THE NEW REGULATIONS FOR THE APPROVAL OF MEDICINAL PRODUCTS IN IVORY COAST: APPLICATION OF REGULATION N ° 06/2010 / CM / WAEMU RELATING TO PROCEDURES FOR THE APPROVAL OF PHARMACEUTICAL PRODUCTS FOR HUMAN USE IN WAEMU MEMBER STATES
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 4
Abstract
Harmonization of procedures for the approval of medicines in the WAEMU area allows Member States to have a standard tool for the examination of applications for marketing authorization for medicinal products for human use. The objective of this study was to highlight the textual provisions adopted by a member state, Côte d'Ivoire for optimal application of the Community norm. The methodology used consisted, on the basis of a reminder of the main points of Regulation No. 06 / CM / UEMOA concerning the approval of medicinal products for human use, to show how the national implementing decrees taken in Côte d'Ivoire the Regulation. However, the need for Member States to act more expeditiously with regard to the application of Community standards is clear.
Authors and Affiliations
Amari ASG, Aka A, Pabst J Y
Keywords
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- EP ID EP329053
- DOI 10.22270/ijdra.v5i4.204
- Views 130
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