Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Namibia: what a foreign sponsor needs
Namibia's medicines authority is NMRC, the Namibia Medicines Regulatory Council. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Namibia
Authority: NMRC · Namibia Medicines Regulatory Council
Local responsible entity
Required
Accountable in-market party
Local safety contact
Required
Contactable point for the authority
Clinical trial route
National submission with regional work-sharing routes.
Reliance / regional
Regional work-sharing available for eligible products.
Language and dossier
English.
Watch out for
Small market: viable mainly as part of a sequenced regional cluster.
Indicative. Confirmed per product as part of an assessment.
Scope Namibia →Questions about Namibia
Can a foreign company hold its own product registration in Namibia?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and NMRC needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Namibia?
National submission with regional work-sharing routes.
Are reliance or regional routes available in Namibia?
Regional work-sharing available for eligible products.
What language must the dossier be in for Namibia?
English.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRAGhanaFDA GhanaUgandaNDAMozambiqueANARMECôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
NMRC 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.