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Ordonnance ministérielle conjointe 630-540-134 du 29 01 2024 portant fixation des tarifs et redevances pour les services offerts sur les médicaments et les autres produits de santé par l’ABREMA
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).
Ordonnance ministerielle 630-991 portant révision de l'ordonnance ministerielle 630/450/750 portant mode et conditions d'homologation des médicaments à usage humain et autresintrants pharmaceutiques au Burundi
The purpose of this ordinance is to organize the registration of medicines for human use and other pharmaceutical inputs in Burundi.
Décret No 100/039 du 26 février 2021 portant création, organisation et fonctionnement de l'Autorité burundaise de régulation des médicaments a usage humain et des aliments, "ABREMA" en single
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.
Décret No 100/156 du 30 juin 2021 portant organisation et fonctionnement de la Centrale d'Achat des médicaments essentiels, des dispositifs médicaux et produits et matériels de laboratoire du Burundi "CAMEBU"
The decree provides for the organization and functioning of the Central Purchasing Center for Essential Medicines of Burundi [CAMEBU].
Loi No 1/11 du 08 mai 2020 portant réglementation de l'exercice de la pharmacie et du médicament a usage humain
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.
South Sudan Essential Medicines List (SSEML)
The South Sudan Essential Medicines List (SSEML) is a comprehensive list of medications essential for addressing the country's public health needs, prioritizing safe, effective, and affordable treatments for the most common health conditions.
Drug and Food Control Authority Act, No 37
This Act provides for the establishment of an independent Drug and Food Control Authority in South Sudan and provide an appropriate and effective independent regulatory mechanism to control and regulate the manufacture, supply, promotion, marketing, advertising, distribution and use of drugs, poisons, chemicals, cosmetics medical devices and food for human or animal use.