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.

  • ASG Amari Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny, Abidjan, Côte d 'Ivory
  • A Aka Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny, Abidjan, Côte d 'Ivory
  • J Y Pabst Pharmacist, Professor, Pharmaceutical Law and Economics, Faculty of Pharmacy, University of Strasbourg, France

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.
 

Keywords: Harmonization, Homologation, UEMOA, Ivory Coast.

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Author Biographies

ASG Amari, Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny, Abidjan, Côte d 'Ivory

Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR
of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny,
Abidjan, Côte d 'Ivory

A Aka, Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny, Abidjan, Côte d 'Ivory

Pharmacist, Associate Lecturer, Department of Galenics and Pharmaceutical Legislation of the UFR
of Pharmaceutical and Biological Sciences at the University Félix Houphouet Boigny,
Abidjan, Côte d 'Ivory

J Y Pabst, Pharmacist, Professor, Pharmaceutical Law and Economics, Faculty of Pharmacy, University of Strasbourg, France

Pharmacist, Professor, Pharmaceutical Law and Economics, Faculty of Pharmacy,
University of Strasbourg, France

References

1. Côte d'Ivoire. Conditions of registration and
dispensing of medicines in Côte d'Ivoire. Official
Journal of the Republic of Côte d'Ivoire. Decree No.
94-669 of 1994 Dec 21; 1994.
2. West African Economic and Monetary Union
(UEMOA). Regulation No. 06/2010 / CM / UEMOA
on procedures for the approval of pharmaceutical
products for human use in WAEMU member States;
2010.
3. Côte d'Ivoire. Establishing, organizing and operating
the Expert Committee for the Technical Evaluation of
Applications for the Registration of Medicinal
Products Official Journal of the Republic of Côte
d'Ivoire. Decree No. 2015-569 of 2015 July 29; 2015.
4. Côte d'Ivoire. Establishing, organizing and operating
the National Medicines Committee. Official Journal
of the Republic of Côte d'Ivoire. Decree No. 2015-
568 of 2015 July 29; 2015.
5. Côte d'Ivoire. Laying down fees for the authorization
to place medicinal products on the market. Official
Journal of the Republic of Côte d'Ivoire. Decree No.
2015-602 of 2015 Sept 2; 2015.
6. Côte d'Ivoire. Fixing the rate and terms of payment of
the registration fee for proprietary medicinal
products. Official journal of the Republic of Côte
d'Ivoire; Decree No. 66-382 of 1966 Sept 9; 1966.
7. Côte d'Ivoire. Amending the registration fee for
pharmaceutical products. Official Journal of the
Republic of Côte d'Ivoire. Decree No. 75-364 of 1975
Sept 22; 1975.
8. Community code relating to medicinal products for
human use. Official Journal of European Community
(OJEC) Directive 2001/83 / EC; 2001.
9. Community code relating to medicinal products for
human use. Official Journal of European Community
(OJEC) Directive 2001/83 / EEC; 2004.
10. West African Economic and Monetary Union
(UEMOA). Regulation No. 02/2005 / CM / UEMOA
on the harmonization of pharmaceutical regulations
in WAEMU Member States; 2005.
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How to Cite
Amari, A., A. Aka, and J. Y. Pabst. “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.”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 4, Dec. 2017, pp. 1-7, doi:10.22270/ijdra.v5i4.204.