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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).
Décret No 2023-327 portant modalités de mise en œuvre de l'assurance maladie obligatoire en république du Bénin
This decree defines the terms and conditions for implementing the mandatory health insurance.
Décret No 2023-422 portant approbation des status modifiés de l'Agence béninoise de Régulation pharmaceutique désormais dénommée Agence béninoise du Médicament et des autres produits de Santé
This Decree approves the amended statutes of the Beninese pharmaceutical regulatory agency, now named “Beninese Agency for Medicines and other Health Products”.
Arrêté N°2023-593 portant liste nationale des médicaments essentiels et autres produits de santé au Burkina Faso
This order establishes the essential medicines list; this list is revised every three years (article 10).
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.
Regulation No. 531/2023, Definition of Organization, Powers and Duties of the Ethiopian Food and Drug Authority
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.
Décret No 2023-034/PRN/MSP/P/AS du 12 janvier 2023 portant création d’un Etablissement Public à caractère administratif dénommé Institut National d’Assistance Médicale du Niger
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.
Décret No 2023-035/PRN/MSP/P/AS du 12 janvier 2023 portant approbation des statuts Institut National d’Assistance Médicale du Niger
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.
Décret No. 2023-097/PR confiant la gestion de l'assurance maladie universelle à l'institut national d'assurance maladie et à la Caisse nationale de sécurité sociale
This decree confers the management of Universal Health Insurance to the National Health Insurance Institute and the National Social Security Fund.
Décret No 2022-915/PRN/MSP/P/AS du 30 novembre 2022, portant approbation des statuts de l'Agence Nigérienne de Règlementation du secteur Pharmaceutique
The Decree sets out the statutes of the Nigerian Pharmaceutical Regulatory Agency.
Décret No 2022-824 portant création et fixant les règles d'organisation et de fonctionnement de l'Agence sénégalaise de Réglementation pharmaceutique
This Decree establishes and fixes the rules of organization and operation of the Senegalese Pharmaceutical Regulatory Agency (ARP)
Décret n° 2022-081/PR relatif à l’Institut National d’Assurance Maladie
The decree sets out the powers, organization, and operation of the Institut National d'Assurance Maladie. It was published in the Official Journal on 7 October 2022 (see pages 108 to 114).
Décret n° 2022-086/PR portant missions, composition, organisation et fonctionnement du comité de régulation de l’assurance maladie universelle
The decree sets out the missions, composition, organization, and operation of the "comité de régulation de l'assurance maladie universelle" (universal health insurance regulatory committee). It was published in the Official Journal on 7 October 2022 (see pages 137 to 140).
Décret exécutif No 21-224 du 12 Chaoual 1442 fixant les modalités d’établissement de la liste des médicaments essentiels
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).
Decreto Executivo No 426/21 Aprova a Lista Nacional de Medicamentos Essenciais
The Decree approves the National List of Essential Medicines.
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].
Décret No 2021-279/PRN/MSP/O/AS du 29 avril 2021, adoptant la Politique Pharmaceutique Nationale
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.
Décret No 2021-786/PRN/MSP/P/AS portant création d’un Etablissement Public à caractère social dénommé Institut National d’Assistance Médicale du 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.
Drugs and Related Products Registration Regulations
The Regulation sets up rules in the registration of drugs and related products manufactured, imported, exported, advertised, sold, distributed or used in Nigeria.