Gulf (GCC) country registration and Export procedure

1. REGULATORY REQUIREMENT AND REGISTRATION OF INDIAN
DRUG PRODUCTS IN GULF (GCC) COUNTRIES
PRESENTED BY : DONEE
ISF COLLEGE OF PHARMACY, MOGA
Email- doneegaeg1609@gmail.com

2. Content
 Introduction
 Drug Registration Procedure in Gulf Country
Centralized registration procedure
Decentralized registration procedure
 Regulatory Requirement For Drug
Products Registration in Gulf Countries
 Export Procedure

3. Introduction
 The Gulf Cooperation Council (GCC) was established by an agreement concluded
on 25 May 1981 in Riyadh. The Gulf Cooperation Council consist of six countries
Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and UAE because of their special
relations, similar political systems based on Islamic beliefs, joint destiny, and
common objectives. The official language is Arabic. Due to rapid population
expansion, rising life expectancy, and an increase in the prevalence of non-
communicable diseases (NCDs), these countries today face a greater need for
health care services .
 The GCC nations continue to import 80% of the medications they require from
significant global corporations. By 2020, the GCC nations should be able to invest
up to $12 billion in the production of pharmaceuticals.
 During 2020-21, total pharma export in USD 24.35 billion.
 Vision 2030 that was recently launched in Saudi Arabia is a great motive to
advance and invites foreign investors in all aspects of the industry including
Pharmaceuticals.

4. Drug Registration in Gulf Country
Drug registration: there are two processes of drug registration:
 Centralized registration procedure
 Decentralized registration procedure

5. Centralized Registration Procedure
 The executive office of GCC-DR assumes the receipt of registration
files after ensuring the fulfillment of registration requirements and upon
duly filling the following forms:
• The drug companies’ registration form.
• A pharmaceutical chemical entity/ preparation registration form.
 Eight complete files for each chemical entity and 17 samples have to be
submitted to the executive office and two samples shall be dispatched
to each country along with registration file.
 Every country shall study the registration files forwarded to it and then
return those files with its recommendation to the committee.
 The company needs to provide the laboratory for the analysis of
standard materials, methods etc.
 The executive office dispatches the samples of chemical entity to
reference-accredited laboratory for the analysis.

6.  After approving the registration of company and or chemical entity centrally, the
remaining authentication and documentation, fees are finalized on country basis.
 The executive office issues the registration certificate.
Decentralized registration procedure
 Registration regulations in major countries of GCC
 Although there is a centralized and quite harmonized process for drug
registration in GCC countries, the regulatory requirements of a few big
countries like Saudi Arabia and UAE are separate. These countries have their
well-established regulatory system and its enforcement.

7. Regulatory Requirement For Drug
Products Registration in Gulf Countries
The necessary regulatory requirement for the registration of drug product in
UAE, Saudi Arabia, Bahrain, Kuwait and Oman are:
 Site Registration
 Plant GMP Approval
 Stability Zone and requirement
 No. of Submission of Batches
 Dossier Format
 Registration Time
 Free Sale Certificate
 Price Certificate
 Labeling
 BA/BE Study

8. Export Procedure

9. Thank You