Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Côte d'Ivoire: what a foreign sponsor needs
Côte d'Ivoire's medicines authority is AIRP, the Autorité Ivoirienne de Régulation Pharmaceutique. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Côte d'Ivoire
Authority: AIRP · Autorité Ivoirienne de Régulation Pharmaceutique
Local responsible entity
Required
Accountable in-market party
Local safety contact
Required
Contactable point for the authority
Clinical trial route
National submission. Language requirements affect preparation time.
Reliance / regional
Confirmed per product.
Language and dossier
French. Francophone dossier requirements apply.
Watch out for
Francophone regulatory capacity is scarce and is the usual scheduling constraint.
Indicative. Confirmed per product as part of an assessment.
Scope Côte d'Ivoire →Questions about Côte d'Ivoire
Can a foreign company hold its own product registration in Côte d'Ivoire?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and AIRP needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Côte d'Ivoire?
National submission. Language requirements affect preparation time.
Are reliance or regional routes available in Côte d'Ivoire?
Confirmed per product.
What language must the dossier be in for Côte d'Ivoire?
French. Francophone dossier requirements apply.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRANamibiaNMRCGhanaFDA GhanaUgandaNDAMozambiqueANARME
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
AIRP 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.