Agence Béninoise de Régulation et d'Enregistrement des Produits (ABREP)

 

The Agency is established to create and sustain a Regulatory Center of Excellence within UEMOA.

 

ABREP’s Mission

ABREP exists as an integral part of the Ministry of Health Benin to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco, household equipment and the conduct of clinical trials in the country.

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ABREP’s Quality Policy

ABREP will continually ensure quality, safe and efficacious / effective / wholesome products through Registration, Inspections, Licensing, Surveillance and Clinical Trials activities in conformity with the applicable national and international standards and to meet public satisfaction.

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ABREP is the National Regulatory Body responsible for the regulation of food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products and the conduct of clinical trials protocols.

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ABREP was established in 2019 by the National Parliament of Benin under the revised Regulatory Products Legislation of December 2018 and integrated into a new Public Health Law 851, 2018 that gave birth to ABREP.

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ABREP legal mandate is found in part 6 (Tobacco Control Measures), part 7 (organization and responsibilities of the FDA), and part 8 (Clinical trials) of the Public Health Law, 2018 Section 851.

The Public Health Law, 2018 provides for the establishment of a governing board with the responsibility of ensuring the effective implementation of the functions of the Agency.

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ABREP currently has eleven-member Management Board. Administratively, the Agency is headed by the Director General who reports directly to the Management Board. The Chief Executive Officer of the ABREP takes responsibility for the daily operational management, service delivery and strategic issues of the Agency.

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ABREP has four (4) technical advisory committees (TAC) for safety of medicines, safety of vaccines and biological products, medical devices and clinical trials. The committees are made up of experts from different scientific backgrounds. The TAC on safety was formed to act as a forum to advise the Agency on matters relating to post-approval safety, efficacy, and effectiveness of the products granted marketing authorization by the Agency. The TAC for clinical trials also advises the ABREP on matters related to the conduct of clinical trials. The TAC provides expertise to assist the Agency in making appropriate risk management decisions, however, the decision making responsibility remains with the ABREP

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Functions of the Agency:

a. Ensure adequate and effective standards for food, drugs, cosmetics, household chemicals , medical devices, Sanitary wares etc.;

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b. Monitor through the District Assemblies and any other agency of State compliance with the provisions of Part 6,7 and 8 of the Public Health Law ,2018 (Section 851);

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c. Advise the Minister on measures for the protection of the health of consumers;

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d. Advise the Minister on the preparation of effective Regulations for the implementation of Part 6,7 and 8 of the Public Health Law, 2018 (Section 851);

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e. Approve the initiation and conduct of clinical trials in the country;

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f. Perform any other functions that are ancillary to attaining the objects of the Agency (such as checking to prevent any possible manipulation of registered / unregistered products by Importers / Exporters).

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