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.

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.

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 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.

This Proclamation is to provide for Food and Medicine Administration. It provides rules to regulate several areas including food, medicine, medical devices, cosmetics, and tobacco products.

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.

These regulations establish the Health Professionals Council. The council has, among other things, the following attributions: advise the Minister; work in collaboration with the appropriate bodies, ensure that health professional training offered in the country is of high standard; make sure that professional ethics are observed by professionals; follow up and supervise that the names of registered professionals and those who are cancelled from the registry due to various reasons are properly kept by the secretariat.