The Decree sets out the statutes of the Nigerian Pharmaceutical Regulatory Agency.
Décret No 2021-279/PRN/MSP/O/AS du 29 avril 2021, adoptant la Politique Pharmaceutique Nationale
The Decree adopts the national pharmaceutical policy. This policy sets out and prioritizes the medium- and long-term goals set by the State for the pharmaceutical sector, and defines the main strategies for achieving them. It provides a framework within which pharmaceutical sector activities are coordinated. It covers both the public and private sectors, and involves all the main players in the pharmaceutical sector. It is an integral part of national health policy.
The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.
Arrêté No 110 MSP/SG/DGSP/MT portant révision de la Liste Nationale des Médicaments Essentiels
The decree revises Niger's national list of essential medicines.
The decree creates a multi-sectoral committee to combat counterfeiting and the illicit sale of medicines and other pharmaceutical products, reporting to Niger's Minister of Public Health.
The decree establishes a Committee of Experts in charge of technical evaluation, whose mission is to carry out the technical evaluation of applications for registration of pharmaceutical products for human use. It also gives an opinion on the quality, safety and efficacy of pharmaceutical products for human use submitted for registration.
The decree creates the Commission Nationale du Médicament (CNM) for human use, whose mission is to validate the work of the Expert Committee responsible for the technical evaluation of applications for marketing authorization for pharmaceutical products for human use. It also gives a final opinion on marketing authorization applications; applications for renewal, extension of variation and transfer of marketing authorization; temporary suspension of marketing authorization; and proposals for definitive withdrawal of marketing authorization.
The decree revises Niger's national list of essential medicines from 2009
The purpose of the Regulation is to define the procedures for approving pharmaceutical products for human use in the member states of the West African Economic and Monetary Union.
The Ordinance provides legislation governing pharmacy. The ordinance regulates the classification of medicines, the registration of medicines, the dispensing of medicines, dietary products, cosmetics, the rules for practicing the profession of pharmacist, the dispensing of medicines by doctors and other aspects.