Compiled by- Shamon Ahmad Gaur, Jassjeet Singh Kharha, M.Pharma (Q.A) Chandigarh Group of Colleges, Landra, Mohali(Punjab India) email-shmmon@gmail.com 25/03/2013

WTO,GATT,TRIMS,GATS & SADC

(A) What is the WTO?

“The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. At its heart are the WTO agreements, negotiated and signed by the bulk of the world’s trading nations and ratified in their parliaments. The goal is to help producers of goods and services, exporters, and importers conduct their business”.

Who we are?

There are a number of ways of looking at the World Trade Organization. It is an organization for trade opening. It is a forum(majlis, manch) for governments to negotiate(agreement,batcheet) trade agreements. It is a place for them to settle trade disputes. It operates a system of trade rules. Essentially, the WTO is a place where member governments try to sort out the trade problems they face with each other(country).

What we do?

The WTO is run by its member governments. All major decisions are made by the membership as a whole, either by ministers (who usually meet at least once every two years) or by their ambassadors or delegates (who meet regularly in Geneva).

While the WTO?

WTO is driven by its member states, it could not function without its Secretariat to coordinate the activities. The Secretariat employs over 600 staff, and its experts — lawyers, economists, statisticians and communications experts — assist WTO members on a daily basis to ensure, among other things, that negotiations progress smoothly, and that the rules of international trade are correctly applied and enforced.

Trade negotiations(agreement)

The WTO agreements cover goods, services and intellectual property. They spell(tarika,formula,way) out the principles of liberalization, and the permitted

exceptions. They include individual countries’ commitments to lower customs tariffs(kar,tax) and other trade barriers, and to open and keep open services markets. They set procedures for settling disputes. These agreements are not static; they are renegotiated from time to time and new agreements can be added to the package. Many are now being negotiated under the Doha Development Agenda, launched by WTO trade ministers in Doha, Qatar, in November 2001.

Implementation and monitoring:

WTO agreements require governments to make their trade policies transparent by notifying the WTO about laws in force and measures adopted. Various WTO councils and committees seek to ensure that these requirements are being followed and that WTO agreements are being properly implemented. All WTO members must undergo periodic scrutiny of their trade policies and practices, each review containing reports by the country concerned and the WTO Secretariat.

Dispute settlement

The WTO’s procedure for resolving trade quarrels under the Dispute Settlement Understanding is vital for enforcing(activate rule) the rules and therefore for ensuring that trade flows smoothly. Countries bring disputes to the WTO if they think their rights under the agreements are being infringed. Judgements by specially appointed independent experts are based on interpretations of the agreements and individual countries’ commitments.

Building trade capacity

WTO agreements contain special provision for developing(poor country) countries, including longer time periods to implement(active) agreements and commitments, measures to increase their trading opportunities, and support to help them build their trade capacity, to handle disputes and to implement technical standards. The WTO organizes hundreds of technical cooperation missions to developing countries annually. It also holds numerous courses each year in Geneva for government officials. Aid for Trade aims to help developing countries develop the skills and infrastructure needed to expand their trade.

Trade and Investment :

There are three main areas of work in the WTO on trade and investment:

• A Working Group established in 1996 conducts analytical work on the relationship between trade and investment.

• The Agreement on Trade-Related Investment Measures (“TRIMs Agreement”), one of the Multilateral Agreements on Trade in Goods, prohibits trade-related investment measures, such as local content requirements, that are inconsistent with basic provisions of GATT 1994.

• The General Agreement on Trade in Services addresses foreign investment in services as one of four modes of supply of services.

The Three Areas Of Work On Trade And Investment In The WTO

1. Working Group on the relationship between trade and investment.

The Working Group on the Relationship between Trade and Investment was established during the 1996 Ministerial Conference in Singapore to examine the relationship between trade and investment. There is no negotiation of new rules or commitments.

2. Agreement on Trade-Related Investment Measures (TRIMs)

This Agreement, negotiated during the Uruguay Round, applies only to measures that affect trade in goods. Recognizing that certain investment measures can have trade-restrictive and distorting effects, it states that no Member shall apply a measure that is prohibited by the provisions of GATT Article III (national treatment) or Article XI (quantitative restrictions). Examples of inconsistent measures, as spelled out in the Annex's Illustrative List, include local content or trade balancing requirements. The Agreement contains transitional arrangements allowing Members to maintain notified TRIMs for a limited time following the entry into force of the WTO (two years in the case of developed country Members, five years for developing country Members, and seven years for least-developed country Members). The Agreement also establishes a Committee on TRIMs to monitor the operation and implementation of these commitments.

3. Trade and Investment in the context of the GATS

The mandate Overview of the GATS and rules for growth and investment Links to the section on GATS and rules for growth and investment section of the

WTO Guide “Understanding the WTO”

(B)-The General Agreement on Tarrifs and Trade (GATT) :

GATTemerged from the “ashes of Havana Charter”. The world had experienced the rigours and problems of an extensive pattern of trade barriers in 1930’s and during the Second World War. So the Allied Powers thought of having a liberal world trading system after World War II. For this purpose the International Conference on Trade and Employment was held inHavana in the winter of 1947-48. Fifty three nations drew up and signed a charter for establishing aninternational Trade Organization (ITO). But the UScongress did not ratify the Havana Charter with the result that the ITO never came into existence. Simultaneously twenty three nations agreed to continue extensive tarrif negotiations for trade concessions at Geneva which were incorporated in a General Agreement on Tarrifs and Trade (GATT). This was signed on October 30, 1947 and came into force from January 1, 1948.

GATT is a multilateral treaty which has been signedby 92 governments, at present known as “Contracting Parties”. Thirty one other countries apply GATT rules defacto. The GATT is neither an organisation nor a court of justice. It is simply a multinational treaty which now covers 50 percent of the world trade. It is a decision making body with a code of rules for the conduct of international trade and a mechanism for trade liberalization. It is a forum where the contracting parties meet from time to time to discuss and solve their trade problems, and also negotiate to enlargetheir trade. The GATT rules provide for the settlement of trade disputes, call for consultations, wave trade obligations and even authorize retaliatory measures.

The GATT is permanent organization having a permanent council of Representatives with head quarters at Geneva. Its function is to call international conferences to decide on trade liberalization on a multilateral basis.

Objectives of GATT:

The basic objectives of GATT were to serve as clearing house for the member countries regarding the issue of world trade. In other words, GATT is a forum where members of

GATT will make negotiations regarding problems of trade i.e. removal of trade restrictions or liberalization of world trade. More broadly the basic objective of GATT was to liberalize world trade in such a way that no country should provide preferential Treatment to the other country. It means that this institution is aimed at abolishing discrimination regarding trade concessions and facilities between member countries. It means that members of GATT have to accept “Most Favoured Nation Clause”. This clause means that “a member country is agreed upon that it will not provide any facility or concession to any member country which it is not providing to other members of GATT.

Another objective of the GATT is grant protection to domestic industry through fundamental component of GATT is a negotiated balance of mutual tarrif concessions among contracting parties. The contracting parties commit themselves not to raiseimport tarrifs above the negotiated rates. In this way it tries to protect domestic industries of all contracting parties.

The ultimate aim of establishing liberal world trading system is to raise living standard, ensure full employment through a steadily growth effective demand and real income, develop fully the resources of the world and expand the production and exchange of goods on global level.

(C)-Trade Related Investment Measures(TRIMS): “The Agreement on Trade Related Investment Measures (TRIMs) are rules that apply to the domestic regulations a country applies to foreign investors, often as part of an industrial policy. The agreement was agreed upon by all members of the World Trade Organization. (The WTO wasn't established at that time, it was its predecessor, the GATT (General Agreement on Trade and Tariffs). The WTO came about in 1994-1995”.

Policies such as local content requirements and trade balancing rules that have traditionally been used to both promote the interests of domestic industries and combat restrictive business practices are now banned.

Trade Related Investment Measures is the name of one of the four principal legal agreements of the WTO trade treaty.

TRIMs are rules that restrict the preference of domestic firms and thereby enable international firms to operate more easily within foreign markets.

Transitional period Exceptions for developing countries

Equitable provisions

Measures specifically prohibited by the TRIMs Agreement need not be eliminated immediately, although such measures must be notified to the WTO within 90 days after the entry into force of the TRIMs Agreement. Developed countries will have a period of two years in which to abolish such measures; in principle, developing countries will have five years and least-developed countries will have seven years.

Developing countries are permitted to retain TRIMs that constitute a violation of GATT Article III or XI, provided the measures meet the conditions of GATT Article XVIII which allows specified derogation from the GATT provisions, by virtue of the economic development needs of developing countries.

To avoid damaging the competitiveness of companies already subject to TRIMs, governments are allowed to apply the same TRIMs to new foreign direct investment during the transitional period described in (1) above.

Local content requirement

Trade balancing requirements

Foreign exchange restrictions

Export restrictions (Domestic sales requirements)

Measures requiring the purchase or use by an enterprise of domestic products, whether specified in terms of particular products, in terms of volume or value of products, or in terms of a proportion of volume or value of its local production.

1.Measures requiring that an enterprise's purchases or use of imported products be limited to an amount related to the volume or value of local products that it exports III:4)2.Measures restricting the importation by an enterprise of products used in or related to its local production, generally or to an amount related to the volume or value of local production

Measures restricting the importation by an enterprise of products (parts and other goods) used in or related to its local Production by restricting its access to foreign exchange to an amount related to the foreign exchange inflows attributable(vishes) to the enterprise. (Violation of GATT Article XI:1)

Measures restricting the exportation or sale for export by an enterprise(business man) of products, whether specified in terms of particular products, in terms of volume or value of products, or in terms of a proportion of volume or value of its local production. (Violation of GATT Article XI:1)

The General Agreement on Tariffs(tax) and Trade (GATT) was a multilateral(multi object) agreement regulating international trade. According to its preamble, its purpose was the "substantial reduction of tariffs and other trade barriers and the elimination of preferences, on a reciprocal and mutually advantageous basis ." It was negotiated(fesla) during the United Nations Conference on Trade and Employment and was the outcome of the failure of negotiating governments to create the International Trade Organization (ITO). GATT was signed in 1947 and lasted until 1994, when it was replaced by the World Trade Organization in 1995. The original GATT text (GATT 1948) is still in effect under the WTO framework, subject to the modifications of GATT 1994.

GATT and the World Trade Organization(WTO):

In 1993, the GATT was updated to include new obligations upon its signatories (authority). One of the most significant changes was the creation of the World Trade Organization (WTO). The 75 existing GATT members and the European Communities became the founding members of the WTO on 1 January 1995. The other 52 GATT members rejoined the WTO in the following two years (the last being Congo in 1997). Since the founding of the WTO, 21 new non-GATT members have joined and 29 are currently negotiating membership. There are a total of 157 member countries in the WTO, with Russia and Vanuatu being new members as of 2012.

Of the original GATT members, Syria and the SFR Yugoslavia have not rejoined the WTO. Since FR Yugoslavia, (renamed to Serbia and Montenegro and with membership negotiations later split in two), is not recognised as a direct SFRY successor state; therefore, its application is considered a new (non-GATT) one. The General Council of WTO, on 4 May 2010, agreed to establish a working party to examine the request of Syria for WTO membership. The contracting parties who founded the WTO ended official agreement of the "GATT 1947" terms on 31 December 1995. Serbia and Montenegro are in the decision stage of the negotiations and are expected to become the newest members of the WTO in 2012 or in near future.

Whilst GATT was a set of rules agreed upon by nations, the WTO is an institutional body. The WTO expanded its scope from traded goods to include trade within the service sector andintellectual property rights. Although it was designed to serve multilateral agreements, during several rounds of GATT negotiations (particularly the Tokyo Round) plurilateral agreements created selective trading and caused fragmentation among members. WTO arrangements are generally a multilateral agreement settlement mechanism of GATT.

(D)- General Agreement on Trade in Services (GATS):

• The General Agreement on Trade in Services (GATS) is a treaty of the World

Trade Organization (WTO) that entered into force in January 1995 as a result of the Urugua

Round negotiations(agreement). The treaty(agreement) was created to extend the

multilateral(multi bases/udese) trading system to service sector, in the same way the General

Agreement on Tariffs and Trade (GATT) provides such a system for merchandise(sode baji)

trade.

• All members of the WTO are signatories to the GATS.

• The basic WTO principle of most favoured nation (MFN) applies to GATS as well.

However, upon accession, Members may introduce temporary exemptions to this rule.

GATS 3 :“Members,Recognizing the growing importance of trade in services for the

growth and development of the world economy; Wishing to establish a multilateral(multi

Branch) framework of principles and rules for trade in services with a view to the

expansion(mony spend) of such trade under conditions of transparency and progressive

liberalization and as a means of promoting the economic growth of all trading partners

and the development of developing countries”,

Desiring the early achievement of progressively higher levels of liberalization of trade in

services through successive rounds of multilateral negotiations aimed at promoting the interests

of all participants on a mutually advantageous basis and at securing an overall balance of rights

and obligations, while giving due respect to national policy objectives;

Recognizing the right of Members to regulate, and to introduce new regulations, on the supply

of services within their territories in order to meet national policy objectives and, given

asymmetries existing with respect to the degree of development of services regulations in

different countries, the particular need of developing countries to exercise this right;

Desiring to facilitate the increasing participation of developing countries in trade in services

and the expansion of their service exports including, inter alia, through the strengthening of

their domestic services capacity and its efficiency and competitiveness;

Taking particular account of the serious difficulty of the least-developed countries in view of

their special economic situation and their development, trade and financial needs;

Hereby agree as follows:

GATS 4 ;PART I: SCOPE AND DEFINITION

Article I: Scope and Definition

This Agreement applies to measures by Members affecting trade in services.

For the purposes of this Agreement, trade in services is defined as the supply of a service:

from the territory(area,Halka) of one Member into the territory of any other Member;

in the territory of one Member to the service consumer of any other Member;

by a service supplier of one Member, through commercial presence in the territory of any

other Member;

by a service supplier of one Member, through presence of natural persons of a Member in the

territory of any other Member. For the purposes of this Agreement:

"measures by Members" means measures taken by: central, regional or local governments and

authorities; and

(ii) non-governmental bodies in the exercise of powers delegated by central, regional or local

governments or authorities;

In fulfilling its obligations and commitments under the Agreement, each Member shall take

such reasonable measures as may be available to it to ensure their observance by regional and

local governments and authorities and non-governmental bodies within its territory;

"services" includes any service in any sector except services supplied in the exercise of

governmental authority;

"a service supplied in the exercise of governmental authority" means any service which is supplied neither on a commercial basis, nor in competition with one or more service suppliers.

(E)- SADC GUIDELINES(Southern African Development Community)

On Import Andexport Procedures For Pharmaceutical Products AUTHORISED IMPORTER Means an individual or company or similar legal entity importing or seeking to import a pharmaceutical or veterinary product. A "licensed" or "registered" importer is one who has been granted a licence or registration status for the purpose. AUTHORISED EXPORTER

Means an individual or company or similar legal entity exporting or seeking to export a pharmaceutical or veterinary product. A "licensed" or "registered"exporter is one who has been granted a licence or registration status for the purpose. REGISTRATION Any statutory system of approval required at national level as a precondition for introducing a pharmaceutical product on the market PRODUCT. LICENCE. Registration certificate an official document issued by the competent drug regulatory authority for the purpose of the marketing or free distribution of a product. PRODUCT INFORMATION The approved product information for health professionals and the public as approved in the exporting country MANUFACTURE includes all operations of purchase of materials and products, production, quality control, release, storage, shipment of finished products, and related controls REGISTERED, LICENSED, AUTHORISED These words are used in these guidelines as if they are interchangeable CONTROLLED SUBSTANCES Mean narcotic drugs and psychotropic substances under international control WHO Stands for World Health Organisation SADC Stands for Southern African Development Community BATCH CERTIFICATE Means Certificate of Analysis LEGAL CONSIDERATIONS: All transactions concerning the importation of consignments of pharmaceutical products should be conducted through Ministry of Health, mission hospitals, any other person authorised by the DRA or through independent authorised pharmaceutical importers licensed by the relevant drug regulatory authority for this purpose. Unless otherwise specified, only licensed/approved medicinal products will be permitted to be imported (or exported) within the region. The importation of all consignments of pharmaceutical products should be channeled exclusively through the designated ports of entry and will be cleared by customs in consultation with the inspectorate of the respective DRA. Medicines and their documentation shall not be manipulated while being transported through member states in bonded warehouses.

An application for the issue of an import or export permit shall be made by an authorised importer to the respective Drug Regulatory Authority in a prescribed form. The period of validity of the import and export permits shall be determined by the respective Drug Regulatory Authority. This period shall not exceed six(6) months. An applicant for an import permit must be in possession of an import licence issued by the relevant drug regulatory authorities. The validity of the licence shall be determined by the respective Drug Regulatory Authority. The Pharmaceutical Import Licence shall be subject to renewal upon expiry. No importation or exportation of pharmaceutical products shall be done by post.

IMPLEMENTATION OF CONTROLS: The drug regulatory authorities shall provide comprehensive and frequently updated lists of licensed or notified medicinal products and authorised dealers/importers which should be easily accessible to designated ports of entry and authorised dealers. Notifications on any product licences that have been withdrawn on grounds of safety or quality and confirmed cases of imported counterfeit products and other illicit activities should immediately be communicated to all the DRAs. Customs officials in collaboration with a pharmaceutical inspector will carry out physical examination of all imported consignment of medicinal products and their documentation. Where necessary, the pharmaceutical inspector will carry out random sampling of pharmaceutical products in accordance with laid down guidelines on sampling of medicinal products imported into the country for drug analysis. Consignments of any counterfeit products should be forfeited and destroyed as per provisions in the legislation. Other Drug Regulatory Authorities and the WHO through the Division of Drug Management and Policies should immediately be notified of these confirmed cases of counterfeit products. Consignments of pharmaceutical products should be accorded high priority for clearance through ports of entry. Since pharmaceutical products tend to degrade on storage and some need to be kept in cold storage, ports of entry need to be provided with secure storage facilities including refrigerated compartments. The authorised importer should alert customs officials in advance of the anticipated arrival of consignments in order that they can be transferred to the designated storage facilities without breaking the cold chain Exemptions From Requirements Of A Pharmaceutical Import/Export Licences Importation of donated pharmaceutical products shall be dealt with in accordance with SADC guidelines on donated drugs. Importation Of Pharmaceutical Products In Emergency Situations The respective DRAs will reserve discretionary powers to waive product licensing requirements in respect of consignments of pharmaceutical products imported in response to emergency situations and, exceptionally, in response to requests from clinicians for limited supplies of unlicensed medicines needed for treatment of specific named patients.

Importation Of Pharmaceutical Products For Personal Use Importation of pharmaceutical products for personal use or for use by a member of a family will be limited for 28 days after which prior approval from the DRA shall be required. It must be emphasized

that the intent of the ‘personal use importation’ guidance is to generally permit the DRA exercise its enforcement discretion for medicines that may not otherwise be available in the country. Importation Of Medicines To Be Used For Clinical Trials Authorisation to be sought from the DRA for the purposes. “Importation Of Biotechnological/Biological/Blood Products, Seram And Vaccines” Authorisation to be sought from the DRA for the purposes. DOCUMENTATION: The authorised importer shall be required to furnish customs and DRA officials with: certified copies of documents issued by the relevant DRA attesting that the importer is : an authorised importer (produce a valid Pharmaceutical Import Licence) importing a medicine that is duly authorised/ licensed (produce a valid product licence) batch certificate issued by the manufacturer in conformity with the requirements of WHO Certification Scheme relevant invoice or bill together with an import permit or export permit APPLICATION FOR ISSUE OF AN IMPORT PERMIT • An application accompanied by a prescribed fee for issue of an import permit shall be made on the prescribed form backed by legislation. • An application for issue of an import permit shall state, for each medicine to be imported at least the following: • generic name or International Non-proprietary Name (INN) • b) strength and dosage form • name and strength of each ingredient; in case of a product containing more than one ingredient • trade name or proprietary name; if any pharmacopoeia specification of the medicine, where applicable total quantity to be imported • name and address of the supplier • h) name and address of the manufacturer • country of origin • route of entry • licence/ registration number • Cost, insurance, freight (CIF) value • expected date of arrival • A separate import permit for controlled substances will apply as prescribed by the national legislation and applicable treaty obligations. The application shall be accompanied by copies of the proforma invoices

APPLICATION FOR ISSUE OF AN EXPORT PERMIT

• An application accompanied by a prescribed fee for issue of an export permit • shall be made on the prescribed form backed by legislation. • An application for issue of an export permit shall state, for each medicine to be exported at least

the following: • generic name or International Non-proprietary Name (INN) • strength and dosage form • name and strength of each ingredient; in case of a product containing more than one ingredient • trade name or proprietary name; if any pharmacopoeia specification of the medicine, where

applicable total quantity to be exported • name and address of the exporter • name and address of the manufacturer • name and address of consignee • country of consignee • route of dispatch • licence/registration number • cost, insurance, freight (CIF) value • expected date of dispatch

The application shall be accompanied by copies of the purchase orders In conclusion, importation of drugs that lack approval and are not in line with these guidelines whether for personal use or otherwise will be considered as illegal importation and could be refused entry into any of the SADC countries or seized by customs officials. 10 Licence No. Registration No. Pharmaceutical Import Licence Messrs (Name of Importer)………………………………………………………………… …………………………………………………………………………………………………………………………………………….. of (address i.e. Plot No. Street/Road, Town/City. P.O. Box) ……………………….…..……………………………………..…… ……………………………………………………………………………………………………………………...…..…..….….……… ……………………………………………… …………………………………………….………………………….…………………... Carrying on business as ………………………………………………..….………….……………..………………………………... Are hereby authorised to Import Pharmaceutical Products (Medicines, herbal medicines and allied substances) into the Country

during the calendar year……………………..…………………..……………………………………….…………….. Name of Supervising Pharmacist ………………………………………………….. Registration Certificate No: ……………………………………………….. Conditions imposed by the Pharmaceutical Regulatory Authority (refer to notes overleaf). This licence is valid from……….. to… ………………. …………….. Registrar of medicines Date stamp Date Issued …………………………. Overleaf notes Conditions of issue / renewal for import licence Consideration of an application for issue / renewal may take advantage to impose any new conditions or insist on any aspects that had been overlooked previously or are brought about due to new or amended legislation or policy. Conditions for Premises ��Compliance with minimum requirements ��Valid local authority licence ��No adverse report since the previous issue regarding e.g. wrongful dealing in medicines, lack of proper management and control of the pharmaceutical business, etc ��Appropriately registered pharmacist with practicing license from Medical Council of a Country and with no recorded acts of professional misconduct over the previous year (those that may or may not warrant revocation of practicing licence). ��Appropriate renewal forms and fees submitted well before previous licence lapsed ��No changes to the previous conditions under which licence was issued. Conditions for Amendments All amendments to conditions under which an import licence was issued must be formally applied for and approved. A processing fee must be paid. An applicant must not effect any changes without prior approval except for situations where e.g. a registered pharmacist leaves without notice and a locum tenens is in attendance for a period less than four weeks, changes of directorship in a company without changes in the effective supervision of the business. Changes of ownership, effective directorship of a company, structural changes to the premises, changes in effective supervision of business, relocation to another premises require prior and written approval. Validity Certificates are valid for one calendar year from time of issue or until formally cancelled by the issuing authority. An annual renewal must be applied for each time an applicant wishes its licence to be renewed. Once a licence has lapsed due to failure to renew by the licensee, there should not be a requirement for a formal notification of intent by the licensing authority to consider the licence invalid.

Suspension or cancellation of licences A licence may be cancelled under the following situations; ��Failure to comply with specific conditions of licensing ��Wrongful dealing in medicines, herbal medicines and allied substances ��Unauthorized change of premises ��Failure to comply with other legislation e.g. local authority licensing, health requirements that were part of the conditions of initial approval A formal and legislated appeal process must be conducted prior to cancellation of a licence. Licence No. Registration No. Pharmaceutical Export Licence Messrs (Name of Exporter)……………………………………………………………… ……..………………. …………………………………………………………………………………………………………………………………………….. of (address i.e. Plot No. Street/Road, Town/City. P.O. Box)…………………….………………………………………………….. ……………………………………………….…………………………………………………………………………………………… ……………………………………………… …………………………..…………………………………………….…………………... Carrying on business as ……………………… ……………………………………….……………..………………………………... Are hereby authorised to export Pharmaceutical Products (Medicines, herbal medicines and allied Substances) during the calendar year…………………………..……………………………………….…………….. Name of Supervising Pharmacist ………………………………………………….. Registration Certificate No: ……………………………………………….. Conditions imposed by the Drug Regulatory Authority (refer to notes overleaf). This licence is valid from…………. to………….…………………. ………………. …………….. Registrar of medicines Date Issued …………….…… Date stamp Overleaf notes Conditions of issue / renewal for export licence Consideration of an application for issue / renewal may take advantage to impose any new conditions or insist on any aspects that had been overlooked previously or are brought about due to new or amended legislation or policy.

Conditions for Premises ��Compliance with minimum requirements ��Valid local authority licence ��No adverse report since the previous issue regarding e.g. wrongful dealing in medicines, lack of proper management and control of the pharmaceutical business,etc ��Appropriately registered pharmacist with practicing license from Medical Council and with no recorded acts of professional misconduct over the previous year (those that may or may not warrant revocation of practicing licence). ��Appropriate renewal forms and fees submitted well before previous licence lapsed ��No changes to the previous conditions under which licence was issued. Conditions for Amendments All amendments to conditions under which an export licence was issued must be formally applied for and approved. A processing fee must be paid. An applicant must not effect any changes without prior approval except for situations where e.g. a registered pharmacist leaves without notice and a locum tenens is in attendance for a period less than four weeks, changes of directorship in a company without changes in the effective supervision of the business. Changes of ownership, effective directorship of a company, structural changes to the premises, changes in effective supervision of business, relocation to another premises require prior and written approval. Validity: Licences are valid for one calendar year from time of issue or until formally cancelled by the issuing authority. An annual renewal must be applied for each time an applicant wishes its licence to be renewed. Once a licence has lapsed due to failure to renew by the licensee, there should not be a requirement for a formal notification of intent by the licensing authority to consider the licence invalid. Suspension or cancellation of licences A licence may be cancelled under the following situations; ��Failure to comply with specific conditions of licensing ��Wrongful dealing in medicines, herbal medicines and allied substances ��Unauthorized change of premises ��Failure to comply with other legislation e.g. local authority licensing, health requirements that were part of the conditions of initial approval A formal and legislated appeal process must be conducted prior to cancellation of a licence Department of Health Guidance Notes for the Application of Import and Export Licences To avoid undue delay in the approvalof applications for import and export licences, applicants are requested to note the followings :- 1. An application for Import Licence Form 3 covering pharmaceutical product or substance for local sale

or distribution must be accompanied by a copy of the Certificate ofRegistration or Certificate for

Clinical Trial/Medicinal Test of the product to be imported.

2. If the applicant is not the holder of a registration certificate of theproduct to be imported, the

application must be supported by a written authorization from the relevant product registration

certificate holder.

3. Full details concerning the products to be imported or exported such as description, quantity,

literature, medicinal/therapeutic uses, product insert, etc should be provided. If the product is registered

in Hong Kong, please state the Hong Kong Registration Number on the Import/Export Licence.

4. Applicant’s signature and company’s chop should be given on the application.

5. The Import Licence Form 3 should be completed in quadruplicate (original, duplicate, triplicate and

copy) and Export Licence Form 6 in triplicate (original, duplicate and triplicate).

6. If the applicant is holder of Antibiotics Permit, Wholesale Poisons Licence, Certificate of Registration

as an Importer and Exporter, Manufacturer’s Licence, Wholesale Dealer’s Licence to supply Dangerous

Drugs or Licence to manufacture Preparations of Dangerous Drugs, a copy of the relevant valid licence

or permit should accompany the application for the import or export licence.

7. If the product or substance to be imported is:

(a) for the purpose of clinical trial or medicinal test; or

(b) for the purpose of treatment by a registered medical practitioner or a registered dentist, of a

particular patient or, for the purpose of treatment by a registeredveterinary surgeon of a particular

animal; or

(c) by a pharmaceutical manufacturer for the purpose of manufacture or thecompounding of

pharmaceutical preparations, or

(d) for the purpose of application for registration of the substance, it should be clearly stated on the

Import Licence Form 3.

These notes are only a general guide and must not be treated as a complete or authoritative statement of the law on any particular case. Please refer to the Pharmacy and Poisons Ordinance and Import and Export Ordinance for the relevant legal provisions. Drug Registration and Import/Export Control Division September 2011 GUIDELINES FOR THE EXPORT OF DRUG ISSUED BY MINISTR Y OF HEALTH AND FAMILY WELFARE Subject: - Clarification about issuing NOCs for manufacture of new {Unapproved} drug solely for export. With reference to the above subject,

1. The application shall provide copy of valid export order and NOC will be issued. 2. The applicant shall identify the premision where the drug will be manufactured for export. 3. The applicant should mention whether the batch to be exported has undergone Quality control testing or shall be tested at the destined site. 4. The applicant shall ensure that the drug(s) manufactured on the basis of ―NOC given as per (1) above its exported and that no part of it is diverted for domestic sale in India. 5. The applicant shall ensure physical destruction of all unexported quantity of drugs. This should be included as a condition of manufacturing license issued to the applicant by the State licensing authority 6. The applicant shall make available for inspection of the appropriate authorities, on completion of the export orders, information regarding each consignment despatched, remaining stock of drug and related raw materials and intermediates in hand. . 7. The applicant shall ensure that the drug for which NOC has been given shall cease to be manufactured or exported if the drug is prohibited in future in the country or in the importing country. It is requested that immediate action may be taken to operationalise the process and a report on action taken in this regard to clear the pending applications may be sent to this office by 22.3.99. A monthly agreement may hereafter be sent of the NOCs issued by DCG(I) in an appropriate format.

RULES RELATED TO EXPORT OF DRUGS FROM INDIA Rule 94 :

Labelling And Packing Of Drugs Other Than Homoeopathic Medicines :

• Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported

• but the following particulars shall appear in a front position on the innermost container in which the drug is packed and every other covering in which that container is packed:

• (a) name of the drug; • (b) the name, address of the manufacturer and the number of the licence under which the drug

has been manufactured • (c) batch or lot number; • (d) date of expiry, • if any: [drug, not classified under Schedule F, Schedule F(1) and Schedule X, blood products,

Narcotic and Psychotropic Substances is required by the consignee (exporter) to be not labelled with the name and address of the manufacturer,

• (e)the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in Rule

• The provisions of Rules 96 to 101 inclusive, shall not apply to a medicine made up ready for treatment, whether after or without dilution, which is supplied on the prescription of a registered practitioner provided that:

• The medicine is labelled with the following particulars: – • (a) The name and address of the supplier; • (b) The name of the patient and the quantity of the medicine; • (c) The number representing serial number of the entry in the prescription register; • (d) The dose, if the medicine is for internal use; • [(e) The words ―FOR EXTERNEL USE ONLYǁ shall be printed on the label if the medicine is

for external application].