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