Principles and Practice of Pharmaceutical Medicine

Approval of quality control laboratories.

Review of technical and post-marketing surveil-
lance reports.

Responsible for the program of bioequivalence
studies as a part of quality assurance.

The aim of the GCC-DR is to harmonize company
and product registrations between the member
states.
Applications to the GCC-DR for company regis-
tration (original plus six copies) must include the
following:

Application Form

GMP certificate (needs legalization, preferably
from Saudi Arabian Embassy, but the other
member states are also accepted)

Manufacturing license

Product information table

Research summary

In case of subsidiaries, certificates issued by the
parent company

Confirmation of payment of fee

After a positive evaluation, the company must
prepare for the three-person inspection from the
authority.
Documents which have to be submitted for the
GCC-DR Product registration (original plus six
copies) include the following:

Application Form

Certificate of Pharmaceutical Product (CPP)

Dossier

Fifteen finished product samples (with CoA)

Fifteen samples of packaging material (labeling

needs health authority approval, leaflet should be

in Arabic and/or English)

Animal source information, percentage of alco-

hol (if applicable)

List, in which countries the product is registered

Confirmation of payment of fee

The GCC-DR review of the dossier

At the first stage, two member states make a

review and compile an evaluation report, which is

then reviewed by the committee. Afterwards, the

preliminary technical and pricing approval

follows.

The second stage includes the laboratory analy-

sis (only performed in Saudi Arabia, Kuwait or

UAE). Then, a GCC-DR registration certificate is

issued. Thereafter, each member state issues its

own national license, usually after receiving pay-

ment of fees.

References

Auswaertiges Amt, Deutschland (July 2004), http://www.

auswaertiges-amt.de.

Deutsche Gesellschaft fu ̈r Regulatorische Angelegen-

heiten e.V. (2003)

Executive Board of the Health Ministers’ Council for

GCC States, (2004), http://www.sgh.org.sa.

RAJ August 2001, Sabih R Kukhun, Registration in

Saudi Arabia, p 645 ff

RAJ September 2000, Taha Gihan, Registration of

medicinal Products in Egypt, p 318 ff

WHO statistics, GDP data from 2001, 30.07.2004.

Wikipedia, freie Enzyklopa ̈die, (2004), http://www.de.

wikipedia.org.

REFERENCES 515