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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 2023-422 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 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 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.
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.
Arrêté du 11 Joumada El Oula 1442 fixant la procédure de fixation des prix des médicaments par le comité économique intersectoriel des médicaments
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).
Arrêté nº 2020-407/MS/CAB portant Liste nationale des médicaments essentiels et autres produits de santé du Burkina Faso
The order establishes the national list of essential medicines and other health products in Burkina Faso.
Decreto No 115/2020 Aprova o Estatuto Orgânico da Autoridade Nacional Reguladora de Medicamento
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.
Medicines and related substances regulations
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.
Arrêté No 2019-2521/MSHP-SG fixant la liste Nationale des Médicaments Essentiels en Dénomination Commune Internationale
The document establishes the list of essential medicines in the Republic of Mali.
Arrêté No 110 MSP/SG/DGSP/MT portant révision de la Liste Nationale des Médicaments Essentiels
The decree revises Niger's national list of essential medicines.
Diploma Ministerial No 21/2017 Aprova o Reglamento de fixaçao de preços de medicamentos
This Regulation establishes the pricing system for medicinal products. All medicines circulating in Mozambique shall be subject to the pricing system provided for in these regulations.