Health Legislation

The Decree sets out the statutes of the Nigerian Pharmaceutical Regulatory Agency.

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.

The decree creates a National Technical Committee responsible for the administration of the District Health Information System in Niger. Its mission is to ensure the administration and updating of the platform; to identify and deal with users' technical grievances and concerns, and to ensure the system's security, maintenance and capacity building.

The purpose of the law is to determine the legal regime of civil status in Niger. It institutes a civil status system, which is the set of qualities inherent to a person that the law takes into consideration in order to attach legal effects to that person. The law governs declarations of civil status facts.

The decree revises Niger's national list of essential medicines.

The purpose of the law is to govern the protection of personal data.

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 order creates a framework for reflection and exchange between players and partners in the implementation of health research, called the "Cadre de Concertation de la Recherche en Santé" (Health Research Consultation Framework), reporting to the Minister in charge of Public Health. Its mission is to promote exchanges and build the capacities of players involved in health research.

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.

The law determines which individuals have Nigerien nationality at birth as their nationality of origin. Nigerien nationality is acquired or lost, after birth, by the effect of the present legislation or by decision of the public authority taken under the conditions laid down in this law.