Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Zimbabwe: what a foreign sponsor needs
Zimbabwe's medicines authority is MCAZ, the Medicines Control Authority of Zimbabwe. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Zimbabwe
Authority: MCAZ · Medicines Control Authority of Zimbabwe
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
Clustering with neighbouring markets usually determines whether entry is economic.
Indicative. Confirmed per product as part of an assessment.
Scope Zimbabwe →Questions about Zimbabwe
Can a foreign company hold its own product registration in Zimbabwe?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and MCAZ needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Zimbabwe?
National submission with regional work-sharing routes.
Are reliance or regional routes available in Zimbabwe?
Regional work-sharing available for eligible products.
What language must the dossier be in for Zimbabwe?
English.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZambiaZAMRANamibiaNMRCGhanaFDA GhanaUgandaNDAMozambiqueANARMECôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
MCAZ 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.