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