Drug export rule trims gatt sadc wto

1. 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

2. 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.

3. 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

4. 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

5. 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.

6. 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)

7. 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):

8. • 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;

9. 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

10. 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.

11. 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

12. 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

13. 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

14. 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.

15. 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.

16. 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.

17. 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 MINISTRY
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,

18. 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

19. • 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].