Gabon
Gabon
Gabon, in long form the Gabonese Republic, is a country located in Central Africa with French as its official language. The capital is Libreville.
Gabon is a member state of the Economic Community of Central African States (ECCAS).
Medicines and medical devices can only be imported into Gabon after registration.
Medicines market in Gabon:
The African market in general is a high-volume import market, in Africa local production accounts for only 3% of world production, while the market is expanding, and demand is growing. Gabon has only one manufacturing unit.
Moreover, introduction of noncommunicable diseases in addition to the major pandemics on the continent, did that the demand for medicines has never been so strong.
Drug registration:
Gabon has its own national texts concerning the registration of medicines.
The registration file must be in CTD format and in French.
The authority governing the registration of medicines: Gabon Medicines Agency https://www.amgabon.ga/index.php
The registration of medicines depends on the level of compliance of the file and requires 12 to 24 months.
Medical devices:
Gabon has its own national texts also concerning the registration of medical devices.
The authority governing the registration of medicines: Gabon Medicines Agency https://www.amgabon.ga/index.php
The registration of medical devices depends on the level of compliance of the file and requires 12 to 24 months.
AREMA offers you total assistance for the registration of your medicines and medical devices in Gabon.
We provide regulatory services from the regulatory intelligence, preparation and translation of your dossier, the deposit, follow-up, and registration of your various products until the establishment of a system of pharmacovigilance and post-marketing monitoring.
To initiate any collaboration or for any consultation you can contact us by email: