Veterinary medicines and products for veterinary use
Projet de décret No. 2-22-06 pris pour l'application de la loi No. 21-80 relative à l'exercice, à titre privé, de la médecine, de la chirurgie et de la pharmacie vétérinaires (Draft Decree No. 2-22-06 implementing Law No. 21-80 on the private practice of veterinary medicine, surgery and pharmacy) Language(s): French Number of pages: 25
The notified draft Decree, updating the Decree implementing Law No. 21-80, is part of the support measures for the veterinary pharmacy sector, which are intended to supply the animal husbandry sector with safe and effective veterinary products by upgrading pharmaceutical production units.
The proposed draft text updates the regulatory provisions on the authorization/licensing of veterinary pharmaceutical establishments, marketing authorization for veterinary medicines, post-marketing surveillance (inspection, quality control and pharmacovigilance) and the regulatory approval of quality standards for all activities (good manufacturing and distribution practices) in line with scientific and technical developments.
This draft is intended to improve the regulatory framework for veterinary medicines significantly. It reworks the form and substance of the existing text. The principal amendments proposed aim to:
1. Better position the chief pharmaceutical officers of veterinary pharmaceutical establishments in the performance, manufacture, importation and distribution of veterinary medicines;
2. Update the legal framework for marketing authorizations for veterinary medicines and introduce a regulatory basis for the Joint Commission for Marketing Authorizations;
3. Lay down the principle of setting technical standards for evaluating the operation of the establishments: good manufacturing and distribution practices;
4. Provide details on market surveillance tools (inspection, quality control and pharmacovigilance);
5. Establish a legal framework for the administrative certifications required to export locally manufactured proprietary medicines (certificate of origin and free circulation (COLC), certificate of free circulation (CLC), certificate of a pharmaceutical product (CPP) and "CAT") and for the sanitary clearance of imported veterinary medicines.
This draft Decree repeals Decree No. 2-82-541 of 15 March 1983 implementing Law No. 21-80 on the private practice of veterinary medicine, surgery and pharmacy.