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[Descriptive study of the regulation N°06/2010/CM/UEMOA on procedures followed for registration of pharmacticals for human use in UEMOA member states].

Authors: A S G, Amari; S, Ouattara; A A, Koffi;

[Descriptive study of the regulation N°06/2010/CM/UEMOA on procedures followed for registration of pharmacticals for human use in UEMOA member states].

Abstract

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.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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