Ministère de l'enregistrement des produits et de l'autorisation du commerce du Bénin
Aux fins de protection de la santé publique
About Ministère de l’enregistrement des produits et de l’autorisation du commerce du Bénin (MOHBENIN)
The Ministère de l’enregistrement des produits et de l’autorisation du commerce du Bénin (MOHBENIN) was established to foster and maintain a center of regulatory excellence within the West African Economic and Monetary Union (UEMOA).
Mission
As an integral component of the Ministry of Health of the Republic of Benin, MOHBENIN is dedicated to protecting public health by ensuring the safety, efficacy, and security of human and veterinary medicines, food products, biologicals, cosmetics, medical devices, household chemical substances, tobacco products, and related items, as well as overseeing the conduct of clinical trials within the country.
Quality Policy
MOHBENIN commits to continuously delivering high-quality, safe, effective, and wholesome products through comprehensive activities in registration, inspections, licensing, post-market surveillance, and clinical trial oversight. These efforts align with applicable national and international standards to achieve public satisfaction.
Mandate and Responsibilities
MOHBENIN serves as the national regulatory authority responsible for overseeing food products, pharmaceuticals, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, as well as clinical trial protocols.
Established in 2021 under revised regulatory legislation, MOHBENIN operates in accordance with relevant national decrees and public health frameworks.
Its legal mandate encompasses tobacco control measures, organizational responsibilities for product regulation, and the oversight of clinical trials. A governing board ensures the effective execution of the agency’s functions.
MOHBENIN is governed by an eleven-member Management Board. Administratively, it is led by the Director-General, who reports directly to the Board. The Chief Executive Officer assumes responsibility for day-to-day operations, service delivery, and strategic direction.
The agency is supported by four technical advisory committees (TACs) focused on the safety of medicines, vaccines and biological products, medical devices, and clinical trials.
Composed of experts from diverse scientific disciplines, these committees provide advisory forums on post-approval safety, efficacy, effectiveness, and risk management for authorized products, as well as guidance on clinical trial conduct. While the TACs offer expert input to inform decisions, final regulatory authority rests with MOHBENIN.
Key Functions
- Establish and enforce adequate standards for food, pharmaceuticals, cosmetics, household chemicals, medical devices, sanitary wares, and related products;
- Monitor compliance with relevant provisions of public health legislation through collaboration with district assemblies and other state agencies;
- Advise the Minister of Health on consumer health protection measures;
- Provide recommendations to the Minister on the development of effective regulations for implementing public health laws;
- Approve the initiation and conduct of clinical trials in Benin;
- Undertake ancillary functions necessary to achieve the agency’s objectives, including measures to prevent manipulation of registered or unregistered products by importers or exporters.
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