Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Nigeria: what a foreign sponsor needs
Nigeria's medicines authority is NAFDAC, the National Agency for Food and Drug Administration and Control. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Nigeria
Authority: NAFDAC · National Agency for Food and Drug Administration and Control
Local responsible entity
Required
Accountable in-market party
Local safety contact
Required
Contactable point for the authority
Clinical trial route
National submission. Route and timeline confirmed per product class.
Reliance / regional
Confirmed per product.
Language and dossier
English. CTD format.
Watch out for
Local representative arrangements and import documentation are the usual friction points.
Indicative. Requirements and timelines are confirmed against current published guidance per product.
Scope Nigeria →Questions about Nigeria
Can a foreign company hold its own product registration in Nigeria?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and NAFDAC needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Nigeria?
National submission. Route and timeline confirmed per product class.
Are reliance or regional routes available in Nigeria?
Confirmed per product.
What language must the dossier be in for Nigeria?
English. CTD format.
Other markets
South AfricaSAHPRAKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRANamibiaNMRCGhanaFDA GhanaUgandaNDAMozambiqueANARMECôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
NAFDAC and ethics submissions, site activation, import permits, local safety contact.
Registration
Dossier lodgement, route selection, sameness and bridging, variations and renewals.
Local representation
MAH and Local Technical Representative coordination with licensed local partners.