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