Health Legislation

This regulation is issued to implement the Food and Medicine Administration Proclamation No.1112/2019. It provides the organization, powers and duties of the Ethiopian Food and Drug Authority.

This regulation is issued to implement Proclamation No. 1273/2022 Community-Based Health Insurance Proclamation. It establishes the framework for managing health insurance pools and reserve funds (Sections 3-6), outlines membership and contribution procedures (Sections 7-9), and details provider payment mechanisms (Section 10). It also addresses fund management, financial deficit coverage (Sections 11-13), and miscellaneous provisions such as co-payment and data management (Sections 14-20).

The decree creates the National Institute for Medical Assistance ("Institut National d'Assistance Médicale"), which is placed under the supervision of the Ministry of Public Health and the financial supervision of the Ministry of Finance. The Institute's main mission is to implement policies, strategies and reforms relating to the financing and delegated management of free health care for Niger's vulnerable populations by the State and local authorities.

The Order adopts the statutes of the National Institute for Medical Assistance ("Institut National d'Assistance Médicale"), which has as its main mission the implementation of policies, strategies and reforms relating to the financing and delegated management of free healthcare by the State and local authorities for the benefit of vulnerable populations in Niger.

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

The Decree adopts the National Strategy for University Health Coverage in Niger 2021-2030.

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.

This decree establishes the National Institute for Medical Assistance (Institut National d'Assistance Médicale) whose mission is to implement the policies, strategies an reforms for finanicng and managing free healthcare services for vulnerable populations. It is under the ministry of health (technical supervision) and the Ministry of Finances (financial suppervision). The decree further addresses the mandate, structure and ressources of the Institute.

The Decree sets out the terms of application of Law No. 2018-22 of April 27, 2018, determining the fundamental principles of Social Protection.

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 decree revises Niger's national list of essential medicines.

This Regulation is to determine the fee payable for registration and license of food, medicine, health professional and health institutions.

This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.  

This decree establishes the criteria and the modalities to prove indigent status during a judicial process

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 Proclamation establishes a mandatory health insurance scheme for pensioners, employees and members of their families in Ethiopia.

The decree revises Niger's national list of essential medicines from 2009