BENIN
BENIN
The Republic of Benin is a state in West Africa. Benin has approximately 13 million inhabitants. Benin has French as its official language and the CFA franc as its currency.
Benin is a member state of ECOWAS.
No medicine can be marketed in Benin without having received a marketing authorization (MA).
Medicines market in Benin:
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. Benin only produces 2% of its medicine needs.
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.
Registration of medications:
The state of Benin is a member of regional institutions, mainly the West African Economic and Monetary Union (WAEMU) and therefore applies its guidelines on the registration of medicines. In addition, there are some national texts and specificities of the country to know.
The registration file must be in CTD format and in French.
The authority responsible for the registration of medicines is, since 2019, the Beninese Agency for Pharmaceutical Regulation (ABRP), whose website: https://www.abrp.bj/
The registration of medicines depends on the level of compliance of the file.
AREMA offers you total assistance for the registration of your medicines in Benin.
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.
In order to initiate any collaboration or for any consultation you can contact us by email: