Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Fermer ce répertoire5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document5.1 France
Afficher le document5.2 India
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

5.1 France

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)".

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