NIGER
NIGER
Niger is a country in West Africa having French as its official language. The capital is Niamey.
Niger is a member state of the Economic Community of West African States (ECOWAS).
Medicines can be imported to Niger only after registration.
Medicines market in Niger:
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. Niger has only one manufacturing unit.
Registration of medicines:
Niger 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: Nigerien Regulatory Agency for the Pharmaceutical Sector (ANRP) https://www.dphmt-msp.ne/
The registration of medicine depends on the level of compliance of the file and requires 9 to 18 months.
Registration of medical devices:
Niger 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: Nigerien Regulatory Agency for the Pharmaceutical Sector (ANRP) https://www.dphmt-msp.ne/
AREMA offers you total assistance for the registration of your medicines and medical devices in Niger.
We provide regulatory services from feasibility study, regulatory intelligence, preparation and translation of your dossier, deposit, follow-up and registration of your 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: