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).
The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
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 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 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 legislation regulates the production, import, export, conservation, distribution, quality analysis and sale of medicines for human use, including traditional medicines, as well as all other health products, pharmaceutical practice and opticianry.