Health Legislation

The purpose of this ordinance is to determine the rates and fees for regulatory services offered on drugs and other health products by the drug regulatory authority for Burundi (ABREMA).

This Decree approves the amended statutes of the Beninese pharmaceutical regulatory agency, now named “Beninese Agency for Medicines and other Health Products”.

This order establishes the essential medicines list; this list is revised every three years (article 10).

The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.

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.

This Decree establishes and fixes the rules of organization and operation of the Senegalese Pharmaceutical Regulatory Agency (ARP)

The decree provides the modalities for establishing the list of essential medicines. It was published in the Official Journal of 31 May 2021 (pages 12 -13).

The Decree approves the National List of Essential Medicines. 

This decree determines the conditions for the creation, approval, operation and control of reproductive health structures in application of the provisions of Article 12 paragraph 3 of Law No. 2003-04 of March 3, 2003 relating to the sexual and reproductive health.

The law creates the Burundian Authority for the Regulation of Medicines for Human Use and Food. The authority's general aim is to protect public health by promoting the quality and safety of products such as prefabricated and ambient foods, medicines for human use, cosmetics and dietary products containing active ingredients, herbal medicines, traditional medicines, and medical devices, among others.

The decree provides for the organization and functioning of the Central Purchasing Center for Essential Medicines of Burundi [CAMEBU].

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 Regulation sets up rules in the registration of drugs and related products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria.  

The order of 11 Joumada El Oula 1442 corresponding to 26 December 2020 lays down the procedure for setting the prices of medicinal products by the intersectoral economic committee for medicinal products. The text of this order was published in the official journal of 27 December 2020 (see pages 33-36).

The order establishes the national list of essential medicines and other health products in Burkina Faso.

The Decree approves the Organic Statute of the Autoridade Nacional Reguladora de Medicamento (The National Medicines Regulatory Authority). The purpose of this Decree is to define the rules governing the organization, management and operation, as well as the powers of its bodies.

These Regulations provide rules on the registration and access to the market to medicine; licensing requirements for pharmaceutical operations, manufacturers, wholesalers and dispensaries; as well as on record-keeping, import of medicines, and clinical trials, etc.

The Decree establishes free access to family planning care and services in Burkina Faso (art.1). These are provided in public health facilities by community health workers (art.2). Private facilities can choose to implement the same, but need to sign an agreement with the Ministry of Health to settle the conditions and modalities (art.3). Specific services covered are to be determined by a joint order from the Ministers responsible for Health and Finances (art.4). These measures are financed by the budget of the State and partners (art. 5) and will be realized progressively (art. 6).

The document establishes the list of essential medicines in the Republic of Mali.