Regulatory Affairs

The medicine, after its first production, follows a long path, before arriving, at the patient’s disposal, in the pharmacy.

Our regulatory department counts some specialists, in charge of registering and renewing the marketing authorizations in our countries of distribution, for the manufacturer laboratory.

Each country has its particular requirement. We make sure that we meet each demand, in accordance with UEMOA (Union Economique et Monétaire Ouest-Africaine), CEMAC (Communauté Economique et Monétaire de l’Afrique Centrale) or each Health Ministry.

Taking into account all the requirements, we create registering or renewing files. The manufacturer  laboratory provides us the elements needed for the pharmaceutical file (final product, AMM file, original and legalized documents, etc…)

Then, we send our demand to the Health Ministry in Africa.

Locally, the Country Manager follows the evolution of the files, close to their special spokespersons in Health Ministry. They tell us about the obtained visas and the special requirements.