Republic Act No. 9711 the Food and Drug Administration Act of 2009 Implementing Rules and...

5/25/2018 Republic Act No. 9711 the Food and Drug Administration Act of 2009 Implementing Rules and Regulations Nylydal 03-31-14

1/75

- i -

The Rules and RegulationsImplementing Republic Act No. 9711

The Food and Drug Administration Act of 2009

TABLE OF CONTENTSPage No.

BBOOOOKKII

ARTICLE IPRELIMINARY PROVISIONS

Sec. 1 Title 1Sec. 2 Declaration of Policy 1Sec. 3 Objectives 1-2Sec. 4 Interpretation of the FDA Implementing Rules and

Regulations

2

Sec. 5 Definition of Terms 2-9

ARTICLE II

A. THE FOOD AND DRUG ADMINISTRATIONSec. 1 Nature 9Sec. 2 General Powers and Functions 9-13

B. RETENTION AND USE OF THE FDA INCOME

Sec. 3 Authority of the FDA to Retain and Utilize its Income 13Sec. 4 Special Regulatory Fund 13Sec. 5 Grants, Donations and All Other Endowments to the SRF 13Sec. 6 SRF Depository 13-14Sec. 7 Use and Accounting of the SRF 14Sec. 8 Legal Fund 14-15Sec. 9 Reporting Requirement 15

C. COMMON PROVISIONS CONCERNINGQUALIFICATIONS, DISQUALIFICATIONS,PRE-REQUISITES, APPOINTMENT OF FDA OFFICERS,PERSONNEL, STAFF AND EMPLOYEES

Sec. 10 Appointment of, and Disciplinary Action Against, AllPersonnel

15

Sec. 11 Authority to Appoint the Director-General and DeputyDirector-Generals

15

Sec. 12 Authority to Appoint Officials in Director and Assistant-Director Levels

15

Sec. 13 Authority to Appoint Officials and Other Personnel andEmployees Below the Assistant-Director Level

15


2/75

- ii -

Sec. 14 Inhibitions Against Officials and Employees of the FDA 15-16Sec. 15 Director-General and Deputy Director-Generals:

Prohibition Against Management and SupervisoryPersonnel Formerly Employed inRegulated Establishments

16

Sec. 16 Director-General and Deputy Director-Generals:

Declaration of any Conflict of Interest

16

Sec. 17 Publication of Vacancies 16

ARTICLE IIIOFFICE OF THE DIRECTOR-GENERAL

Sec. 1 Qualifications of the Director-General 16-17Sec. 2 Duties and Functions of the Director-General 17-20Sec. 3 Offices Under the Director-General 20

ARTICLE IVOFFICE OF THE DEPUTY DIRECTOR-GENERAL

FOR ADMINISTRATION AND FINANCE

Sec. 1 Qualifications of the Deputy Director-General forAdministration and Finance

20

Sec. 2 Powers and Functions of the Deputy Director-General forAdministration and Finance

21

Sec. 3 Offices under the Deputy Director-General forAdministration and Finance

21

Sec. 4 Powers and Functions of the Offices under the DeputyDirector General for Administration and Finance

21-23

ARTICLE V

POLICY AND PLANNING OFFICE

Sec. 1 Policy and Planning Office 24Sec. 2 Powers and Functions of the Policy and Planning Office 24-25Sec. 3 Offices under the PPO 25

ARTICLE VILEGAL SERVICES SUPPORT CENTER

Sec. 1 Legal Services Support Center 25Sec. 2 Qualifications of the Director for Legal Services

Support Center

25

Sec. 3 Powers and Functions of the Legal Services Support Center 25-26Sec. (3) 4 Offices under the LSSC 26


3/75

- iii -

ARTICLE VIITHE CENTERS

A. COMMON PROVISIONS FOR THE CENTERS

POWER AND FUNCTIONS OF THE CENTERS

Sec. 1 The Four Centers 27Sec. 2 Powers and Functions of the Centers 27-29

DIVISIONS OF EACH CENTERSSec. 3 Division Composition of the Centers 29

[I]. LICENSING AND REGISTRATION DIVISIONSec. 4 Powers and Functions of the Licensing

and Registration Division29

[II] PRODUCT RESEARCH AND STANDARDSDEVELOPMENT DIVISION

Sec. 5 Powers and Functions of the Product Research andStandards Development Division

30-31

[III] LABORATORY SUPPORT DIVISIONSec. 6 Powers and Functions of the Laboratory Support Division 31-32Sec. 7 Other Government and Private Testing Laboratories 32

[IV] RISK MANAGEMENT ANDSURVEILLANCE DIVISION

Sec. 8 Powers and Functions of the Risk Management andSurveillance Division

32-33

B. CENTER FOR DRUG REGULATIONAND RESEARCH

Sec. 9 Product Jurisdiction 33

C. CENTER FOR FOOD REGULATION AND RESEARCHSec. 10 Product Jurisdiction 33

D. CENTER FOR COSMETICS REGULATION ANDRESEARCH

Sec. 11 Product Jurisdiction 34

E. CENTER FOR DEVICE REGULATION, RADIATIONHEALTH, AND RESEARCH

Sec. 12 Product Jurisdiction 34Sec. 13 The Radiation Regulation Division 34-35


4/75

- iv -

ARTICLE VIIIFIELD REGULATORY OPERATIONS OFFICE

A. OFFICE OF THE DEPUTY DIRECTOR-GENERALFOR FIELD REGULATORY OPERATIONS

Sec. 1 Qualifications of the Deputy Director-General for FieldRegulatory Operations

35-36

Sec. 2 Duties and Functions of the Deputy Director-General forField Regulatory Operations Office

36

Sec. 3 Offices under the Deputy Director-General for FieldRegulatory Operations

36

B. REGIONAL FIELD OFFICES

OFFICE OF THE DIRECTORAND ASSISTANT DIRECTOR

Sec. 4 Establishment of Regional Field Office 37Sec. 5 Powers and Functions of the Regional Field Offices 37-38

DIVISIONS

Sec. 6 Divisions under the Regional Field Offices 38

[I] LICENSING, INSPECTION, ANDCOMPLIANCE DIVISION

Sec. 7 Powers and Functions of the Licensing, Inspection, andCompliance Division

38-39

[II] SATELLITE LABORATORY DIVISIONSec. 8 Establishments of Satellite Laboratories 39Sec. 9 Powers and Functions of the Satellite Laboratory Division 39-40

[III] ADMINISTRATIVE DIVISIONSec. 10 Powers and Functions of the Administrative Division 40

C. TESTING AND QUALITY ASSURANCELABORATORIES

Sec. 11 Testing and Quality Assurance Laboratories 40-41

D. REGULATORY ENFORCEMENT UNITS (REUs)

Sec. 12 Regulatory Enforcement Units Personnel Composition 41Sec. 13 Qualifications of the Head and Assistant Head of REUs 41Sec. 14 Duties and Functions of the Personnel

Assigned in the REUs41-42

Sec. 15 Necessary Training 42Sec. 16 Administrative Support to the REUs 42Sec. 17 Term for Establishment of the REUs 42


5/75

- v -

BOOK II

ARTICLE ILICENSING OF ESTABLISHMENTS ANDREGISTRATION OF HEALTH PRODUCTS

Sec. 1 General Provisions. 43Sec. 2 Rules and Regulations on Licensing of Establishments and

Registration of Health Products43

Sec. 3 Approval of License of Establishments and Registration ofHealth Products

43

A. License to Operate 43-44B. Authorization/Certificate of Product Registration 44-45

Sec. 4 Grounds for Disapproval of Application and Suspension orCancellation of License or Registration

45

A. License to Operate 45B. Authorization/Certificate of Product Registration 45-46

Sec. 5 Petition for Denial of Application for Registration orSuspension, Revocation or Cancellation of ExistingRegistration

46-47

Sec. 6 Other Rules 47

ARTICLE IILABELING OF HEALTH PRODUCTS

Sec. 1 General Provision 47Sec. 2 Rules and Regulations on Labeling 47Sec. 3 Exception to the Requirements of Labeling 47

ARTICLE IIITOBACCO REGULATION AND CONTROL 47

Sec. 1 Rationale 48Sec. 2 Applicability 48Sec. 3 Rules and Other Issuances to Implement this Article 48

ARTICLE IVLABORATORY ACCREDITATION

Sec. 1 Accreditation of Private Testing Laboratories 48Sec. 2 Application Requirements and Procedure for Accreditation 48

Sec. 3 Grant of Accreditation 49Sec. 4 Grounds for Disapproval of Application, Cancellation or

Suspension of Accreditation49-50

Sec. 5 Accreditation Fees 50


6/75

- vi -

ARTICLE VADVERTISEMENTS, PROMOTIONS, SPONSORSHIP,

AND OTHER MARKETING ACTIVITIES

Sec. 1 General Provision 50

Sec. 2 General Rules on Advertisements, Promotions,Sponsorship, and Other Marketing Activities ofany Health Product

51

Sec. (4) 3 Responsibilities of Manufacturer, Owner, Distributor,Advertiser and/or Their Agents

51

BOOK IIIUNIFORM RULES OF PROCEDURES

ARTICLE I

GENERAL PROVISIONS

Sec. 1 Title 52Sec. 2 Applicability 52Sec. 3 Interpretation 52Sec. 4 Rules of Evidence 52Sec. 5 Suppletory Application of the Rules of Court and of the

Administrative Code52

ARTICLE IIVENUE OF ACTIONS

Sec. 1 Venue of Actions 52

ARTICLE IIIPARTIES

Sec. 1 Who may be parties 53Sec. 2 Actions against entity without juridical personality 53

ARTICLE IVCOMMENCEMENT OF ACTIONS

Sec. 1 Action; How Commenced 53

Sec. 2 Fees and Other Charges 53Sec. 3 Complaint or Petition by a Party 53-54Sec. 4 Actions initiated by FDA 54Sec. 5 Cases Referred by the Consumer Arbitration Officer or

Government Office or Officer54

Sec. 6 Anonymous Complaints/Petitions; Requests forConfidentiality

54

ARTICLE V


7/75

- vii -

SERVICE OF PLEADINGS AND OTHER PAPERS

Sec. 1 Filing and Service of Pleadings 55Sec. 2 Service of Summons, Notices, Decisions and Orders 55

ARTICLE VIPLEADINGS OR MOTIONS

Sec. 1 Prohibited Pleadings or Motions 55

ARTICLE VIIPROCEEDINGS BEFORE THE FDA

Sec. 1 Docketing of Cases 56Sec. 2 Summons 56Sec. 3 Temporary and/or Preventive Measure Order 56-57

ARTICLE VIIIPRELIMINARY CONFERENCE

Sec. 1 Preliminary Conference/Clarificatory Hearing 57

ARTICLE IXSUBPOENA

Sec. 1 Subpoena duces tecum and ad testificandum 57

ARTICLE XPOSITION PAPER

Sec. 1 Submission of Position Paper and Supporting Evidence 58

ARTICLE XIDECISION AND ADMINISTRATIVE

PENALTIES/SANCTIONS

Sec. 1 When case submitted for decision 58Sec. 2 Findings and Recommendation of the Regional

Field Director58

Sec.3 Review and Recommendations of the Deputy DirectorGeneral for Field Operations

58

Sec. 4 Decision of the Director-General 59

Sec. 5 Imposition of Administrative Penalties 59-60Sec. 6 Voluntary Compliance by the Respondent 60

ARTICLE XIIFINALITY OF DECISIONS/APPEAL

Sec. 1 Finality of Decision 60Sec. 2 Motion for Reconsideration or Appeal 60Sec. 3 Motion for Reconsideration 60-61


8/75

- viii -

Sec. 4 Appeal 61Sec. 5 Appeal does not stay execution 61

ARTICLE XIIIEXECUTION OF DECISIONS

Sec. 1 Execution 61

ARTICLE XIVOTHER PROVISIONS

Sec. 1 Treatment of Pending Cases 61

BOOK IV

ARTICLE I

TRANSITORY PROVISIONS

Sec. 1 Continuation of Appointments 62Sec. 2 No Demotion in Ranks and Positions and No Diminution

in Salaries, Benefits, Allowances and Emoluments62

Sec. 3 Transfer of Positions and Functions; Transfer of Facilities,Equipment, etc

62-66

Sec. 4 Establishment of the Regulatory Enforcement Units 66Sec. 5 Existing Rules and Regulations on the BFAD 66Sec. 6 Human Resource Development and Expansion 66

ARTICLE II

SEPARABILITY AND EFFECTIVITY CLAUSES

Sec. 1 Separabillity Clause 67Sec. 2 Effectivity Clause 67


9/75

1

FDA-Implementing Rules and Regulations

As of 19 July 2010

The Rules and RegulationsImplementing Republic Act No. 9711

The Food and Drug Administration Act of 2009

BBOOOOKKII

ARTICLE I

PRELIMINARY PROVISIONS

Sec. 1. Title. These Rules and Regulations shall be referred to as TheRules and Regulations Implementing Republic Act No. 9711 or The Food and Drug

Administration (FDA) Act of 2009.

Sec. 2. Declaration of Policy. These Rules and Regulations arepromulgated to adopt, support, establish, institutionalize, improve andmaintain structures, processes, mechanisms, measures and initiatives that areaimed, directed and designed to:

(a) Protect and promote the right to health of the Filipino people;and

(b) Help establish and maintain an effective health productsregulatory system and undertake appropriate health manpower developmentand research, responsive to the countrys health needs and problems.

Accordingly, the State shall enhance FDAs regulatory capacity andstrengthen its capability with regard to the inspection, licensing andmonitoring of establishments and the registration and monitoring of health

products. (Sec. 3, RA 9711)

Sec. 3. Objectives. These Rules and Regulations are likewisepromulgated to be consistent with the following express objectives of the FDAAct of 2009:


10/75

2

(a) To enhance and strengthen the administrative and technicalcapacity of the FDA in the regulation of establishments and products underits jurisdiction;

(b) To ensure the FDAs monitoring and regulatory coverage overestablishments and products under its jurisdiction; and

(c) To provide coherence in the FDAs regulatory system forestablishments and products under its jurisdiction. (Sec. 4, RA 9711)

Sec. 4. Interpretation of the FDA Implementing Rules andRegulations. Any doubt in the interpretation of these Rules and Regulationsshall be resolved in a manner that would be consistent with the above-mentioned declared policy and objectives and in furtherance of the intent and

spirit of the FDA Act of 2009. (n)

Sec. 5. Definition of Terms. All terms in Republic Act No. 3720, asamended, otherwise known as the Foods, Drugs and Devices, and CosmeticsAct, and not amended or altered by the FDA Act of 2009 shall retain theirrespective meanings in these Rules and Regulations. In addition, the term:

(a) Accreditation means an attestation conveying formaldemonstration of a laboratorys competence and capability to carry outspecific scientific and technical tests or analytical service with respect tohealth products. (n)

(b) Assay means an analysis to determine the (1) presence of asubstance and the amount of that substance, or (2) the pharmaceuticalpotency of a drug. (Sec. 9, RA 9711)

(c) Assessment is a process undertaken by an accreditation bodyto determine the competence, capability and conformance of a laboratory,based on particular standard(s) and other normative documents for a definedscope of accreditation. It is also a process that systematically examines theshort and long term consequences, in terms of health and resource use, of theapplication of a health technology, a set of related technologies or a

technology related issue. (n)

(d) Authorization means a permission embodied in a documentgranted by the FDA to a natural or juridical person who has submitted anapplication to implement the manufacture, importation, exportation, sale,offer for sale, distribution, transfer, and/or where appropriate, the use,


11/75

3

testing, promotion, advertising, or sponsorship of health products. Theauthorization can take the form of a permit, a license, a certificate ofregistration, of accreditation, of compliance, or of exemption, or any similar

document. (Sec. 9, RA 9711)

(e) "Batch" or Lot means a quantity of any health productsproduced during a given cycle of manufacture. (Sec. 10, RA 3720)

(f) Bioavailability means the rate and extent to which the activeingredient or therapeutic ingredient is absorbed from a drug and becomesavailable at the site of drug action. (Sec. 9, RA 9711)

(g) Bioequivalence means the rate and extent of absorption towhich the drugs do not show a significant difference from the rate and extent

of the listed drug when administered at the same molar dose of thetherapeutic ingredient under similar experimental conditions in either asingle dose or multiple doses. Bioequivalence shall also refer to the absence ofa significant difference on the rate and extent to which the active ingredient(s)of the sample and reference drug becomes available at the site of drug actionwhen administered under the same molar dose and under similar conditions.(Sec. 9, RA 9711)

(h) Cosmeticsmeans any substance or preparation intended to beplaced in contact with the various external parts of the human body or withthe teeth and the mucous membranes of the oral cavity, with a view

exclusively or mainly to cleaning them, perfuming them, changing theirappearance and/or correcting body odor, and/or protecting the body orkeeping them in good condition. (Sec. 9, RA 9711)

(i) Devicemeans medical devices, radiation devices and health-related devices.

(1) Medical device means any instrument, apparatus,implement, machine, appliance, implant, in-vitro reagent or calibrator,software, material, or other similar or related article intended by themanufacturer to be used alone, or in combination, for human beings

for one or more of the specific purpose(s) of diagnosis, prevention,monitoring, treatment or alleviation of disease; diagnosis, monitoring,treatment, alleviation of, or compensation for an injury; investigation,replacement, modification, or support of the anatomy or of aphysiological process; supporting or sustaining life; preventing


12/75

4

infection; control of conception; disinfection of medical devices; andproviding information for medical or diagnostic purposes by means ofin-vitro examination of specimens derived from the human body. This

device does not achieve its primary intended action in or on the humanbody by pharmacological, immunological or metabolic means butwhich may be assisted in intended function by such means.

(2) Radiation device means an electrical or electronicapparatus emitting any ionizing or non-ionizing electromagnetic orparticulate radiation; or any sonic, infrasonic, or ultrasonic wave. Itincludes ionizing radiation-emitting equipment, which is notintentionally designed to produce radioactive materials.

(3) Health-related devicemeans any device not directly used

in health care but has been determined by the FDA to adversely affectthe health of the people. (Sec. 9, RA 9711)

(j) Director-Generalmeans the head of the FDA. (Sec. 9, RA 9711)

(k) Distribute means the delivery or sale of any health product forpurposes of distribution in commerce, except that such term does not includethe manufacture or retail of such product. ( Sec. 9, RA 9711)

(l) Distributor/Importer/Exporter means any establishment thatimports or exports raw materials, active ingredients and/or finished products

for its own use or for wholesale distribution to other establishments or outlets.If the distributor/importer/exporter sells to the general public, it shall beconsidered a retailer. (Sec. 9, RA 9711)

(m) Distributor/Wholesalermeans any establishment that procuresraw materials, active ingredients and/or finished products from localestablishment for local distribution on wholesale basis. (Sec. 9, RA 9711)

(n) Drug means:

(1) Articles recognized in official pharmacopoeias andformularies, including official homeopathicpharmacopoeias, or any documentary supplement to anyof them, which are recognized and adopted by the FDA;


13/75

5

(2) Articles intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man or other animals;

(3) Articles (other than food) intended to affect the structureof any function of the body of human beings or animals; or

(4) Articles intended for use as a component of any articlesspecified in clauses (1), (2), or (3) but do not include devices or theircomponents, parts or accessories. (Sec. 9, RA 9711)

(o) Establishment means a sole proprietorship, a partnership, acorporation, an institution, an association, or an organization engaged in themanufacture, importation, exportation, sale, offer for sale, distribution,donation, transfer, use, testing, promotion, advertising, or sponsorship of

health products, including the facilities and installation needed for itsactivities. (Sec 9, RA 9711)

(p) FDAmeans the Food and Drug Administration created underRepublic Act No. 9711. (Secs. 5 & 9, RA 9711)

(q) FDA Act of 2009 refers to Republic Act No. 9711, otherwiseknown as the Food and Drug Administration Act of 2009. (n)

(r) Fees means either the usual licensing and registration charges,or other related regulatory fees such as fees from sale of publications and

services (including but not limited to laboratory testing fees, trainings, andextension services), assessment fees, fines, penalties, and other fees andcharges outside the usual licensing and registration fees. (Sec. 17, RA 9711)

(s) Food means any processed substance, which is intended forhuman consumption and includes drink for human beings, beverages,chewing gum and any substances, which have been used as an ingredient inthe manufacture, preparation or treatment of food. (Sec. 9, RA 9711)

(t) Food/Dietary Supplement means a processed food productintended to supplement the diet that bears or contains one or more of thefollowing dietary ingredients: vitamin, mineral, amino acid, herb, or otherdietary substance of botanical, animal, artificial or natural origin to increasethe total daily intake in amounts conforming to the latest Philippinerecommended energy and nutrient intakes or internationally agreedminimum daily requirements. It usually is in the form of capsules, tablets,


14/75

6

liquids, gels, powders or pills and is not represented for use as a conventionalfood or as the sole item of a meal or diet or a replacement for drugs andmedicines. (Sec. 9, RA 9711)

(u) Foods, Drugs and Devices, and Cosmetics Actrefers to RepublicAct No. 3720, as amended by Executive Order 175 S. 1987 and the FDA Act of2009. (n)

(v) Health products means food, drugs, cosmetics, devices,biologicals, vaccines, in-vitro diagnostic reagents and household/urbanhazardous substances and/or a combination of and/or a derivative thereof. Itshall also refer to products that may have an effect on health, which requireregulations as determined by the FDA. (Sec. 9, RA 9711)

(w) Health Product Vigilance means the science and activitiesrelating to the detection, assessment, understanding, and prevention ofadverse effects or any other possible problems from health products. (n)

(x) Hazardous Household/Urban Substancemeans:

(1) Any substance or mixture of substances intended forindividual or limited purposes and which is toxic, corrosive, anirritant, a strong sensitizer, is flammable or combustible, or generatespressure through decomposition, heat or other means, if suchsubstance or mixture of substances may cause substantial injury or

substantial illness during or as a proximate result of any customary orreasonably foreseeable ingestion by children, but shall not includeagricultural fertilizer, pesticide, and insecticide and other economicpoisons, radioactive substance, or substances intended for use asfuels, coolants, refrigerant and the like;

(2) Any substance, which the FDA finds to be under thecategories enumerated in clause (1) of this paragraph;

(3) Any toy or other articles intended for use by childrenwhich the FDA may determine to pose an electrical, chemical, physical,or thermal hazard. For this purpose toys and other articles intended foruse by children shall refer to those toys and articles specified to be for12 years of age or under; and,


15/75

7

(4) The term Hazardous Household/Urban Substance shall notapply to food, drugs, cosmetic, devices, or to substances intended foruse as fuels when stored in containers and used in the heating, cooking

or refrigeration system of a house, but such term shall apply to anyarticle which is not, in itself, an agricultural pesticide but which is ahazardous substance, as construed in paragraph (1) of this section, byreason of bearing or containing such harmful substances describedtherein. (Sec. 9, RA 9711)

(y) In-vitro diagnostic reagents means reagents and systemsintended for use in the diagnosis of disease or other conditions, including adetermination of the state of health, in order to cure, mitigate, treat or preventdisease or its sequelae. (Sec. 9, RA 9711)

(z) Labelmeans a display of written, printed, or graphic matter onthe immediate container of any article and a requirement made by or underauthority of the FDA Act of 2009 or other relevant laws that any word,statement or other information appearing on the label shall not be consideredto be complied with unless such word, statement or other information alsoappears on the outside container or wrapper, if any there be, of the retailpackage of such article, or easily legible through the outside container orwrapper. (Sec. 9, RA 9711)

(aa) Legal Fund means the interest earned from the total retainedincome, net of withholding tax, for use in case of any legal actions filed

against the officials and employees of the FDA in the course of their lawfulperformance of official functions and duties. (Sec. 18, RA 9711)

(bb) Licensingmeans the process of approval of an application tooperate or establish an establishment prior to engaging in the manufacture,importation, exportation, sale, offer for sale, distribution, transfer, and whereapplicable the use, testing, promotion, advertisement, and/or sponsorship ofhealth products. (Sec. 9, RA 9711)

(cc) Manufacturer, in relation to a health product, means anestablishment engaged in any operation involved in the production of healthproducts including preparation, processing, compounding, formulating,filling, packaging, repackaging, altering, ornamenting, finishing and labelingwith the end in view of its storage, sale or distribution: Provided, That the termshall not apply to the compounding and filling of prescriptions in drugstores


16/75

8

and hospital pharmacies. A trader shall be categorized as a manufacturer.(Sec. 9, RA 9711)

(dd) Misbrandingmeans, in addition to definitions provided in theFoods, Drugs and Devices, and Cosmetics Act and in other relevant laws,giving unsubstantiated claims, misinformation or misleading information onthe label or other information materials. It shall not refer to copyright,trademark, or other intellectual property-like instruments. Furthermore, itshall also not refer to their alleged infringement/s. (Sec. 9, RA 9711).

(ee) Non-consumer users mean pesticide providers, radiationmachine operators, doctors, health workers, and other such person/s whomay be directly or indirectly in contact with or using such health products inthe conduct of their profession or in the course of their work. (n)

(ff) Pharmacovigilance means the science and activities relating tothe detection, assessment, understanding, and prevention of adverse effects orany other possible drug-related problems. (n)

(gg) Post-Market Surveillance refers to activities involved in safety,efficacy, and quality monitoring of health products. This shall also includeamong others adverse events reporting, product safety update reporting,collection and testing of health products in the market. (n)

(hh) Private Testing Laboratory means a legal entity, other than a

government testing laboratory, that engages in the business of conductingtest, calibration, assay, examination, measurements, or analytical serviceswith respect to health products.(n)

(ii) Registrationmeans the process of approval of an application toregister health products prior to engaging in the manufacture, importation,exportation, sale, offer for sale, distribution, transfer, and where applicable,the use, testing, promotion, advertisement, and/or sponsorship of healthproducts. (Sec. 9, RA 9711)

(jj) Retailermeans any establishment, which sells or offers to sellany health product directly to the general public. (Sec. 9, RA 9711)

(kk) Retained Income means all fees, fines, royalties, and othercharges collected by the FDA under existing laws including the interestearned thereon. (Sec. 18, RA 9711)


17/75

9

(ll) Risk Management Planmeans a set of health product vigilanceactivities and interventions designed to identify, characterize, prevent orminimize risks relating to health products , and the assessment of

effectiveness of those interventions. The risk management plan is arequirement for the issuance of the appropriate authorization. (n)

(mm) Special Regulatory Fundmeans the retained income, includinggrants, donations and all other endowments from local and external sources,accepted by the FDA in accordance with pertinent laws, rules and regulationsdeposited in an authorized government depository bank. (Sec. 18, RA 9711)

(nn) Tradermeans any establishment which is a registered ownerof a health product and procures the raw materials and packing componentsand provides the production monographs, quality control standards and

procedures, but subcontract the manufacture of such product to a licensedmanufacturer. In addition, a trader may also engage in the distributionand/or marketing of its products. (Sec. 9, RA 9711)

(oo) Veterinary drugs means drugs intended for use for animalsincluding any drug intended for use in animal feeds but not including animalfeeds within the contemplation of these Rules and Regulations. (Sec. 9, RA9711)

ARTICLE II

A. THE FOOD AND DRUG ADMINISTRATION

Sec. 1. Nature. The FDA is an agency in the Department of Health(DOH) that shall be under the Office of the Secretary of Health. (Sec. 5, RA9711)

Sec. 2. General Powers and Functions. The FDA shall have thefollowing functions, powers and duties:

(a) To administer the effective implementation of the FDA Act of2009, these Rules and Regulations, other relevant laws, and FDA-promulgated issuances; (Sec. 5, RA 9711)

(b) To assume primary jurisdiction in the collection of samples ofhealth products; (Sec. 5, RA 9711)


18/75

10

(c) To analyze, test and/or inspect health products in connectionwith the implementation of the FDA Act of 2009, these Rules and Regulations,other relevant laws, and FDA-promulgated issuances; (Sec. 5, RA 9711)

(d) To establish analytical data to serve as basis for the preparationof health products standards, and to recommend standards of identity, purity,safety, efficacy, quality and fill of container; (Sec. 5, RA 9711)

(e) To issue certificates of compliance with technical requirementsto serve as basis for the issuance of appropriate authorization and spot check for compliance with regulations regarding operation of manufacturers,importers, exporters, distributors, wholesalers, drug outlets, and otherestablishments and facilities of health products, as determined by the FDA;(Sec. 5, RA 9711)

(f) To levy, assess and collect appropriate fees in accordance withthe FDA Act and other relevant laws as may be determined by the FDA; (Sec.5, RA 9711)

(g) To certify batches of anti-biotic and anti-biotic preparation,where applicable, in compliance with the provisions of the FDA Act of 2009,these Rules and Regulations, other relevant laws, and FDA-promulgatedissuances; (Sec. 5, RA 9711)

(h) To conduct appropriate tests on all applicable health products

prior to the issuance of appropriate authorizations to ensure safety, efficacy,purity, and quality; (Sec. 5, RA 9711)

(i) To require all consumers and non-consumer users,manufacturers, processors, traders, sellers, distributors, importers, exporters,wholesalers, and retailers, of health products to report to the FDA anyincident that reasonably indicates that said product has caused or contributedto the death, serious illness or serious injury to a consumer, a patient, or anyperson; (Sec. 5, RA 9711)

(j) To issue cease and desist orders motu proprio or upon verifiedcomplaint in accordance with the FDA Act of 2009, relevant laws, and theseRules and Regulations; (Sec. 5, RA 9711)

(k) After due process, to order the ban, recall, withdrawal and/ordestruction of any health product found to have caused the death, serious


19/75

11

illness or serious injury to a consumer or patient, or is found to be imminentlyinjurious, unsafe, dangerous, or grossly deceptive; (Sec. 5, RA 9711)

(l) To require all concerned to implement the risk managementplan which is a requirement for the issuance of the appropriate authorization;(Sec. 5, RA 9711)

(m) To institute and strengthen the post market surveillance systemin monitoring health products as defined in the FDA Act of 2009, these Rulesand Regulations, other relevant laws, and the FDA-promulgated issuances,and incidents of adverse events involving such products; (Sec. 5, RA 9711)

(n) To develop and issue policies, standards, regulations, andguidelines that would cover establishments, facilities and health products;

(Sec.5, RA 9711)

(o) To develop and issue appropriate authorizations that would coverestablishments, facilities and health products; (Sec. 5, RA 9711)

(p) To conduct, supervise, monitor and audit research studies onhealth and safety issues of health products undertaken by entities dulyapproved by the FDA; (Sec. 5, RA 9711)

(q) To prescribe policies, standards, regulations, and guidelineswith respect to information, advertisements, promotions, sponsorship, and

other marketing instruments or activities about the health products ascovered in the FDA Act of 2009, these Rules and Regulations, other relevantlaws, and FDA-promulgated issuances; (Sec. 5, RA 9711)

(r) To maintain bonded warehouses and/or establish the same,whenever necessary or appropriate, as determined by the Director-General,for confiscated goods in strategic areas of the country, especially at majorports of entry; (Sec. 5, RA 9711)

(s) To periodically review its fees and propose any increase andpromulgate rules and regulations governing the collection of other relatedregulatory fees; (Sec. 17 RA 9711)

(t) To enter, at reasonable hours, any factory, warehouse, orestablishment in which health products are manufactured, processed, packed,or held, for introduction into domestic commerce, or are held after such


20/75

12

introduction, or to enter any vehicle used to transport or hold such healthproducts in domestic commerce; and (2) to inspect, in a reasonable manner,such factory, warehouse, establishment, or vehicle and all pertinent

equipment, finished or unfinished materials, containers, and labeling therein;(Sec. 27, RA 3720)

(v) To create organizational units which are deemed necessary toaddress emerging concerns and to be abreast with internationally acceptablestandards; (Sec 20, RA 9711)

(w) To provide technical assistance, consultative and advisoryservices to stakeholders and other government agencies in theimplementation of laws, rules and regulations pertaining to health products;

(x) To impose administrative penalties/sanctions in accordancewith the FDA Act of 2009 and other relevant laws; (Sec. 13 RA 9711)

(y) To accept grants, donations and other endowments from localand external sources in accordance with pertinent laws, rules and regulations;(n)

(z) To review and recommend its staffing pattern and position titlessubject to the approval of the Secretary of Health; (Sec 8, RA 9711)

(aa) To call upon other government and private testing laboratories,

provided, that private testing laboratories are accredited by the PhilippinesAccreditation Office of the Department of Trade and Industry and the DOHthrough the FDA; (Sec. 20, RA 9711)

(bb) Subject to the approval of the Secretary of Health, to engage theservices of private lawyers/firms to represent officials and employees of theFDA, regardless of their employment status, upon receipt by the FDA officialsor employees of the court notice that a legal action, suit or proceeding is filedagainst them in connection with the lawful exercise of their official functions,duties or responsibilities as FDA officials and employees. Any privatelawyer/firm who/which is connected or related to any regulatedestablishment, including related foundations, shall be disqualified fromrepresenting FDA officials and employees to avoid impropriety and conflictof interest. The costs incurred in connection with such action, suit orproceeding, including attorneys fees, shall be paid from the Legal Fund.


21/75

13

(cc) To exercise such other powers and perform such other functionsas may be necessary to carry out its duties and responsibilities under the FDAAct of 2009, these Rules and Regulations, and other relevant laws or as may

be required by the Secretary of Health. (Sec. 5, RA 9711)

B. RETENTION AND USE OF THE FDA INCOME

Sec. 3. Authority of the FDA to Retain and Utilize its Income. TheFDA is authorized to collect, retain, and utilize or apply all fees, fines,royalties and other charges collected by it underSection 31 of Republic ActNo. 9502, otherwise known as the Universally Accessible Cheaper andQuality Medicines Act of 2008, and other laws that the FDA is mandated toadminister or implement. (Sec. 18, RA 9711)

Sec. 4. Special Regulatory Fund. All income that the FDA is allowedto retain under Section 31 of the Universally Accessible Cheaper and QualityMedicines Act of 2008 andother laws that the FDA is mandated to administeror implement shall, any provision of law to the contrary notwithstanding, bedeposited in an authorized government depository bank as a SpecialRegulatory Fund (SRF). Any interest earned by such fund shall form part ofthe retained income.

Such fund shall be used primarily for the acquisition of office andlaboratory space, human resource development and expansion, purchase of

laboratory equipment and motor vehicles, the upgrading of its currentfacilities and equipment and maintenance, other operating expenses of thevarious laboratory support divisions of the respective Centers, the satellitelaboratories in Davao, Cebu and Subic, and other activities or services of theFDA in the performance of its mandate. (Sec. 18, RA 9711)

Sec. 5. Grants, Donations and All Other Endowments to the SRF.The SRF shall be allowed to accept grants, donations and all otherendowments from local and external sources in accordance with pertinentlaws, rules and regulations. (Sec. 18, RA 9711)

Sec. 6. SRF Depository.Notwithstanding any provision of law tothecontrary, the SRF shall be maintained and deposited:

(a) Directly by the FDA Cashier in any authorized governmentdepository bank under a special fund account to be denominated as FDA(R.A. 9502 and R.A. 9711) Special Regulatory Fund account; and


22/75

14

(b) In any branch of the designated authorized government

depository bank by the designated Collecting Officers of the Field Regulatory

Operations Office through an Inter-branch Deposit to the FDA (R.A. 9502 andR.A. 9711) Special Regulatory Fund account.

The FDA shall maintain separate books of accounts to cover thecollection, retention and utilization or application of all retained income, andlawfully accepted grants, donations and other endowments from local andexternal sources including interest earned by such income, grants, donationsand other endowments. (n)

Sec. 7. Use and Accounting of the SRF. The SRF shall be subject onlyto the general accounting and usual auditing rules and guidelines of the

Commission on Audit. Its retention, use and application shall not be delayed,amended, altered or modified, or affected in any way by an order or directivefrom any executive office, other than the Office of the President or theSecretary of Health. .

The primary purpose of the SRF, as herein stated, shall prevail overany other purpose that may be pursued by the FDA on its own initiative orthrough an order or directive by any higher office. (Sec. 18, RA 9711)

Sec. 8. Legal Fund. There shall also be established a legal fund out ofthe interest earned from the retained income for use in case of legal actions

against the officials and employees of the FDA in the course of the exercise oftheir official functions and duties except for the performance of theresponsibilities of the Bids and Awards Committee members, which iscovered under Article XXIV of Republic Act No. 9184 or the GovernmentProcurement Act. (Sec. 18, RA 9711)

Subject to the approval of the Secretary of Health, the FDA isauthorized to engage the services of private lawyers/firms to representofficials and/or employees of the FDA, regardless of their employment status,upon receipt of the court notice that an action, suit or proceeding is filedagainst said officials and/or employees in connection with the lawful exercise

of their official functions, duties or responsibilities as FDA officials and/oremployees. Any private lawyer/firm who/which is connected or related toany regulated establishment, including related foundations, shall bedisqualified from representing FDA officials and employees to avoidimpropriety and conflict of interest.For this purpose, the FDA shall establish


23/75

15

rules in the use of the Legal Fund and the mechanisms in engaging privatelegal assistance with the prior approval of the Secretary of Health. (n)

Sec. 9. Reporting Requirement. At the end of any fiscal year, theFDA shall submit to the Secretary of Health, the Secretary of Budget andManagement, and the Congressional Oversight Committee, created underSection 23 of the FDA Act of 2009, a report on collections and retained incomeas well as how the funds were utilized, including its accomplishments. (Sec.18, RA 9711)

C. COMMON PROVISIONS CONCERNING QUALIFICATIONS,DISQUALIFICATIONS, PRE-REQUISITES, APPOINTMENT OF

FDA OFFICERS, PERSONNEL, STAFF AND EMPLOYEES

Sec. 10. Appointment of, and Disciplinary Action Against, AllPersonnel. The appointment of, and disciplinary action against, all officials,personnel, staff and employees in the FDA shall be in accordance with theFDA Act of 2009, these Rules and Regulations, and relevant civil service laws,rules and regulations. (n)

Sec. 11. Authority to Appoint the Director-General and DeputyDirector-Generals. The Director-General and the two (2) Deputy Director-Generals shall be appointed by the President of the Republic of thePhilippines. (Sec. 7, RA 9711)

Sec. 12. Authority to Appoint Officials in Director and Assistant-Director Levels.The Secretary of Health shall appoint all FDA directors andassistant directors. (n)

Sec. 13. Authority to Appoint Officials and Other Personnel andEmployees Below the Assistant-Director Level. The Director General shallappoint all other officials, personnel and employees, below the Assistant-Director level and in coordination with the Secretary of Health. (Sec. 7, RA9711)

Sec. 14. Inhibitions Against Officials and Employees of the FDA.All prohibitions governing the conduct of national public officials andemployees relating to prohibited business and pecuniary interests soprovided in Republic Act 6713, otherwise known as the Code of Conduct andEthical Standards for Public Officials and Employees, and other laws, rules


24/75

16

and regulations shall also be applicable to the FDA officials and employees.(n)

Sec. 15. Director-General and Deputy Director-Generals: ProhibitionAgainst Management and Supervisory Personnel Formerly Employed inRegulated Establishments. Any person, who was previously employedin a regular full-time capacity, regardless of its consultative designation, athigher management supervisory levels in regulated establishments, includingrelated foundations, shall be disqualified from appointment as Director-General and Deputy Director-General within three (3) years from terminationof employment with the said establishment or foundation. (Sec. 7, RA 9711)

Sec. 16. Director-General and Deputy Director-Generals: Declarationof any Conflict of Interest. The Director-General and the two (2) Deputy

Director-Generals shall, upon assumption into office, declare any conflict ofinterest with any establishment covered by the FDA, including theirfoundations. (Sec. 7, RA 9711)

Sec. 17. Publication of Vacancies. The FDA officer in charge ofpersonnel, or his duly designated official, shall post in three (3) conspicuousplaces of the FDA offices, for a period of ten (10) days, a complete list of allexisting vacant positions in the FDA which are authorized to be filled, and totransmit a copy of such list and the corresponding qualification standards tothe Civil Service Commission not later than the tenth day of every month.Vacant positions shall not be filled until after publication: provided, however,

the following are vacant unfilled positions that are not subject to thepublication requirement:

(a) Primarily confidential;(b) Policy-determining;(c) Highly technical;(d) Co-terminus with that of the appointing authority; or(e) Limited to the duration of a particular project. (Sec. 2, RA 7041)

ARTICLE III

OFFICE OF THE DIRECTOR-GENERAL

Sec. 1. Qualifications of the Director-General. The Director-Generalshall have the rank of an Undersecretary. In addition to the civil service


25/75

17

eligibility requirements pertaining to the rank of Undersecretary, the DirectorGeneral shall have the following qualifications:

(a) He/she preferably possess either a university degree inmedicine or at least the relevant masters degree in pharmaceutical sciences orallied sciences, or equivalent executive course in any regulatory management;and,

(b) He/she shall have management experience in his/her field ofdiscipline or profession and in any development, manufacturing, regulatorywork or quality assurance of products as covered in the FDA Act of 2009 andthese Rules and Regulations.

Article II.C of these Rules and Regulations shall likewise apply. ( Sec. 7,

RA 9711).

Sec. 2. Duties and Functions of the Director-General. As head ofthe FDA, the Director-General shall exercise the following powers andperform the following duties and functions:

(a)Administrative Powers, Duties and Functions:(1) To determine the needed personnel of the FDA and

appoint personnel below the Assistant-Director level in accordancewith the FDA Act of 2009, these Rules and Regulations, and the civilservice rules and regulations; (Sec. 7, RA 9711)

(2) Upon the recommendation of the Deputy Director-General for Field Regulatory Operations Office, to establish additionalregional field/satellite laboratories in regions where the same isdeemed necessary. (n)

(3) Upon approval of the Secretary of Health, to establishadditional testing laboratories of the FDA as may be necessary. (Sec.20, RA 9711)

(4) To call upon other government and private testing

laboratories, provided that private testing laboratories are accreditedby the Philippine Accreditation Office (PAO) of the Department ofTrade and Industry (DTI) and the DOH through the FDA. (Sec. 20, RA9711)


26/75

18

(5) To recommend for the approval of the Secretary ofHealth any proposed increase in licensing and registration fees andcharges and to promulgate rules and regulations governing the

collection of other related regulatory fees. (Sec. 17, RA 9711)

(6) To create or abolish and subject to the approval of theSecretary of Health, any organizational unit deemed necessary toaddress emerging concerns and/or to be keep abreast withinternationally acceptable standards. (Sec. 20, RA 9711).

(b) Quasi-Judicial Powers, Duties and Functions:

(1) To render decisions on actions or complaints before theFDA pursuant to the FDA Act of 2009, these Rules and Regulations,

other existing laws, and FDA-promulgated issuances. (n)

(2) To hold in direct or indirect contempt any person whodisregards orders or writs issued by the FDA and impose theappropriate penalties following the same procedures and penaltiesprovided in the Rules of Court. (Sec. 14, RA 9711)

(3) To administer oaths and affirmations and issue subpoenaduces tecum and subpoena ad testificandum requiring the production ofsuch books, contracts, correspondence, records, statement of accountsand other documents and/or the attendance and testimony of parties

and witnesses as may be material to any investigation conducted bythe FDA. (Sec. 14, RA 9711)

(4) To obtain information from any officer or office of thenational or local governments, government agencies and itsinstrumentalities. (Sec. 14, RA 9711)

(5) To issue orders of seizure, to seize and hold in custodyany article or articles of food, device, cosmetics, household hazardoussubstances and health products that is adulterated, counterfeited,misbranded or unregistered, or drug, in-vitro diagnostic reagents,

biologicals, and vaccine that is adulterated or misbranded, whenintroduced into domestic commerce pending the authorized hearingunder the Foods, Drugs and Devices, and Cosmetics Act, and RepublicAct No. 7394, otherwise known as the Consumers Act of thePhilippines. (Sec. 14, RA 9711)


27/75

19

(6) To impose the following administrativesanctions/penalties, after observance of and compliance with dueprocess:

(i) Cancellation of any authorization which may havebeen granted by the FDA, or suspension of the validity thereoffor such period of time as he/she may deem reasonable, whichshall not exceed one (1) year;

(ii) A fine of not less than Fifty Thousand Pesos(PhP50,000.00), but not more than Five Hundred ThousandPesos (PhP500,000.00). An additional fine of not more than OneThousand Pesos(PhP1,000.00) shall be imposed for each day ofcontinuing violation;and/or

(iii) Destruction and/or appropriate disposition of thesubject health product and/or closure of the establishment forany violation of the FDA Act of 2009, these Rules andRegulations, other relevant laws, and FDA-promulgatedissuances. (Sec. 13, RA 9711)

Regulatory Powers, Duties and Functions:

(1) To issue appropriate authorizations that would coverestablishments, facilities and health products; (Sec. 5, RA 9711)

(2) To determine the establishment and maintenance ofbonded warehouses, including the lease or accreditation of bondedwarehouses, whenever necessary or appropriate, for confiscated goodsin the different regions of the country. (Sec. 5, RA 9711)

(3) To call on the assistance of any department, office oragency and deputized members of the Philippine National Police orany law enforcement agency for the effective implementation of theFDA Act of 2009, these Rules and Regulations, other relevant laws, andFDA-promulgated issuances. (Sec. 14, RA 9711)

(d) Such other powers and duties and functions as may benecessary for the effective implementation of the FDA Act of 2009, these Rulesand Regulations, other relevant laws, FDA-promulgated issuances, and such


28/75

20

other laws that the FDA is tasked to administer or implement. (Sec. 14, RA9711)

Sec. 3. Offices Under the Director-General. The following Officesand Centers in the FDA shall be directly under the control and supervision ofthe Director-General:

(a) Policy and Planning Office;(b) Legal Services Support Center;(c) Administrationand Finance Office;(d) Center for Drug Regulation and Research;(e) Center for Food Regulation and Research;(f) Center for Cosmetics Regulation and Research (to include

hazardous household/urban substances);

(g) Center for Device Regulation, Radiation Health, andResearch; and

(h) Field Regulatory Operations Office. (Secs. 6 of RA 9711)

ARTICLE IV

OFFICE OF THE DEPUTY DIRECTOR-GENERALFOR ADMINISTRATION AND FINANCE

Sec. 1. Qualifications of the Deputy Director-General for

Administration and Finance. In addition to the civil service eligibilityrequirements pertaining to the appropriate salary grade level, the DeputyDirector-General for Administration and Finance shall have the followingqualifications:

(a) He/she must be a certified public accountant or shall possess amasters degree in accounting, management, economics or any businesscourse; and,

(b) He/she must have management experience in a position relatedto his/her field of discipline or profession.

Article II.C of these Rules and Regulations shall likewise apply. (Sec. 7,RA 9711)


29/75

21

Sec. 2. Powers and Functions of the Deputy Director-General forAdministration and Finance. The Deputy Director-General forAdministration and Finance shall have the following powers and functions:

(a) To assist the Director General on all matters related toAdministration and Finance (Sec. 7, RA 9711);

(b) To develop plans and programs relative to Finance andAdministrative management; (n)

(c) To determine and evaluate risk management in coordinationwith other offices within the agency; (n)

(d) To coordinate with the Deputy Director General for Field

Regulatory Offices on matters related to the Administration and Finance; (n)

(e) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

Sec. 3. Offices under the Deputy Director-General forAdministration and Finance. The following divisions shall at least be theoffices directly under the control and supervision of the Deputy Director-General for Administration and Finance:

(a) Human Resource Development Division;

(b) Property and Logistics Management Division;(c) Procurement Division;(d) Human Resource Management Division;(e) Assets and Financial Management Division; and(f) Information and Communication Technology Management

Division. (Sec. 6, RA 9711)

Sec. 4. Powers and Functions of the Offices under the DeputyDirector General for Administration and Finance. The following Officesunder the Deputy Director General for Administrative and Finance shallhave, but not limited to, the following powers and functions:

(a) Human Resource Development Division

(1) To formulate and assess training programs for specificcategories of human resources;


30/75

22

(2) To formulate and implement policies for employeesmerit and awards;(3) To establish career development systems;

(4) To exercise such other powers and perform such otherfunctions as may be assigned or necessary to carry out its duties andresponsibilities.

(b) Property and Logistics Management

Division;

(1) To formulate plans, policies, standards and guidelinesrelated to property and logistics;

(2) To conduct inventory of the property of the agency andprepare the necessary reports;

(3) To maintain and safe keep all the records of the property;

(4) To provide general services to the Centers and Offices ofthe FDA;


(c) Procurement Division

(1) To procure, maintain and manage supplies, materials andservices to support the logistical requirements of the agency;

(2) To act as the FDA Bid and Awards Committee

Secretariat;(3) To exercise such other powers and perform such other

functions as may be assigned or necessary to carry out its duties andresponsibilities.

(d) Human Resource Management Division

(1) To develop and implement policies, standards, rules andregulations on selection, recruitment, deployment and utilization ofhuman resources;

(2) To formulate and implement benefits and compensationpackages for human resources;

(3) To establish an employee grievance procedure inaccordance with existing rules and regulations;

(4) To develop welfare program and packages for FDApersonnel in accordance with existing laws, rules and regulations;


31/75

23


(e) Assets and Financial Management Division

(1) To perform general accounting functions and advisemanagement on financial matters;

(2) To monitor and report the collection of fees from thedifferent Centers and Offices of the FDA;

(3) To allocate funds to different offices, in coordination withthe Policy Planning Office (PPO), and monitor utilization of suchfunds;

(4) To coordinate the preparation and implementation of the

annual and long term budget, financial and work plans of the differentCenters and offices of the FDA;

(5) To collect fees and charges and disburse fund;(6) To exercise such other powers and perform such other

functions as may be assigned or necessary to carry out its duties andresponsibilities.

(f) Information and Communication Technology ManagementDivision

(1) To develop and manage the management information

systems and information technology infrastructures includingtelecommunications services;

(2) To develop and manage the information resources,library services and documents tracking, archiving and disposalservices;

(3) To provide technical assistance, consultancy and advisoryservices in IT acquisition, operation and maintenance;

(4) To maintain a record of all duly registered healthproducts and duly authorized and licensed establishments covered andunder the jurisdiction of the FDA;



32/75

24

ARTICLE V

POLICY AND PLANNING OFFICE

Sec. 1. Policy and Planning Office. There shall be a Policy andPlanning Office (PPO) directly under the control and supervision of the Officeof the Director-General.

The PPO shall be headed by a Director who shall be assisted by anAssistant-Director, both of whom shall be appointed in accordance with thecivil service eligibility requirements appropriate to the salary grade level.(Sec. 6, RA 9711)

Sec. 2. Powers and Functions of the Policy and Planning Office.

The PPO shall have the following powers and functions:

(a) To provide services to the FDA on policy formulation, projectdevelopment, and evaluation, research development and analysis, andcoordination and monitoring;

(b) To monitor the performance of the Product Research andEvaluation and Standards Development Division of each of the Centers;

(c) To formulate, update and conduct advocacy for appropriatelegislation on any matter relating to health products. It shall coordinate with

the executive and legislative branches of the national government and otherstakeholders on matters and issues pertaining to regulation of health productsand health product establishments, and shall manage the legislative-executive liaison process including the monitoring and review of legislativeand executive proposals on legislation of all health products and healthproduct establishments regulation.

The Legal Support Services Center and other Centers shall providetechnical assistance and advisory services to the PPO on matters pertaining tolegislation and regulation of health products and health productestablishments.

(d) To initiate, coordinate and implement the conduct of all relevantpolicy research and development work, pursuant to which it shall maintain adata base of statistics related to health products and supervise the collection,monitoring and publication thereof;


33/75

25

(e) To formulate and conduct advocacy, training and communicationprograms in coordination with other government agencies, non-governmentand private entities and sectors in furtherance of the mandate of the FDA;

(f) To conduct integrated and performance-based administrationplanning and budgeting in consultation with other offices; and

(g) To exercise such other powers and perform such other functions asmay be assigned or necessary to carry out its duties and responsibilities.

Sec. 3. Offices under the PPO. The PPO shall have at least thefollowing divisions:

(a) Policy Division;

(b) Training and Advocacy Division; and(c) Planning and Monitoring Division. (Sec. 6, RA 9711)

ARTICLE VI

LEGAL SERVICES SUPPORT CENTER

Sec. 1. Legal Services Support Center. There shall be a Legal ServicesSupport Center (LSSC), which shall be directly under the control andsupervision of the Office of the Director-General.

The LLSC shall be headed by a Director who shall be assisted by anAssistant-Director. (Sec. 6, RA 9711)

Sec. 2. Qualifications of the Director for Legal Services SupportCenter. In addition to the civil service eligibility requirements appropriate tothe salary grade level, the Director and Assistant-Director of the LSSC shall atleast have the following qualifications:

(a) A lawyer, at least thirty (30) years of age, and who has beenengaged in the practice of law in the Philippines for at least five (5) years; and

(b) A member in good standing of the Integrated Bar of thePhilippines.(n)

Sec. 3. Powers and Functions of the Legal Services Support Center.The LSSC shall have the following powers, duties and functions:


34/75

26

(a) To assist and advise the Director-General in all official legal

matters and quasi-judicial functions; (n)

(b) To provide legal services to the entire FDA in theimplementation of its mandate and objectives under the FDA Act of 2009,these Rules and Regulations, other relevant laws, and FDA-promulgatedissuances; (Sec. 5, RA 9711)

(c) To assist in the promulgation of rules governing the activities ofand rules to be issued in connection with the implementation of the FDA Actof 2009, these Rules and Regulations, and other relevant laws, and interpretlaws and rules affecting health products, regulated establishments andfacilities, andthe operations of the FDA; (Sec. 17, Book IV, EO 292)

(d) To assist the Solicitor General and private lawyers/firms inactions/suits involving the FDA or its officials or employees or act as theirprincipal counsel in all actions/suits taken in their official capacity beforejudicial or administrative bodies; (Sec 17, Book IV, EO 292)

(e) To prepare or review contracts and instruments to which theFDA is a party; (Sec 17, Book IV EO 292)

(f) To coordinate with the PPO in providing technical assistanceand advisory services on existing and proposed legislation and regulation onhealth products and health products establishment; and

(g) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

Sec. 3. Offices under the LSSC. The LSSC shall have at least thefollowing divisions:

(a) Litigation and Enforcement Division;(b) Documentation, Opinion and Contracts Review Division; and(c) Internal Affairs Division. (Sec 6, RA 9711)


35/75

27

ARTICLE VII

THE CENTERS

A. COMMON PROVISIONS FOR THE CENTERS

POWER AND FUNCTIONS OF THE CENTERSSec. 1. The Four Centers. There shall be, under the Office of the

Director-General, four (4) Centers covering the four (4) major productcategories that are regulated under FDA Act of 2009. These four (4) Centersare:

(a) Center for Drug Regulation and Research (that includesveterinary medicine, vaccines and biologicals);

(b) Center for Food Regulation and Research;

(c) Center for Cosmetics Regulation and Research (that includeshousehold hazardous/urban substances); and

(d) Center for Device Regulation, Radiation Health, and Research.

Each Center shall be headed by a Director, to be assisted by an

Assistant-Director, both of whom shall be appointed in accordance with thecivil service eligibility requirements appropriate to the salary grade level.

The officer, staff and personnel complement of each of the Centers,including their respective Divisions, shall be based on the technical and skillrequirements of the work, the volume of work, as well as any emergingconcern, in each major product category covered by the Centers. (Sec. 6, RA9711)

Sec. 2. Powers and Functions of the Centers. Each of these Centers,with respect to its major product category, shall have the following powers

and functions:

(a) To regulate the manufacture, importation, exportation,distribution, sale, offer for sale, transfer, promotion, advertisement,sponsorship of, and/or, where appropriate, the use and testing of healthproducts; (Sec. 6, RA 9711)


36/75

28

(b) To conduct research on the safety, efficacy, and quality of health

products; (Sec. 6, RA 9711)

(c) To institute standards for the safety, efficacy, and quality ofhealth products; (n)

(d) To operate the respective Centers testing and/or calibrationlaboratories; (n)

(e) To evaluate health products and establishments covered by theparticular Center and issue appropriate authorizations, as may be delegated;(n)

(f) To issue authorizations or certificates of registration for allhealth products regulated by each Center; (n)

(g) To conduct audits of regional field offices in coordination withthe Deputy Director General for Field Regulatory Operations Office; (n)

(h) To conduct post market surveillance on health products; (n)

(j) To conduct technology assessment of health products that mayhave the potential to affect human health, whether or not in the market; (n)

(k) To employ a consultative risk management approach todecision-making across all product classes; (n)

(l) To coordinate with PPO in providing technical assistance andadvisory services on matters pertaining to health products and health productestablishments legislation and regulations; (n)

(m) To levy, assess and collect fees;

(n) To provide technical assistance, consultative and advisoryservices to stakeholders and other government agencies in theimplementation of laws, rules and regulations pertaining to health products;(n)


37/75

29

(o) To exercise such other powers and perform such other functionsas may be assigned and necessary to carry out its duties and responsibilities.(n)

DIVISIONS OF EACH CENTERSSec. 3. Division Composition of the Centers. Each of the Centers

shall have, at least, the following divisions:

(a) Licensing and Registration Division;(b) Product Research and Standards Development Division;(c) Laboratory Support Division; and,(d) Risk Management and Surveillance Division. (Sec. 6, RA 9711)

[I]. LICENSING AND REGISTRATION DIVISION

Sec. 4. Powers and Functions of the Licensing and RegistrationDivision. The Licensing and Registration Division of each of the Centers shallhave the following powers and functions, with respect to the major productcategory covered by the respective Centers:

(a) To regulate the manufacture, importation, exportation,distribution, sale, offer for sale, transfer, and use, if applicable, of all healthproducts covered by their respective product category. This provision shallnot include the use of radiation devices, which is provided for under Article

VII E of these Rules; (n)

(b) To evaluate, analyze and/or inspect the respective healthproducts covered by the particular Center for purposes of issuance ofauthorizations, registrations and licenses and in connection with theimplementation of this Act; (Secs. 5 and 6, RA 9711)

(c) To maintain a database of all registered health products andduly authorized and licensed establishments covered and under thejurisdiction of the FDA; (n)

(d) To conduct, monitor, inspect, and evaluate healthestablishments including spot-checking, for the purpose of issuance ofappropriate licenses and authorizations to manufacture, import, export, sale,offer for sale, distribute, and other activities as may be determined byFDA;(Sec. 5, RA 9711);


38/75

30

(e) To require appropriate tests on all applicable health productsprior to the issuance of appropriate authorizations to ensure safety, efficacy,purity, and quality; (Sec. 5, RA 9711)

(f) To require all consumers, non-consumer users, manufacturers,traders, distributors, importers, exporters, wholesalers, retailers, of healthproducts to report to the FDA any incident that reasonably indicates that saidproduct has caused or contributed to the death, serious illness or seriousinjury to a consumer, a patient, or any person; (Sec. 5, RA 9711)

(g) After due process, to recommend the ban, recall, and/orwithdrawal of any health product found to have caused the death, seriousillness or serious injury to a consumer or patient, or is found to be imminentlyinjurious, unsafe, dangerous, or grossly deceptive; (Sec. 5, RA 9711)

(h) To mandate, order, review, and implement a Risk ManagementPlan on any health product for conformance with the FDA standards; (n)

(i) To require the collection and testing of samples of healthproducts and/or the raw materials and/or packaging materials for testingand verification of compliance; (n)

(j) To prescribe standards, guidelines and regulations with respectto information, advertisements and other marketing instruments andpromotion, sponsorship, and other marketing activities as covered by the

FDA Act of 2009, these Rules and Regulations, other relevant laws, and FDA-promulgated issuances; and (Sec. 5, RA 9711)

(k) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

[II] PRODUCT RESEARCH AND STANDARDS DEVELOPMENT DIVISION

Sec. 5. Powers and Functions of the Product Research and StandardsDevelopment Division. The Product Research and Standards Development

Division of each Center shall have the following powers, functions, andresponsibilities with respect to the major product category covered by therespective Centers:

(a) To develop standards and regulations for health products;


39/75

31

(b) To undertake compliance monitoring;

(c) To undertake, when appropriate, oversight/ audit of related

researches that would ensure safety, efficacy and quality of health products;(Sec. 6, RA 9711)

(d) To conduct research and to establish analytical data to serve asbasis for the development of health products standards; (n)

(e) To develop standards and guidelines, with respect toinformation, advertisements and other marketing instruments and promotion,sponsorship, and other marketing activities about the health products; (n) and

(f) To exercise such other powers and perform such other functions

as may be assigned or necessary to carry out its duties and responsibilities. (n)

[III] LABORATORY SUPPORT DIVISION

Sec. 6. Powers and Functions of the Laboratory Support Division.The Laboratory Support Division of each Center shall serve as direct linesupport to the respective Center and shall have the following powers,functions and responsibilities with respect to the major product categorycovered by the respective Centers:

(a) To conduct research and appropriate tests and calibration,analyses and trials of products including, but not limited to, assays; (Sec. 6,RA 9711)

(b) To undertake oversight and/or audit of all satellite laboratories.Provided that, the Center for Drug Regulation and Research shall overseeand/or audit centers conducting bioavailability and bioequivalence tests.(n)

(c) To conduct appropriate tests on all applicable health productsas needed prior to the issuance of appropriate authorizations to ensure safety,efficacy and quality; (n)

(d) To conduct tests, that are not routinely performed in the otherFDA laboratories, for confirmatory and/or investigatory purposes and inorder to resolve disputes in test results, when necessary(n);


40/75

32

(e) To analyze and/or and inspect health products in connectionwith the implementation of the FDA Act of 2009, these Rules and Regulations,other relevant laws, and FDA-promulgated issuances; (n)

(f) To provide technical supervision and monitor the operations ofthe FDA Testing and Quality Assurance Laboratories in Visayas, Mindanao,and Luzon (Subic), as well as, satellite laboratories in the region;

(g) To establish analytical data to serve as basis for the preparationof health products standards, and to recommend standards of identity, purity,safety, efficacy and quality; and (n)

(h) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

Sec. 7. Other Government and Private Testing Laboratories. Othergovernment and duly qualified and accredited private testing laboratoriesmay be called upon to provide support testing, calibration, assay, andexamination of samples and health products, especially in those regionswhere there are no existing FDA laboratories. (n)

[IV]RISKMANAGEMENTANDSURVEILLANCEDIVISION

Sec. 8. Powers and Functions of the Risk Management and

Surveillance Division. The Risk Management and Surveillance Division ofeach of the Centers shall have the following powers and functions withrespect to the major product category covered by the respective Centers:

(a) To implement the post market surveillance system inmonitoring health products and incidents of adverse events involving suchproducts in coordination with the Regional Field Offices; (Sec. 5, RA 9711)

(b) To strategize post market surveillance programs and fact-finding activities, including procedures for inspections based on risk and/orother accepted systems; (n)

(c) To develop a collaborative risk management approach onincidents of adverse events; (n)

(d) To develop and maintain a system for gathering and monitoringinformation on health product risks and actions; (n)


41/75

33

(e) To develop standards on risk management to be followed by all

manufacturers, traders, distributors, importers, exporters, wholesalers and

retailers and, where applicable, users of health products; (n)

(f) To develop a system for reporting adverse events/ incidents forconsumers and non-consumer users; (n)

(g) To conduct medical and other scientific assessments of thesafety and risk of marketed health products; and

(h) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

B. CENTER FOR DRUG REGULATION AND RESEARCH

Sec. 9. Product Jurisdiction. The Center for Drug Regulation andResearch shall regulate the manufacture, importation, exportation,distribution, sale, offer for sale, transfer, promotion, advertisement,sponsorship of, and/or, where appropriate, the use and testing of drugs and,when appropriate, certify batches of antibiotic and antibiotic preparations.

The Center shall likewise conduct research on the safety, efficacy, andquality of drug products, and to institute standards for the same. (Sec. 6, RA

9711)

C. CENTER FOR FOOD REGULATION AND RESEARCH

Sec. 10. Product Jurisdiction. The Center for Food Regulation andResearch shall regulate the manufacture, importation, exportation,distribution, sale, offer for sale, transfer, promotion, advertisement,sponsorship of, and/or, where appropriate, the use and testing of foodproducts and food/dietary supplements.

The Center shall likewise conduct research on the safety, efficacy, andquality of food products and food/dietary supplements, and institutestandards for the same. (Sec. 6, RA 9711)


42/75

34

D. CENTER FOR COSMETICS REGULATION AND RESEARCH

Sec. 11. Product Jurisdiction.The Center for Cosmetic Regulation and

Research, which includes hazardous household and urban substances, shallregulate the manufacture, importation, exportation, distribution, sale, offer forsale, transfer, promotion, advertisement, sponsorship of, and/or, whereappropriate, the use and testing of cosmetics and household hazardous andurban substances.

The Center shall likewise conduct research on the safety, efficacy, andquality of cosmetics and household hazardous substances, and institutestandards for the same. (Sec. 6, RA 9711)

E. CENTER FOR DEVICE REGULATION,RADIATION HEALTH, AND RESEARCH

Sec. 12. Product Jurisdiction. The Center for Device Regulation,Radiation Health, and Research shall regulate the manufacture, importation,exportation, distribution, sale, offer for sale, transfer, promotion,advertisement, sponsorship of, and/or, where appropriate, the use andtesting of devices.

The Center shall likewise conduct research on the safety, efficacy, andquality of devices, and institute standards for the same. (Sec. 6, RA 9711)

Sec. 13. The Radiation Regulation Division. In addition to the fourdivisions as provided for in Sec. 3, Article VII of these Rules and Regulations,the Center for Device Regulation, Radiation Health and Research shall have afifth Division, the Radiation Regulation Division, which shall have thefollowing powers and functions over the use of radiation devices:

(a) To develop policies, standards, regulations, and guidelines onthe use of ionizing and non-ionizing radiation devices in medicine, dentistry,veterinary medicine, commerce and industry, education and training,research, anti-crime, security, household activities, and all other

facilities/establishments and activities where radiation devices are used;

(b) To conduct radiation protection survey and evaluation ofradiation facilities and the activities thereat;


43/75

35

(c) To issue appropriate authorizations for medical and non-medical radiation facilities;

(d) To issue certificates of compliance with technical requirementsas basis for the issuance of appropriate authorization regarding the use ofradiation devices and operation of radiation facilities;

(e) To conduct compliance monitoring of radiation facilities;

(f) To provide technical assistance, consultative and advisoryservices to stakeholders and other government agencies in theimplementation of laws, rules and regulations pertaining to radiationfacilities; and

(g) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities.

ARTICLE VIII

FIELD REGULATORY OPERATIONS OFFICE

A. OFFICE OF THE DEPUTY DIRECTOR-GENERAL

FOR FIELD REGULATORY OPERATIONS

Sec. 1. Qualifications of the Deputy Director-General for FieldRegulatory Operations. In addition to the civil service eligibilityrequirements pertaining to the appropriate salary grade level, the DeputyDirector General for Field Regulatory Operations shall have the followingqualifications:

(a) He/she preferably possess the relevant masters degree inpharmaceutical sciences or allied sciences, or equivalent executive course inany regulatory management; and

(b) He/she shall have management experience in his/her field ofdiscipline or profession and in any development, manufacturing, regulatorywork or quality assurance of products covered by the FDA Act of 2009, theseRules and Regulations, other relevant laws, and FDA-promulgated issuances.


44/75

36

Article II.C of these Rules and Regulations shall likewise apply. (Sec. 7(e), RA 9711)

Sec. 2. Duties and Functions of the Deputy Director-General for FieldRegulatory Operations Office. The Deputy Director-General for FieldRegulatory Operations shall have the following powers, functions andresponsibilities:

(a) To assist the Director-General in all matters relating to thesupervision and control of the Field Regulatory Operations Office; (n)

(b) To have supervision of all Field Regulatory Operations Offices,that shall include, among others, all the Field Offices, Field or SatelliteLaboratories and the Regulatory Enforcement Units; (Sec. 6 RA 9711)

(c) To recommend, to the Director-General, the officer, staff andpersonnel complement of each Regional Field Office, including the respectiveDivisions, based on the volume of work in each Regional Field Office as wellas to address any emerging concern in each particular Regional Field Office;(n)

(d) To monitor collection of fees by the regional field offices; (n)

(e) To recommend, to the Director-General, other government andprivate testing laboratories in the regions qualified and properly equipped to

conduct testing, calibration, assay, and examination of samples and healthproducts; (n) and

(f) To exercise such other powers and perform such other functionsas may be assigned or necessary to carry out its duties and responsibilities. (n)

Sec. 3. Offices under the Deputy Director-General for FieldRegulatory Operations. The following Offices shall be directly under thesupervision and control of the Deputy Director-General for Field RegulatoryOperations:

(a) Regional Field Offices;(b) Field or Satellite Laboratories; and(c) Regulatory Enforcement Units.


45/75

37

B. REGIONAL FIELD OFFICES

OFFICE OF THE DIRECTOR AND ASSISTANT DIRECTORSec. 4. Establishment of Regional Field Office. There shall be

established Field Offices in all of the regions of the country, including theNational Capital Region and the autonomous regions.

A Regional Field Office shall be headed by a Director who shall beassisted by an Assistant-Director, and both shall be appointed in accordancewith the civil service eligibility requirements appropriate to the salary gradelevel. (Sec. 20, RA 9711)

Sec. 5. Powers and Functions of the Regional Field Offices. Field

Offices in all regions of the country shall have the following powers andfunctions in their respective assigned region:

(a) To implement laws, policies, plans, programs, rules andregulations of the FDA in the regional area;

(b) To oversee the operations of the divisions and units of theregional field offices;

(c) To prepare and submit budget proposals for the region to theOffice of the Deputy Director General for Field Regulatory Office, administer

the budget of the regional office, disburse funds pursuant to the approvedwork and financial programs, and administer budget control machinery in theregion;

(d) To administratively support the Regional RegulatoryEnforcement Units (REU) assigned in their respective region; (Sec. 19, RA9711)

(e) To operate satellite laboratories in their respective regions; (n)

(f) To evaluate health products and establishments and issue

appropriate authorizations, as may be delegated; (n)

(g) To levy, assess and collect appropriate fees;

(h) To coordinate with regional offices of other departments,bureaus and agencies in the area;


46/75

38

(i) To coordinate with local government units in the area; and,

(j) To exercise such other powers an

Date post:	15-Oct-2015
Category:	Documents
Upload:	samdelacruz1030
View:	95 times
Download:	0 times

Republic Act No. 9711 the Food and Drug Administration Act of 2009 Implementing Rules and...

Documents