Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Uganda: what a foreign sponsor needs
Uganda's medicines authority is NDA, the National Drug Authority. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Uganda
Authority: NDA · National Drug 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 harmonisation arrangements.
Reliance / regional
Regional harmonisation routes available for eligible products.
Language and dossier
English.
Watch out for
Harmonisation eligibility must be confirmed before sequencing the filing.
Indicative. Confirmed per product as part of an assessment.
Scope Uganda →Questions about Uganda
Can a foreign company hold its own product registration in Uganda?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and NDA needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Uganda?
National submission. Participates in regional harmonisation arrangements.
Are reliance or regional routes available in Uganda?
Regional harmonisation routes available for eligible products.
What language must the dossier be in for Uganda?
English.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRANamibiaNMRCGhanaFDA GhanaMozambiqueANARMECôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
NDA 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.