MALI
MALI
The Republic of Mali is a state in West Africa. Its capital is Bamako and French is the official language, but the population mainly speaks the national languages, Bambara.
Mali is a member state of the Economic Community of West African States (ECOWAS).
Medicines can be imported to Mali only after registration.
Medicines market in Mali:
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. Mali has two 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.
Registration of medicines:
Mali is a member of regional institutions, mainly 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 dossier must be in CTD format and in French language.
The authority governing the registration of medicines: Directorate of Pharmacy and Medicines (Ministry of Health)
The registration of medicine depends on the level of compliance of the file and requires 9 to 18 months.
Registration of medical devices:
Mali also applies the WAEMU directives concerning the registration of medical devices. In practice this could be different and an evaluation on a case-by-case basis is necessary before initiating projects.
The authority governing the registration of medical devices: Directorate of Pharmacy and Medicines (Ministry of Health)
AREMA offers you total assistance for the registration of your medicines and medical devices in Mali.
We provide regulatory services from feasibility study, 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: