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 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.

This document provides the national list of essential medicines and other health products in Ethiopia. 

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.

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 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.  

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.

This Proclamation regulates activities in respect of food, medicine, environmental health, health professionals, health and controllable health related institutions in the country.

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.