(1995; 156 pages)
Currently, there are 342 licensed original manufacturers, 35 unlicensed contract manufacturers and 12 manufacturers attached to pharmacies in France. Pharmaceuticals are produced by both contract and original manufacturers.
Regulation of pharmaceuticals is carried out at central and regional level. Evaluation and registration of products, licensing of establishments, issuance of import permit and product certificate and GMP certificate, as well as quality control activities, are carried out at the central level. Regional agencies do pharmaco-vigilance and inspection services jointly with the central authorities.
Manufacturing plants intending to export pharmaceuticals are obliged by Article L 603 of the Law No.92-1279 of December 1992, to have GMP Certificates. Marketing authorization is also required by Article L 601 of the same law to export pharmaceutical products. However, pharmaceutical products for export are not required to be controlled or subjected to evaluation to obtain marketing authorization as is the case with locally used pharmaceuticals. The issue of a Certificate of a Pharmaceutical Product is not a requirement for obtaining an export license.*
* According to information received after the assessment, in France ..."products without Free Sale certificate (AMM) are henceforth exported accompanied with a declaration of exportation in agreement with the decreed application of Article L 603 created in June 1994. This document is included in the certificate of exportation and replaces the outdated "Authorization of Exportation" which no longer exists."
The report also shows that out of 231 pharmaceutical wholesalers in France, 26 carry out export activities exclusively. In addition, hospital pharmacies and charitable associations export pharmaceuticals, often without getting their drugs registered.
Certificates issued by the regulatory authorities include: Attestation of Free Sale according to L 601, Certificate of Free Sale for product according to L 603, GMP Certificate and Certificate of a Pharmaceutical Product (WHO 1975 type).**
** Also..."In Accordance with the Law 92 179 of December 1992, certificates issued after June 1994 by the authority will include:
- Free Sale Certificate (AMM) according to L 601 (Certificate de libre vente);
- Export Certificate according to L 603 (Déclaration d'exportation);
- Certificates of legal existence of the establishment (Arreté d'ouverture d'établissement pharmaceutique);
- Certificate of Good Manufacturing Practices (délivré par l'Inspection, non conforme OMS), not in accordance with WHO;
- Certificate of a Pharmaceutical Product (WHO 1975 type); (délivrance non systématique)".