Locally incorporated applicant
Required
Dossier lodged by a local legal entity
Registering a medicine in Mozambique: what a foreign sponsor needs
Mozambique's medicines authority is ANARME, the Autoridade Nacional Reguladora de Medicamentos. A foreign manufacturer cannot hold its own registration. These are the local positions the law requires, and the routes available.
Mozambique
Authority: ANARME · Autoridade Nacional Reguladora de Medicamentos
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
Portuguese. Translation and localisation are on the critical path.
Watch out for
Translation and localisation effort is routinely underestimated in planning.
Indicative. Confirmed per product as part of an assessment.
Scope Mozambique →Questions about Mozambique
Can a foreign company hold its own product registration in Mozambique?
No. The dossier must be lodged by a locally incorporated applicant, the product needs a local responsible entity, and ANARME needs a locally contactable safety point. These are statutory requirements.
What is the clinical trial route in Mozambique?
National submission. Language requirements affect preparation time.
Are reliance or regional routes available in Mozambique?
Confirmed per product.
What language must the dossier be in for Mozambique?
Portuguese. Translation and localisation are on the critical path.
Other markets
South AfricaSAHPRANigeriaNAFDACKenyaPPBTanzaniaTMDABotswanaBoMRAZimbabweMCAZZambiaZAMRANamibiaNMRCGhanaFDA GhanaUgandaNDACôte d'IvoireAIRP
Compare all twelve side by side on the markets page, or read the AMA Continental Listing guide.
Clinical trials
ANARME 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.