Overview

of company registration requirements in the MENA region North Africa, Egypt, Lebanon and Iran North African countries, such as Egypt, Lebanon and Iran, do not require a separate company registration for the manufacturing site or the MAH. However, these MENA countries will still ask for key documents related to the manufacturing sites involved in the drug product manufacturing and batch release sites during the product registration procedure. Those documents will include:

  • Country specific application forms
  • Legalized manufacturing licenses
  • Legalized GMP certificates
  • List of products manufactured by the manufacturing site
  • Site Master File
  • R&D activities overview

Company part review will take place simultaneously with the product registration review with no impact on the overall registration procedure timelines.

GCC centralized procedure: company registration requirements

The Centralized Procedure through Gulf Central Committee for Drug Registration procedure (GCC-DR) will require a separate company registration and site inspection by Gulf auditors. The advantage of this registration and inspection is that it will be valid for the 7 Gulf states (Saudi Arabia, UAE, Kuwait, Oman, Qatar, Bahrain and Yemen). After obtaining the centralized approval, the applicant will still need to obtain a local registration approval certificate based on the submission of the centralized approval and local fees for company registration will still need to be paid. Below are the GCC company registration requirements. These are applicable for the MAH: Company Profile & Activities: a brief description of the company, the owners (in case of a private company), and the year it has been licensed. A number of manufacturing facilities owned by the company and the facilities' addresses. The company's relationship with all of the manufacturing sites and scope of legal and commercial responsibility (if applicable). Legalized Certificate proving the commercial relationship with one of the sub-distributors in the GCC states. Legalized GMP Certificate. Legalized Manufacturing License from the country of origin, mentioning the production lines. Organizational Chart, mentioning the different departments and the number of employees in each; Include the qualifications of the production managers, the person responsible for quality assurance, research and development manager, and the responsible pharmacist. Simplified Flowcharts of the different buildings and the production lines. List of products manufactured by the company for the products owned by the site and the products manufactured by contract manufacturing or under license, with the registration date and the marketing date in the country of origin and other countries. Letter from the company certifying that the products to be exported to GCC have the same composition as those marketed in the country of origin. List from the company indicating the countries where the company is registered and the copies of approval certificates. Undertaking a Letter from the company to commit to what is outlined in the Gulf medical marketing code. List of products the company intends to market in the GCC. Detailed Site Master File. The letter indicating the production lines the company wishes to register. The complete file for the first product the company wishes to register. Company Registration Form published on GCC-DR website

GCC centralized procedure: company registration requirements

The Centralized Procedure through Gulf Central Committee for Drug Registration procedure (GCC-DR) will require a separate company registration and site inspection by Gulf auditors. The advantage of this registration and inspection is that it will be valid for the 7 Gulf states (Saudi Arabia, UAE, Kuwait, Oman, Qatar, Bahrain and Yemen). After obtaining the centralized approval, the applicant will still need to obtain a local registration approval certificate based on the submission of the centralized approval and local fees for company registration will still need to be paid. Below are the GCC company registration requirements. These are applicable for the MAH:

  • Company Profile & Activities: a brief description of the company, the owners (in case of a private company), and the year it has been licensed.
  • A number of manufacturing facilities owned by the company and the facilities addresses.
  • The company's relationship with all of the manufacturing sites and scope of legal and commercial responsibility (if applicable).
  • Legalized Certificate proving the commercial relationship with one of the sub-distributors in the GCC states.
  • Legalized GMP Certificate.
  • Legalized Manufacturing License from the country of origin, mentioning the production lines.
  • Organizational Chart, mentioning the different departments and the number of employees in each; Include the qualifications of the production managers, the person responsible for quality assurance, research and development manager, and the responsible pharmacist.
  • Simplified Flowcharts of the different buildings and the production lines.
  • List of products manufactured by the company for the products owned by the site and the products manufactured by contract manufacturing or under license, with the registration date and the marketing date in the country of origin and other countries.
  • Letter from the company certifying that the products to be exported to GCC have the same composition as those marketed in the country of origin.
  • List from the company indicating the countries where the company is registered and the copies of approval certificates.
  • Undertaking a Letter from the company to commit to what is outlined in the Gulf medical marketing code.
  • List of products the company intends to market in the GCC.
  • Detailed Site Master File.
  • The letter indicating the production lines the company wishes to register.
  • The complete file for the first product the company wishes to register.
  • Company Registration Form published on GCC-DR website
 
     
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