Amari A S G, Ouattara S, Koffi A A
Pharmacien, Docteur es-Sciences Pharmaceutiques (spécialité: Droit pharmaceutique), Enseignant-Chercheur en Législation pharmaceutique à l'UFR Sciences Pharmaceutiques et Biologiques de l'Université de Cocody Abidjan - Pharmacien chargé de la réglementation et du contentieux à la Direction de la Pharmacie et du Médicament (DPM) du Ministère de la Santé de Côte d'Ivoire. BPV 34 Université de Cocody-Aidjan. Email:
Pharmacien, membre du secrétariat de la cellule pour l'harmonisation de la Réglementation et de la Coopération Pharmaceutiques (CHRCP) de l'UEMOA.
Mali Med. 2012;27(2):6-12.
The purpose of this study was to describe Regulation No 06/2010/CM/UEMOA on procedures for Registration of Pharmaceuticals for human use in UEMOA member states to facilitate their implementation in the national legislation of each Member State.
Our study material was composed of the national laws of member states of UEMOA, the texts adopted at Community level relating to community management mechanisms of the drug in West Africa, and in particular regulations No 02/2005/CM/UEMAO on the harmonization of drug regulation in the member states of the UEMOA and No. 06/2010/CM/UEMOA. These texts were analyzed, their scope appreciated, and their origin studied.
The Regulation No 06/2010/CM/UEMOA describes all the procedures for obtaining a marketing authorization for a medicinal product in the Member States of the UEMOA. This regulation establishes a committee in charge of the technical evaluation of dossiers of application for approval and a national committee in charge of the drug definitive opinion on the request for approval, where the Minister of Health is the administrative authority issuing the marketing authorization.
The regulation makes a great UEMOA standardization of procedures for drug approval and guarantees the safety and quality of medicines circulating in the UEMOA.
本研究旨在描述关于西非国家经济货币联盟（UEMOA）成员国人类用药注册程序的第06/2010/CM/UEMOA号条例，以促进其在各成员国国家立法中的实施。
我们的研究材料包括UEMOA成员国的国家法律、在共同体层面通过的与西非药品共同体管理机制相关的文本，特别是关于UEMOA成员国药品监管协调的第02/2005/CM/UEMAO号条例和第06/2010/CM/UEMOA号条例。对这些文本进行了分析，评估了其范围，并研究了其来源。
第06/2010/CM/UEMOA号条例描述了在UEMOA成员国获得药品上市许可的所有程序。该条例设立了一个负责对审批申请文件进行技术评估的委员会和一个负责就审批申请给出药品最终意见的国家委员会，其中卫生部长是颁发上市许可的行政当局。
该条例极大地规范了UEMOA药品审批程序，并保证了在UEMOA流通药品的安全性和质量。
