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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”.
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 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.
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.
Specifications for Essential Medicines Supplies
Specifications for essential medicines supplies.
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.
Pharmacy and Medicines Regulatory Authority Act
This Act establishes the Pharmacy and Medicines Regulatory Authority; provides for the functions and powers of the Authority; and provides for matters connected therewith and incidental thereto.
Loi N° 2017-541 du 3 août 2017 relative à la régulation du secteur pharmaceutique
The objective of the law is to establish an institutional framework for regulating the pharmaceutical sector to ensure market approval and use of pharmaceutical products that are accessible, safe, efficient, and of appropriate quality (art.2). It notably establishes the Authority for pharmaceutical regulation (Autorité Ivoirienne de Regulation Pharmaceutique - AIRP) and addresses its mandates (chapter 1).
Lei No 12/2017 Lei de medicamento, vacinas e outros produtos biológicos para o uso humano
This Law establishes the rules for the efficient and safe production, distribution, use and availability, as well as quality assurance of medicines, vaccines, biological and health products for citizens.
The National Medical Supplies Agency Act
This Act repeals and replaces the National Pharmaceutical Procurement Unit Act, 2012 to establish the National Medical Supplies Agency as a public service agency responsible for the procurement, warehousing and distribution of drugs and medical supplies in a transparent and cost-effective manner for and on behalf of all public institutions throughout Sierra Leone.
Medicines and Related Substances Control Act, 2015
This Act provides for the establishment of a Medicines Regulatory Authority; for the registration of medicines and medical devices; for the control of medicines and scheduled substances, and for incidental matters.
Procedures for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products
These are the guidelines for the registration, renewal, change in characteristics and extension in range of both imported and locally manufactured registered pharmaceutical products.
Lignes directrices sur l’approvisionnement en médicaments essentiels en République Démocratique du Congo
This document provides guidelines on the supply of essential medicines in the Democratic Republic of Congo.
Arrêté ministériel No 120/CAB/MIN/SP/008/CPH/OBF/2015 portant règlementation du commerce des produits pharmaceutiques en République Démocratique du Congo
This Ministerial decree regulates the trade of pharmaceutical products in the Democratic Republic of the Congo.
Regulation No 299/2013 Food, Medicine and Health Care Administration and Control
This regulation is issued to implement the Food Medicine and Health Care Administration and Control Proclamation No 661/2009. and covers among other aspects of food safety and quality which includes manufacturing, storage and transportation among other aspects; sale of alcohol; medicine administration and control which includes manufacturing, registration, storage, transportation, importation ad clinical trials among others; traditional and complementary medicine administration and control; post-marketing surveillance; control of tobacco products and places prohibited for smoking among other aspects.
Medicines and Related Products Act
The Act regulates the quality and safety of medicines and related products and connected matters.
The National Drug Policy and Authority (Issue of Licenses) Regulations
These Regulations govern the issuance of licenses for the importation, exportation, manufacture, distribution, and retail of drugs, etc.
Medicines and related substances Act
This Act provides for the registration, regulation of the sale, distribution, importation, exportation, manufacture and dispensing of medicines and related substances, and matters incidental thereto.