Requirements for Re-registration of Pharmaceutical
Companies Centrally (Manufacturing Site)
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Fill up the application form for Re-registration of Manufacturer / Company
signed and stamped by the company that shows there is no changes in the
status of the company previously registered centrally since five years.
The type and the activity of the company.
The number and addresses for the factories that owned by the company.
Company’s relationship with each of these factories and it extent legally,
technically & commercially responsibility.
Certificate issued by regulatory authorities in the country of origin to prove
commitment to the foundations of good manufacturing practice (GMP) newly
issued by health authorities and certified.
Submit certified Manufacturing license issued by health authorities.
List of the products produced by the manufacturer by its name or account
which manufactured contractually or for other company, marketing and
registration in the country of origin or in other countries.
Prepare list of names of countries which the company registered with, and
attach the registration certificates.
Letter from the company confirms that the products to be exported
identically to the compositions and methods of manufacturing in the
market of country of origin.
Obligation commitment as mentioned in the guidelines of drug gulf
marketing.
Activity of the company in research and development.
Submit the Site Master File.
Submit the above requirements in hardcopy & softcopy (DVD or CD format)
Payment of fees which prescribed by the executive office to renew the
registration.