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 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 Constitution was promulgated by Decree No 2010-754 of 25 November 2010. It includes 185 articles addressing a wide array of issues including, among other things, human rights and duties and institutional arrangements.

This ordinance establishes a General Code of Local Authorities in the Republic of Niger. The General Code of Local Authorities sets out the fundamental principles of the free administration of local authorities, their powers and their resources. It establishes the legal framework for their management.

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 Constitution of Niger (2010) is structured into several titles, each addressing different aspects of the state's governance and the rights of its citizens. The document begins with a Preamble, followed by Title I: The State and Sovereignty, which outlines the fundamental principles of the Republic of Niger. Title II: Rights and Duties of the Human Person includes various articles on individual rights, including health rights. Title III: Executive Power details the roles and responsibilities of the President and the Government. Title IV: Legislative Power focuses on the functions of the National Assembly. Title V: Relations Between Executive and Legislative Powers describes the interaction between these branches. Title VI: Judicial Power covers the judiciary's independence and structure. Title VII: Economic, Social, and Cultural Development outlines the state's development policies. Title VIII: The Higher Council of Communication addresses media and communication regulations. Title IX: Local Authorities discusses decentralization and local governance. Title X: Treaties and International Agreements covers the process of treaty ratification. Title XI: Cooperation and Association with States focuses on international cooperation. Title XII: Revision details the process for amending the Constitution. Title XIII: Transitional Provisions and Title XIV: Final Provisions conclude the document. Articles 12 and 13 specifically refer to health rights. Article 12 states that everyone has the right to health, and Article 13 emphasizes the state's duty to create conditions ensuring access to medical services and assistance in case of illness.

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 decree creates a technical-administrative division known as a health district for towns, departments, arrondissements and communes. The Health District is the local level for the design, planning, implementation, monitoring and evaluation of health policy.

The order M°154/MSP/CAB of 29 December 1994 provides the structure and mandate for the Departmental Directorate for Health ("Direction Departementale de la Santé"); this directorate represents the Ministry of Public Health at the level of the department or the urban community and participates in the elaboration, implementation and evaluation of the National Health policy ( providing the competence of the Department Direction for Health). The subdivisions of this directorate include an Executive Secretariat; an Administrative, Financial and Personnel Management Department; a Family Health Service; a Programming and Health Information Department; a Health Education, Hygiene and Sanitation Department; a Health Education, Hygiene and Sanitation Department; a Pharmacy and Laboratory Department.