent pricing system for medicines and scheduled substances: Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 31 July 2008(Government Gazette No. 30901)

GN 340 of 27 March 2008Regulations relating to a transparent pricing system for medicines and scheduled substances: Information to be published by manufacturers and importers of medicines and scheduled substances before taking an increase in the single exit price(Government Gazette No. 30901)GN 434 of 11 April 2008Conditions of Registration of a Medicine in Terms of the Provisions of Section 15 (7) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)(Government Gazette No. 30957)

GNR.587 of 30 May 2008Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)(Government Gazette No. 31083)

GNR.588 of 30 May 2008Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)(Government Gazette No. 31083)

GN 613 of 6 June 2008Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965)(Government Gazette No. 31107)

GN 614 of 6 June 2008Exclusion of certain medicines from the operation of certain provisions of the Medicines and Related Substances act, 1965 (Act 101 of 1965)(Government Gazette No. 31107)

GN 905 of 8 August 2008Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7) of the Act(Government Gazette No. 31270)

GN 1244 of 21 November 2008Declaration of medicine as undesirable (section 23 of Act 101 of 1965)


GN 1534 of 19 December 2008Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 31696)

GNR.1389 of 24 December 2008Regulations relating to a transparent pricing system for medicines and scheduled substances: Determination of maximum increase in the single exit price of medicines and scheduled substances for the period up until 30 September 2009(Government Gazette No. 31735)

GN 1269 of 17 October 2008Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 31497)

GN 163 of 20 February 2009Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No.31881)

GNR.713 of 1 July 2009Application fees: Application for a licence to compound or dispense medicines(Government Gazette No. 32358)

GN 1005 of 31 July 2009Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 32440)

GN 821 of 4 August 2009Medicines Control Council: Declaration of medicine as undesirable(Government Gazette No. 32477)

GN 1105 of 14 August 2009Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 32491)

GN 1341 of 9 October 2009Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 32620)

GN 1105 of 9 December 2009Medicines Control Council: Conditions of registration of a medicine in terms of the provisions of section 15 (7)(Government Gazette No. 32774)

TABLE OF REPEALS

The following notices have hereby been repealed:

Repealed Notices As repealed by GNR.553 of 30 April 2004Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances GNR.1102 of 11 November 2005Regulations relating to a transparent pricing system for medicines and scheduled substances

PROPOSED REGULATIONS

GN 2007 of 9 December 2005: Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances(Government Gazette No. 28308)

GN 449 of 31 March 2006: Amends Regulations relating to a transparent pricing system for medicine and scheduled substances(Government Gazette No. 28673)

GNR.623 of 30 June 2006: Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee(Government Gazette No. 28947)

GNR.1211 of 1 December 2006: Methodology for International Benchmarking of the Prices of Medicines and Scheduled Substances in South Africa(Government Gazette No. 29443)

GNR.919 of 2 October 2007: Regulations relating to a transparent pricing system for medicines and scheduled substances(Government Gazette No. 30342)

GN 807 of 29 July 2008: Annual review of the single exit prices of medicines and scheduled substances(Government Gazette No. 31288)

GN 848 of 11 August 2008: Annual review of the single exit prices of medicines and scheduled substances(Government Gazette No. 31327)

GNR.868 of 22 August 2008: General regulations(Government Gazette No. 31334)

GNR.869 of 22 August 2008: Regulations relating to complementary and alternative medicines


GNR.870 of 22 August 2008: Schedules on complementary and alternative medicines in terms of the Act(Government Gazette No. 31334)

GNR.899 of 25 August 2008: Determination of an appropriate logistic fee for medicines and scheduled substances(Government Gazette No. 31357)

GN 1053 of 29 August 2008: Call for comment on a methodology for international benchmarking of originator medicine prices(Government Gazette No. 31369)

GNR.967 of 12 September 2008: Determination of an appropriate logistic fee for medicines and scheduled substances(Government Gazette No. 31404)

GN 1212 of 30 September 2008: Regulations:Transparent pricing system for medicines and scheduled substances: Amendment(Government Gazette No. 31466)

GNR.195 of 23 February 2009Regulations relating to the Transparent Pricing System for Medicines and Scheduled Substances: Amendment(Government Gazette No. 31947)

GNR.688 of 19 June 2009: Regulations: Transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment(Government Gazette No. 32330)

GN 1474 of 6 November 2009: Annual review of the single exit prices of medicines and scheduled substances: Invitation to submit representations(Government Gazette No. 32684)

GNR.1053 of 6 November 2009: Regulations relating to a transparent pricing system for medicines and scheduled substances: Dispensing fee for pharmacists: Amendment(Government Gazette No. 32685)

REGULATIONS

GNR.352 of 21 February 1975: Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council

DEPARTMENT OF HEALTH

GENERAL NOTE

This Regulation is repealed in its entirety by GNR.510 of 10 April 2003, except regulation 35. Subsequently, regulation 35 has been replaced by GNR.539 of 25 April 2003.

GNR.906 of 28 May 1993: Regulations relating to the period and manner of appeal against decisions of the Medicines Control Council

DEPARTMENT OF NATIONAL HEALTH AND POPULATION DEVELOPMENT

The Minister for National Health has, in terms of section 35 (1) and (3) (b) of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), on the recommendation of the Medicines Control Council, made the regulations contained in the Schedule hereto.

SCHEDULE

1. Definition.—In these regulations “the Act” means the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), and any expression to which a meaning has been assigned in the Act shall bear such meaning.

2. Period and manner of appeal.—(a) Appeal in terms of section 24 (1) of the Act against a decision of the Council shall be noted within 42 days after the day on which a notice of such decision is served on the person aggrieved thereby.

(b) Such appeal shall be noted by delivery to the registrar of Medicines, Medicines Control Council, Private Bag X828, Pretoria, 0001, for submission to the Minister, of a notice setting out clearly and succinctly the grounds, whether factual or legal, on which the appeal is based.

GNR.510 of 10 April 2003: General Regulations

as amended by

Notice Government Gazette Date GNR.1506 25593 16 October 2003

as corrected by

Notice Government Gazette Date GN 1565

25622 31 October 2003

MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT No. 101 OF 1965), AS AMENDED

The Minister of Health has, in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), in consultation with the Medicines Control Council, made the regulations in the Schedule.

LIST OF CONTENTS

1. Definitions 2. Requirements for therapeutic equivalence 3. The Manner of and conditions for allowing international tendering 4. The conditions for and the quantity not to be exceeded by a pharmacist in compounding a medicine for sale in the retail trade 5. Expedited registration process for medicines for human use 6. Particulars to be published in the Gazette 7. Importation of medicines in terms of section 15C 8. Labelling of medicines intended for administration to humans 9. Package inserts for medicines for human use 10. Patient information leaflet 11. Prescription book 12. Importation of medicines into the Republic

13. Transmission of medicines through the Republic 14. Permits in terms of section 22A of the Act 15. Importation or exportation of specified Schedule 5, Schedules 6, 7 and 8 substances 16. Possession of specified quantities of scheduled substances for personal medicinal use by persons entering or departing from the Republic 17. Information to be furnished annually to the Director-General by the holder of a permit 18. Licence to dispense or compound and dispense medicines 19. Licence to manufacture, act as a wholesaler or distribute medicines 20. Period of validity of a license issued in terms of regulations 18 and 19 and renewal of licences 21. Appeal against the decision of the Director-General or the Council 22. Application for the registration of a medicine 23. Information that must appear in the register for medicines 24. Application for an amendment to the medicines register 25. Categories and classification of medicines 26. Certificate of registration 27. Destruction of Medicines 28. Particulars which must appear on a prescription or order for a medicine

29. Returns to be furnished in respect of specified Schedule 5, Schedules 6, 7 and a substances 30. Register of specified Schedule 5, Schedules 5 or 6 medicines or substances 31. Method of taking samples during an investigation, the certificate to be issued and the reporting of analysis results 32. Seizure of medicines 33. Repacking of medicines into patient ready packs 34. Conduct of clinical trials for humans 35. Skills of members of the council and its committees 36. Control of medicines in hospitals 37. Adverse drug reaction 38. Pricing committee 39. Investigations 40. Package inserts for veterinary medicines 41. Use of medicines for the prevention of malaria 42. Offences and penalties 43. Compliance with requirements 44. Batch release for biological medicines

45. Advertising of medicines 46. Rules relating to the conduct of business of the Council 47. Obtaining of pethidine or preparations thereof by registered midwives 48. Labelling for veterinary medicine 49. Repeal 50. Commencement

SCHEDULE

1. Definitions.—In these Regulations any word or expression defined in the Act and not defined herein bears the same meaning as in the Act and unless the context otherwise indicates—

“the Act” means the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended;

“adverse drug reaction” means a response in human or animal to a medicine which is harmful and unintended and which occurs at any dosage and can also result from lack of efficacy of a medicine, off-label use of a medicine, overdose, misuse or abuse of a medicine;

“applicant” means a person who submits an application for the registration of a medicine, an update or amendment to an existing registration;

“as determined by council” means as determined by Council in the guidelines as published in the Gazette from time to time;

“authorised prescriber” means any person authorised by the Act to prescribe any medicines;

“batch” or “lot” in relation to a medicine means a defined quantity of a medicine manufactured in a single manufacturing cycle and which has homogeneous properties;

“batch number” or “lot number” means a unique number or combination of numbers or cyphers allocated to a lot or a batch by the manufacturer,

“bioequivalence” means the absence of a significant difference in the bioavailability between two pharmaceutically equivalent products under similar conditions in an appropriately designed study;

“bonded warehouse” means a customs and excise warehouse licenced in terms of section 19 of the Customs and Excise Act, 1964 (Act No. 91 of 1964);

“clinical trial” means an investigation in respect of a medicine for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the medicine, identify any adverse events, study the absorption, distribution, metabolism and excretion of the medicine or ascertain its safety or efficacy;

“counterfeit medicine” means a medicine in respect of which a false representation has been made with regard to its contents, identity or source by any means including its labelling and packaging;“compound” means to prepare, mix, combine, package and label a medicine for dispensing as a result of a prescription for an individual patient by a pharmacist or a person authorised in terms of the Act;

“dispense”—

(a)

in the case of a pharmacist, means dispense as defined in the Regulations Relating to the Practice of Pharmacy made in terms of the Pharmacy Act, 1974; and(b)

in the case of a medical practitioner, dentist, practitioner, nurse or any authorised prescriber to dispense medicines, means—(i)the interpretation and evaluation of a prescription;(ii)the selection, reconstitution, dilution, labelling, recording and supply of the medicine in an appropriate container; or(iii)the provision of information and instructions to ensure safe and effective use of a medicine by a patient;“expiry date” means the date up to which a medicine will retain the strength and other properties which are mentioned on the label which strength and other properties can change after the lapse of time and after which date the medicine shall not be sold to the public or used;

“holder of a certificate of registration” means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medicine, including quality and safety and compliance with conditions of registration;

“manufacture” means all operations including purchasing of material, processing, production, packaging, releasing, storage and shipment of medicines and related substances in accordance with quality assurance and related controls;

“manufacturer” means a person manufacturing a medicine and includes a manufacturing pharmacy;

“minimum legibility” means a printing in 6-point Helvetica, typeface in black ink on white cartridge paper or the equivalent thereof;

“parallel importation” means the importation into the Republic of a medicine protected under patent and/or registered in the Republic that has been put onto the market outside the Republic by or with the consent of such patent holder;

“parallel importer” means a person who parallel imports a medicine into the Republic on the authority of a permit issued in terms of regulation 7 (3);

“person” means both a natural and a juristic person;

“proprietary name”, “brand name” or “trade name” means the name which is unique to a particular medicine and by which the medicine is generally identified and which in the case of a registered medicine is the name approved in terms of section 15 (5) of the Act;

“responsible pharmacist” means a responsible pharmacist as defined in the Pharmacy Act, 1974, (Act No. 53 of 1974);

“Site Master File” means a document prepared by the manufacturer containing specific and factual good manufacturing practice information about the production and/or control of pharmaceutical manufacturing operations carried out at a named site and any closely integrated operations at adjacent and nearby buildings; and

“trademark” means a trademark as defined under section 2 of the Trade Marks Act, 1993 (Act No. 194 of 1993);

“wholesaler” means a dealer who purchases medicines from a manufacturer and sells them to a retailer and includes a wholesale pharmacy.

2. Requirements for therapeutic equivalence.—(1) A medicine is considered therapeutically equivalent to another medicine if both medicines—

(a)

are pharmaceutically equivalent, i.e., contain the same amount of active substances in the same dosage form, meet the same or comparable standards and are intended to be administered by the same route; and(b)

after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same.(2) Therapeutic equivalence is determined from comparative bioavailability, pharmacodynamic, clinical or in vitro studies which meet the requirements and accepted criteria for bioequivalence as determined by the Council.

3. The manner and conditions for allowing international tendering.—(1) The State may tender for a medicine internationally if such a medicine—

(a)

can be obtained at a lower price outside of the Republic; or(b)

is, in the opinion of the Minister, essential for national health.(2) A medicine referred to in subregulation (1), which at the time of request for tenders is not registered, may be subjected to an expedited registration process in terms of regulation 5.

(3) A medicine cannot be procured by international tender unless such medicine is registered in terms of the Act.

4. The conditions for and the quantity not to be exceeded by a pharmacist in compounding a medicine for sale in the retail trade.—A pharmacist compounding a medicine for sale in the retail trade in terms of section 14 (4) (b) of the Act, must only compound a quantity that is—

(a)

related to a treatment regimen of a particular patient; and(b)

to be used by the patient for mot more than 30 consecutive days from the date of dispensing.5. Expedited registration process for medicines for human use.—(1) Expedited registration process for medicines for human use shall be as follows—

(a)

an application for medicines that appear on the Essential Drugs List shall be accompanied by declaration by the applicant that such a medicine appears on such a list; and(b)

for any medicines containing new chemical entities that are considered essential for national health but do not appear on the Essential Drugs List, written notification to that effect from the Minister must be submitted with the application.(2) Applications in respect of medicines referred to in subregulation (1) (b) must be accompanied by a Summary Basis for the Registration Application (SBRA) which contains such information as determined by the Council.

(3) The format of the summary referred to in subregulation (2) and the details to be contained therein shall be as determined by the Council.

(4) The Council may subject certain applications in respect of medicines containing new chemical entities to an abbreviated medicine review process as determined by the Council, where registration has been granted by other medicines regulatory authorities recognised by the Council for the purpose applied for.

(5) The applicant shall be notified by the registrar within 30 days of the date of receipt of the application whether or not the application is to be subjected to expedited registration process.

(6) The Council may request any information with respect to an application under consideration and such information shall be furnished by the applicant within a period

indicated by Council, failing which the Council may reject an application.

(7) The Council shall, within nine months from the date of receipt of the application by the registrar, make a decision with regard to the application and inform the applicant of such decision.

(8) Notwithstanding the above subregulations, an application for an expedited registration process must still comply with regulation 22.

6. Particulars to be published in the Gazette.—The following particulars with regard to applications for registration referred to in section 15 (11) shall be published in the Gazette—

(a)

the proprietary name of the medicine;(b)

the approved name and quantity of each active ingredient of the medicine;(c)

the dosage form of the medicine;(d)

the name of the applicant who lodged the application for registration;(e)

the number allocated to it in terms of section 15 of the Act;( f )

the name and address of the manufacturer and manufacturing facilities; and(g)

the name of the final product release control.7. Importation of medicines in terms of section 15C.—(1) A medicine referred to in section 15C (b) of the Act may be sold if—

(a)

the medicine is being sold outside the Republic with the consent of the holder of the patent of such medicine;(b)

the medicine is imported from a person licenced by a regulatory authority recognised by the council;(c)

the person desiring to import such medicine is in possession of a permit issued by the Minister; and(d)

the medicine is registered in terms of the Act.(2) A person desiring to import a medicine referred to in subregulation (1) must submit to the Minister—

(a)

a duly completed application on a form approved and provided by the Minister;(b)

a certified copy of his or her identity document or in the case of a juristic person, a certificate of registration as such in the Republic;(c)

a certified copy of his, her or its registration in terms of the Pharmacy Act, 1974, where applicable;(d)

a certified copy of a licence in respect of premises in terms of—(i)section 19 of the Customs and Excise Act, 1964 (Act No. 91 of 1964); and(ii)section 22 of the Pharmacy Act, 1974;(e)

documentary proof—(i)that the medicine is under patent in the Republic;(ii)that the medicine is registered in its country of export by a regulatory authority recognised by the council;(iii)regarding the lowest price at which the medicine is sold in the Republic;(iv)regarding the price at which the medicine will be sold in the Republic;(v)that he, she or it is able to comply with good manufacturing and distribution practices as determined by the council; and( f )

an undertaking that he, she or it will ensure the continued safety, efficacy and quality of the medicine.(3) The Minister—

(a)

may approve the application referred to in subregulation (2) with or without conditions;(b)

must if he or she approves the application, issue the applicant with a permit, which is valid for a period of two years;

(c)

may cancel the permit if the holder thereof fails to comply with the conditions of the permit or on any other good cause shown.(4) The permit issued in terms of subregulation (3) may only be transferred with the approval of the Minister.

(5) A person issued with a permit in terms of subregulation (3) must apply to the council for the registration of the medicine specified in the permit by submitting to the Registrar—

(a)

a certified copy of that permit;(b)

a duly completed application form approved and provided by the council; and(c)

an application fee as determined by the council.(6) The council—

(a)

must, if satisfied that the application referred to in subregulation (5) complies with the requirements of the Act and these regulations and those of the council regarding the safety, efficacy and quality of the medicine, and that its registration is in the public interest, approve the application with or without conditions; and(b)

may issue the person referred to in subregulation (5) with a certificate of registration in respect of such medicine under the name approved by the council.(7) The certificate of registration referred to in subregulation (6) may only be transferred with the approval of the council.

(8) A person importing a medicine in terms if this regulation shall in writing inform—

(a)

the Minister of any change of facts in relation to the application for a permit issued in terms of subregulation (5) or conditions under which such permit was issued;(b)

the council of any amendments to the application for the registration of medicines or the conditions for the registration of such medicine;(c)

the holder of a certificate of registration in the Republic of the registration of the medicine in terms of this regulation.(9) A medicine registered in terms of this regulation may only be sold to the State or a person authorised to sell medicines in terms of the Act or any other legislation.

8. Labelling of medicines intended for administration to humans.—(1) Save as provided in subregulations (2), (3) and (4), the immediate container of every medicine in which a medicine intended for administration to humans is sold shall have a label attached to it on which only the following particulars shall appear in clearly legible indelible letters in English and at least one other official language—

(a)

in the case of a medicine listed in any Schedule made in terms of the Act, the letter “S” followed by the number of the relevant Schedule, in a prominent type size and face and surrounded by a square border, immediately preceding the proprietary name of such medicine;(b)

the proprietary name of the medicine;(c)

the registration number of the medicine allocated in terms of section 15 (6) of the Act;(d)

the dosage form of the medicine;(e)

the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit, or per suitable mass or volume or unit, starting with an active ingredient of a high Schedule, in lettering which has minimum legibility;( f )

the name and percentage of any bacteriostatic or bactericidal agent which has been added to the medicine as a preservative;(g)

the approved name of any anti-oxidant contained in the medicine;(h)

in the case of a medicine for oral or parenteral administration, the quantity of—(i)sugar contained in the medicine; or(ii)ethyl alcohol contained in the medicine, expressed as a percentage of the total volume of the medicine, if such quantity exceeds two per cent by volume;(i)

the content of the medicine package expressed in the appropriate unit or volume of the medicine;( j)

approved indications where practical, for use of the medicine;(k)

the recommended dosage of the medicine, where practical;(l)

where applicable, the instruction “Shake the bottle before use”;(m)

in the case of a medicine intended for injection by a particular route of administration only, that route of administration by means of suitable words or abbreviations;(n)

the lot number of the medicine;(o)

the expiry date of the medicine;(p)

the name of the holder of certificate of registration of the said medicine;(q)

the requirements regarding the manner in which the medicine shall be stored with specific reference to the applicable storage temperature and other precautions required for the preservation of the medicine;(r)

where applicable, the statement: “For external use only”;(s)

the warning: “Keep out of reach of children”;(t)

in the case of a medicine which contains aspirin or paracetamol the warning: “Do not use continuously for more than 10 days without consulting your doctor”;(u)

in the case of a medicine for oral administration which contains fluorides, the warning: “Contains fluoride”;(v)

in the case of a medicine for oral administration which contains an antihistamine, the warnings: “This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents”;(w)

in the case of eye drops or artificial tear solutions in respect of which evidence concerning the self-sterilising ability of the medicine has not been approved by the Council, the warning: “Do not use more than 30 days after opening”;(x)

any specified warning required in terms of section 15 (7) to be given on the label of the medicine as a condition of registration thereof;(y)

in the case of a medicine that contains TARTRAZINE, the warning: “Contains TARTRAZINE”.(2) If the medicine package bears both an immediate container label and an outer label, the requirements of subregulation (1) shall apply to the outer label as well: Provided that it shall be sufficient to give on the immediate container label—

(i)in the case of medicines intended for administration by injection and having a total volume not exceeding 5ml, the details prescribed in paragraphs (b), (e), (m), (n), (o) and (p) of subregulation (1);(ii)in the case of an ointment, cream, gel or powder having a net mass not exceeding 10 grams, the details prescribed in paragraphs (b), (c), (e), ( f ), (n), (o), (p) and (x) of subregulation (1);(iii)in the case of liquid, solution or suspension having a total volume of more than 1ml, but not exceeding 15ml, the details prescribed in paragraphs (b), (c), (d), (e), (n), (w), (o), (p) and (x) of subregulation (1);(iv)in the case of a liquid, solution or suspension having a total volume not exceeding 1ml, the details prescribed in paragraphs (b) and (n) of subregulation (1);(v)in the case of a medicine packed in blister or similar packaging, the details prescribed in paragraphs (b), (n), (o) and (p) of subregulation (1), repeated as frequently as is practicable.(3) The Council may authorise the inclusion on the label of a medicine of any special information that is not required by this regulation to be so included.

(4) The requirements of subregulation (1) shall not apply to—

(a)

any medicine sold in accordance with section 14 (4) of the Act;(b)

any medicine sold by a person authorised to dispense in terms of section 22C or a pharmacist in the course of his or her professional activities for the treatment of a particular patient; or(c)

any medicine sold by a pharmacist, a person authorised to compound and dispense, or in a hospital pharmacy in accordance with a prescription issued by a medical practitioner or dentist for the treatment of a particular patient: Provided that such medicine shall be sold in a package to which is attached a label containing the following information—(i)the proprietary name, approved name, or the name of each active ingredient of the medicine, where applicable, or constituent medicine;(ii)the name of the person for whose treatment such medicine is sold;

(iii)the directions in regard to the manner in which such medicine should be used;(iv)the name and business address of the person authorised to sell such a medicine;(v)date of dispensing; and(vi)reference number.9. Package inserts for medicines for human use.—(1) Save as provided in subregulations (2) and (3), each package of a medicine shall be accompanied by a package insert, either as a separate entity or as an integral part of the package, on which are printed in English and at least one other official language and in type having a minimum legibility as defined in regulation 1, under the headings and in the format specified in this regulation, and which shall contain the following particulars—

(a)

scheduling status, i.e the scheduling status of the medicine as determined from time to time by the Minister;(b)

proprietary name and dosage form;(c)

composition, i.e—(i)the approved name of each active ingredient and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine;(ii)the approved name and quantity of any bactericidal or bacteriostatic agent included in the medicine as a preservative, expressed as a percentage;(iii)the quantity of ethyl alcohol included in a preparation for oral or parenteral administration, if such quantity exceeds two per cent by volume;(iv)the words “contains TARTRAZINE” should the medicine contain such ingredient; and(v)in the case of a medicine, for oral administration, which contains or does not contain sugar, the warning: “contains sugar” or “sugar free”, whichever is applicable;(d)

pharmacological classification, i.e. the category, the number and the description of the classification as stated in regulation 25;(e)

pharmacological action, i.e. a description of the pharmacological action of the medicine, and where applicable, under a sub-heading: Pharmacokinetics, pharmacodynamics; summary of clinical studies;( f )

indications;(g)

contra-indications;(h)

warnings;(i)

interactions;( j)

pregnancy and lactation;(k)

dosage and directions for use;(l)

side effects and special precautions;(m)

known symptoms of over dosage and particulars of its treatments;(n)

identification;(o)

presentation;(p)

storage instructions that are practically formulated and which indicate storage temperatures;(q)

registration number, i.e—(i)the number allocated in terms of section 15 (6) of the Act; or(ii)in the case of a medicine the registration of which has been applied for, the reference number allocated to such application, followed by the expression “Act 101/1965”;(r)

name and business address of the holder of the certificate of registration, or in case of a parallel imported medicine, the name and business address of the holder of the parallel importer permit;(s)

date of publication of the package insert: Provided that—(i)if the Council decides that there is no applicable information to be furnished under a particular heading, such heading may be omitted with the approval of Council;

(ii)the Council may on application authorise the deviation from the format and content of a package insert prescribed as a condition of registration of a medicine;(iii)the Council may on application authorise the inclusion on a package insert of any specified information not required by this regulation to be so included; and(iv)the Council may on application determine under a particular heading the information to be furnished in respect of an interchangeable multisource medicine.(2) The requirements of subregulation (1) shall not apply in the case of medicines in respect of which exclusion from the operation the Act has been granted by the Minister in terms of section 36 of the Act.

(3) The requirements of subregulation (1) shall not apply to—

(a)

any medicine sold in accordance with the provisions of section 14 (4);(b)

any medicine compounded and/or sold by a medical practitioner, dentist, pharmacist or any other person who is authorised to dispense medicines in the course of his or her professional activities for the treatment of a particular patient;(c)

any medicine sold by a pharmacist or by a hospital pharmacy in accordance with a prescription issued by a medical practitioner or dentist for the treatment of a particular patient.(4) Nothing contained in subregulation (2) and (3) shall be construed as prohibiting the inclusion of a package insert in the medicine.

(5) The council may withdraw any indication if it is of the opinion that the risk and benefit profile of the medicine for the approved indications for which they have been registered is not in the public interest.

10. Patient information leaflet.—(1) Each package of a medicine shall have a patient information leaflet that must contain the following information with regard to the medicine in at least English and one other official language—

(a)

scheduling status;(b)

proprietary name and dosage form;(c)

the composition of the medicine i.e information contemplated in regulation 9 (1) (c);(d)

the approved indications and use;(e)

instructions before taking the medicine, which include—(i)contra-indications;(ii)precautions;(iii)warnings e.g. concerning sedative properties of the medicine or risks involved with sudden withdrawal of the medicine;(iv)interactions;(v)the following general statements:“If you are taking medicines on a regular basis, using the medicine at the same time with another medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice.”

“If you are pregnant or breast feeding your baby while taking this medicine please consult your doctor, pharmacist or other health care professional for advice.”;

( f )

instructions on how to take the medicine, including the following statements:“Do not share medicines prescribed for you with any other person.”

“In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.”;

(g)

side effects, including the following general statement:“Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.”;

(h)

storage and disposal information, including the following general statement: “Store all medicines out of reach of children.”;(i)

presentation, which includes the number, volume or mass per package unit and a description of the packaging material, e.g. bottle, blister pack, etc.;( j)

identification of the medicine, i.e. the description of its physical appearance as tablet, capsule, etc.;(k)

registration number of the medicine;(l)

the name, business address and telephone number of the holder of the certificate of registration; and(m)

the date of publication of the patient information leaflet.(2) The Council may authorise a deviation from subregulation (1).

(3) A person dispensing or administering a medicine must ensure that a patient information leaflet is made available at the point of such dispensing or administration.

(4) The Council may, on application, in respect of an interchangeable multisource medicine determine additional information to be furnished under a particular heading.

11. Prescription book.—(1) A prescription book or other permanent record in respect of Schedule 2, 3, 4, 5 and 6 medicines or substances shall be kept on all premises where prescribed medicines are dispensed or sold and shall contain the following details—

(a)

the name of the medicine or scheduled substance;(b)

the date on which the prescription was dispensed;(c)

the dosage form and quantity of the medicine or scheduled substance;(d)

the name and address of the patient, or, in the case of a prescription issued by a veterinarian, the name and address of the person to whom the medicine or scheduled substance was sold;(e)

where applicable the name of the medical practitioner, dentist, veterinarian or any other authorised person who issued the prescription; and( f )

prescription reference number.(2) In the case of Schedule 1 medicine sold without a prescription in terms of section 22A (4) of the Act, the following shall be recorded—

(a)

the name of the person to whom it was sold;(b)

its name and quantity; and

(c)the name of the pharmacist or intern pharmacist or pharmacist assistant who sold it.(3) A prescription record shall be retained at the business address of the seller for a period of at least five years after the date of the last entry made therein.

(4) The manufacturer or wholesaler shall keep a record of Schedule 2, 3, 4 and 5 medicines and substances in the form of invoices that will reflect—

(a)

the date and transaction of every sale;(b)

the name of the medicine;(c)

the name and address of every purchaser;(d)

the quantities sold;(e)

the batch number; and( f )

the price at which the medicine was sold.(5) A record referred to in subregulation (4) shall be kept for a period of five years from the date of sale.

12. Importation of medicines into the Republic.—(1) No person shall import any medicine or scheduled substance, including medicines imported in terms of section 15C of the Act, read together with regulation 7, into the Republic except through one of the following ports of entry—

(a)

Cape Town Airport or harbour;(b)

Port Elizabeth Airport or harbour;(c)

Durban Airport or harbour; and(d)

Johannesburg international airport.(2) A person can only import a medicine or scheduled substance if such person—

(a)

is licensed in terms of the Act to import medicines; and(b)

in the case of unregistered medicines, is authorised by the Council to import such unregistered medicines.13. Transmission of medicines through the Republic.—(1) Medicines, scheduled substances and mixtures containing scheduled substances that are transmitted through the Republic shall—

(a)

while in the Republic be stored in a bonded warehouse which is registered with the Council; and(b)

not be manipulated while in the bonded warehouse unless authorised by the Council.(2) A bonded warehouse referred to in subregulation (1) must comply with good storage conditions as determined by the Council.

14. Permits in terms of section 22A of the Act.—(1) A medical practitioner or veterinarian desiring to be provided with a Schedule 8 substance for the treatment or prevention of a medical condition in a particular patient, shall apply to the Director-General for a permit to use such substance.

(2) An application referred to in subregulation (1) shall contain at least the following information—

(a)

name and address (both physical and postal) of applicant;(b)

identification number of the applicant;(c)

registration number of the applicant with statutory council;(d)

qualifications of the applicant;(e)

telephone and facsimile numbers of applicant;( f )

purpose for which the application is made;(g)

in the case of a medical practitioner, the name and address of the patient, diagnosis, dosage and period of treatment; and(h)

in the case of a veterinarian, the name and address of the owner of the animal, diagnosis, dosage and period of treatment.(3) A permit referred to in subregulation (1) may not be issued if the Director-General is of the opinion that the applicant is not capable of keeping or storing the substance in a manner so as to prevent the loss thereof.

(4) An analyst or researcher, desiring to be provided with a Schedule 6 or Schedule 7 substance for the purpose of education, analysis or research, shall apply to the Director-General for a permit to use such substance.


(a)


identification number of applicant;(c)

name and address of employer,(d)

qualifications of the applicant;(e)

telephone and facsimile numbers of applicant;( f )

particulars of the research project;(g)

address at which research will be undertaken;(h)

estimated duration of project;(i)

total quantity of scheduled substances to be kept in stock per annum;( j)

source of supply; and(k)

the place where and the manner in which the scheduled substances shall be stored safely.(6) The Director-General may grant or refuse an application referred to in subregulation (4).(7) Any person desiring to manufacture a Schedule 6 substance, shall apply to the Director-General for a permit to manufacture such substance.


(a)

name and address (both physical and postal) of the applicant;(b)

registration number of applicant with the South African Pharmacy Council;(c)

a certified copy of a manufacturing licence issued by the Council;(d)

telephone and facsimile numbers of applicant;(e)

address at which manufacturing is to be undertaken; and( f )

estimated quantity of Schedule 6 substance that will be manufactured.(9) Any person desiring to manufacture, use or supply a Schedule 5 or Schedule 6 substance for other than medicinal purposes, shall apply to the Director-General for a permit to manufacture such substance.


(a)


identification number of the applicant;(c)

registration number of the applicant with a statutory council;(d)

qualification of the applicant;(e)

telephone and facsimile numbers of applicant; and( f )

purpose for which the application is made.(11) A medical practitioner or veterinarian shall not be authorised to administer a scheduled substance or medicine for other than medicinal purposes for administration outside any hospital for the satisfaction or relief of a habit or craving unless he or she complies with the

conditions as determined by the Director-General.

(12) The Director-General may issue a permit referred to in subregulation (9) only after consultation with the Drug Advisory Board and the Council.

(13) The medical practitioner or veterinarian referred to in this regulation is subject to regular inspections in terms of the Act.

(14) The permit may be withdrawn, revoked or suspended by the Director-General if the person issued with such a permit fails to comply with the conditions or requirements for issuing the permit.

15. Importation or exportation of specified Schedule 5, Schedules 6, 7 and 8 substances.—(1) Any person desiring to import or export specified Schedule 5, Schedules 6, 7 or 8 substances shall apply to the Director-General for a permit to import or export such substances.

(2) An application referred to in subregulation (1) shall contain at least information referred to in regulation 14 (2).

(3) The applicant must submit with the application a certified copy of the permit for importation issued by the country to which the substance is to be exported.

(4) A permit issued in terms of subregulation (1) shall be valid for a period of six months.

16. Possession of specified quantities of scheduled substances for personal medicinal use by persons entering or departing from the Republic.—(1) Notwithstanding regulation 12 and subject to subregulation (3) any person entering or departing from the Republic may be in possession, for personal medicinal use, of a quantity of a Schedule, 3, 4, 5 or 6 substance, which shall not exceed a quantity required for use for a period of one month.

(2) A person referred to in subregulation (1) must have—

(a)

a valid prescription for such scheduled substance or medicine; or(b)

a certificate by an authorised prescriber or a person dispensing such scheduled substance or medicine to the effect that the scheduled substance or medicine concerned including its quantity was prescribed for the person including the name and address of such authorised prescriber; and(c)

his or her particulars of residence in the Republic, in the case of the person entering the Republic, recorded at the port of entry.17. Information to be furnished annually to the director-general by the holder of a permit.—(1) A person issued with a permit in terms of regulation 15 shall furnish the Director-General with the following information with regard to the substances referred to in that regulation—

(a)

the quantity of the substance, as a raw material or as contained in a preparation, which was held in stock on 1 January of the preceding calendar year;(b)

the quantity of such substance acquired during the preceding calendar year by(i)importation of the substance, as a raw material or as contained in a preparation;(ii)local production of the raw material;(iii)local purchasing of the raw material, in which case the name of the supplier shall also be furnished;(c)

the quantity of such substance, as a raw material or as contained in a preparation, which was disposed of during the preceding year through exportation or other means;(d)

the quantity of such substance used during the preceding calendar year in the production of any other Schedule 6 or Schedule 7 substance or a specified substance referred to in section 22A (12) (a) (ii) and (iii) of the Act;(e)

the quantity of such substances and preparations containing such substances remaining in stock on 31 December of the preceding year.(2) The information referred to in subregulation (1) shall comply with the following requirements—

(a)

quantities shall be expressed in metric units or as a percentage of the relevant substance;(b)

in the case of opium and any preparations containing opium, quantities shall be expressed in terms of opium containing 10 per cent of anhydrous morphine;(c)

preparations not obtained directly from opium but from a mixture of opium alkaloids shall be expressed in terms of morphine;(d)

quantities of coca-leaves shall be expressed in terms of coca-leaves containing 0,5 percent of cocaine; and(e)

where stocks are held or manufacture has been undertaken on behalf of another person, this fact shall be indicated.18. Licence to dispense or compound and dispense medicines.—(1) As contemplated in

section 22C (1) of the Act, a medical practitioner, dentist or any other person registered in terms of the Health Professions Act, 1974 (Act No. 56 of 1974), practitioner or nurse desiring to dispense or compound and dispense medicines shall apply to the Director-General for a licence to dispense or compound and dispense medicines.

(2) An application referred to in subregulation (1) shall be accompanied by an application fee as determined by the Director-General.

(3) The application shall contain at least the following information—

(a)

the name and both residential and business addresses (both physical and postal) of the applicant;(b)

the exact location of the premises where compounding and/or dispensing will be carried out;(c)

. . . . . .[Para. (c) deleted by GNR.1506 of 2003 (English only).]

(d)

telephone and fax numbers of the applicant, where available;(e)

proof of registration with the relevant statutory council;( f )

proof of publication of the notice contemplated in subregulation (5);(g)

motivation, as to the need for a licence in a particular area;(h)

any other information that the Director-General may require; and(i)

proof of ability to supply a patient information leaflet.(4) The application referred to in subregulation (1) may be submitted even before a supplementary course as contemplated in section 22C of the Act is completed, but a licence may only be issued upon proof being furnished that such a course has been successfully completed and all other requirements have been met.[Sub-r. (4) inserted by GNR.1506 of 2003 (English only).]

(5) In considering an application referred to in subregulation (1), the Director-General shall have regard to the following—

(a)

the existence of other licensed health facilities in the vicinity of the premises from where the compounding and dispensing of medicines is intended to be carried out;(b)

representations, if any, by other interested persons as to whether a licence should be granted or not;(c)

the geographic area to be served by the applicant;(d)

the estimated number of health care users in the geographic area referred to in paragraph (c);(e)

demographic considerations including disease patterns and health status of the users to be served; and( f )

any other information that he or she deems necessary.[Sub-r. (5), previously sub-r. (4), renumbered by GNR.1506 of 2003 (English only).]

(6) At the same time when an application referred to in subregulation (1) is made, the applicant must also give notice by publication in a newspaper circulating in the area where the applicant intends to conduct his or her practice of his or her intention to apply for a licence.

[Sub-r. (6), previously sub-r. (5), renumbered by GNR.1506 of 2003 (English only).]

(7) Any person may support or oppose an application referred to in subregulation (1) by making written representations to the Director-General within 30 days of publication of the notice contemplated in subregulation (5).


(8) A person referred to in subregulation (1) who has been issued with a licence shall—

(a)

keep sales records either in hard copy or electronically relating to medicines compounded and dispensed for a period of 5 years from the date of sale;(b)

ensure that the dispensary and any premises where medicines are kept are suitable for dispensing or compounding and dispensing in accordance with good pharmacy practice;(c)

keep the medicines under the manufacturer’s recommended storage conditions as specified on the medicines label and or package insert;(d)

not pre-pack medicines at the premises unless authorised to do so by the Director-General and in terms of regulation 33 (a) (ii);(e)

label medicines properly with the name of the patient and a reference number linking the patient to a patient record;( f )

not compound and dispense medicines to patients unless the sale is preceded by a proper diagnosis and a prescription for a particular patient;(g)

not keep expired medicines on the premises other than in a demarcated area in a sealed container clearly marked: EXPIRED MEDICINES and such expired medicines shall be destroyed in terms of regulation 27;(h)

secure the premises where the compounding and dispensing is carried out whenever he or she is not physically present at those premises;(i)

in the event of a recall of a medicine, withdraw the medicine;( j)

conspicuously display the licence in the premises referred to in paragraph (b); and(k)

comply with the conditions of his or her licence.[Sub-r. (8), previously sub-r. (7), renumbered by GNR.1506 of 2003 (English only).]

(9) For the purposes of this regulation, “compounding and dispensing” does not refer to a medicine requiring preparation for a once-off administration to a patient during a consultation.


19. Licence to manufacture, act as a wholesaler or distribute medicines.—(1) A person referred to in section 22C (1) (b) of the Act—

(a)

must prior to commencing business as such—(i)apply to the Council for a licence to manufacture, import or export, act as wholesaler or distribute medicines, scheduled substances or medical devices;(ii)appoint, and designate as such a pharmacist who will control the manufacturing or distribution of medicines, scheduled substances or medical devices;(iii)

appoint and designate a natural person who resides in the Republic, who shall be responsible to Council for compliance with the Act;(b)

must submit to the registrar an application, on a form approved and provided by the Council, for a licence as contemplated in subregulation (1) (a) (i);(c)

must as part of the application in subregulation (1) (b) provide acceptable documentary proof of—(i)the particulars of the owner of the business;(ii)registration of the responsible pharmacist;(iii)qualifications of staff to manufacture, store, distribute and sell medicines, scheduled substances or medical devices in terms of the Act;(iv)the ability to comply with good manufacturing or distribution practices as determined by Council, which must include—(aa)

a copy of a local area plan of the location of the business premises indicating all adjacent properties and the nature of the business being carried on, on such properties;(bb)

a floor plan of the building in which the business premises are situated;(cc)

a plan of the actual layout of the business premises;(dd)

an inventory of equipment to be used in conducting the business;(ee)

a manual of procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines, or scheduled substances or medical devices to be manufactured or distributed and sold;(d)

must specify the medicines, scheduled substance or medical devices to be manufactured or distributed and sold;(e)must pay the application and inspection fees as determined by the Council.(2) The registrar may give the person referred to in subregulation (1) written notice to furnish the Council with such additional documentation or information as the Council may require, within a reasonable time, specified in the notice.

(3) The Council must inspect the business premises specified in the application.

(4) If the Council is satisfied that—

(a)

the person referred to in subregulation (1) complies with the prescribed requirements;(b)

the application for a licence to manufacture, act as wholesaler, or distribute medicines, scheduled substances, or medical devices complies with the prescribed requirements;(c)

the applicant is able to comply with good manufacturing or distribution practices,then the Council must approve, with or without conditions, the application and issue such person with a licence.

(5) The registrar must—

(a)

keep a separate register for each of the categories of licensees referred to in subregulation (1) (a) (i) ; and(b)

enter the licence number, the name of the licensee and his or her physical and postal addresses, in such register.(6) Notwithstanding the period of validity of the licence the licensee shall pay the annual fee for continued registration as determined by the Council.

(7) A licensee must notify the registrar in writing of any change to any of the particulars furnished in the application or entered in the register, which occurs after the issue of the licence.

(8) Any entry into the register which is proved to the satisfaction of the Council to have been made in error or through misrepresentation or in circumstances not authorised by the Act, may be removed from the register.

(9) A person in respect of whose entry a removal as contemplated in subregulation (8) has been made, must be notified of such removal and any certificate issued in respect of the registration in question shall be deemed to be cancelled as from the date on which notice has so been given.

(10) The Council may direct the registrar to remove from the register the name of the licensee—

(a)

who does not comply with the Act or the conditions of a licence;(b)

if the responsible pharmacist fails to control the manufacturing or distribution of medicines,

scheduled substances, or medical devices;and the licensee has failed to furnish written reasons within 21 days after the date upon which a notice is given of the Council’s intention to remove the name of the licensee from the relevant register and to close such business why the licensee’s name should not be removed or the business should not be closed: Provided that if the Council is of the opinion that it is in the interest of the public, it may dispense with the required notice.

20. Period of validity of a license issued in terms of regulations 18 and 19 and renewal of licences.—(1) A licence issued in terms of regulation 18 shall be valid for a period of 3 years whereas a licence issued in terms of regulation 19 shall be valid for a period of 5 years from the date of issue.

(2) A licence referred to in subregulation (1) which has expired may be renewed upon application to the Director-General or the Council, as the case may be.

(3) An application referred to in subregulation (2) shall—

(a)

contain at least the information or documentation referred to in regulations 18 (3) and 19 (1) (c), as the case may be;(b)

be accompanied by a prescribed fee; and(c)

be made at least 90 days before the expiry of the existing licence.21. Appeal against the decision of the Director-General or the Council.—(1) An appeal to be lodged or representations to be made in terms of section 24 of the Act shall be lodged or made within 30 days from the date on which the decision appealed against or in respect of which representations are made was communicated to the appellant or person making representations.

(2) In lodging the appeal or making representations, the appellant or person making representations shall send a notice by registered mail to the Minister or the Director-General, whatever the case may be, and—

(a)

in the case of a decision of the Council, to the Registrar of Medicines, Medicines Control Council, Private Bag X828, Pretoria, 0001, or(b)

in the case of a decision of the Director-General, to the Director- General, Department of Health, Private Bag X828, Pretoria, 0001, stating the decision in respect of which representations are made.(3) The notice referred to in subregulation (2) shall set out clearly and succinctly the basis for the appeal or representations.

(4) The Minister shall within 30 days of receipt of notice of appeal, appoint an appeal

committee to decide the appeal.

(5) The Director-General shall within 15 days of receipt of the notice referred to in subregulation (2), submit such notice to the Minister and the Minister shall make a decision on the decision of the Director-General within 30 days from the date on which—

(a)

the notice was received; or(b)

the consideration of the representations was completed; whichever is the later.(6) The appeal committee—

(a)

shall determine the procedure for its hearings;(b)

may, if it deems necessary call for oral evidence or argument or summon any person who—(i)in its opinion may be able to give information concerning the subject of the appeal; or(ii)it believes has in his or her possession or under control any document which has a bearing on the subject of the appeal, to appear before it at a time and place specified in the summons, to be asked questions or to produce any document; and(c)

shall, if it calls for oral evidence or argument—(i)determine the date, time and place for the appeal and shall communicate these in writing to the appellant and the Council;(ii)administer an oath to or accept an affirmation from any person called as a witness at the appeal.(7) Persons appearing before the Appeal Committee may be represented by a legal practitioner.

(8) The Appeal Committee shall consider the appeal and make a decision in regard thereto within a period of 30 days from the date—(a)

on which it was appointed; or,(b)

when the appeal hearing was completed,whichever is the later.

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