France

The European pharmacovigilance requirements are implemented into French law by decree No. 95-278, dated 13 March 1995, as codified in the French Public Health Code. The competent authorities responsible for pharmacovigilance are the French Agency for the Sanitary Safety of Health Products (AFSSAPS), the National Pharmacovigilance Commission (Commission

Nationale de Pharmacovigilance) and the Technical Committee (Comite Technique).

The French Public Health Code requires medical doctors, dental surgeons and midwives to report any serious or unexpected adverse reaction in relation to a medicinal product, whether or not they have actually prescribed the product. Pharmacists are also obliged to report serious or unexpected adverse reactions relating to products that they have dispensed. Reports are filed in a prescribed form (see Appendix 9) at the nearest regional centre, which forwards the data to the AFSSAPS. Voluntary reporting for adverse reactions which are not serious or unexpected may also be filed at the nearest regional centre. The Technical Committee is responsible for coordinating and evaluating the data provided by regional centres. Regional centres are obliged to forward information relating to serious adverse reactions to the AFSSAPS directly.

In accordance with the European regulatory requirements, the French Public Health Code requires the "pharmacien responsable'' (qualified person) of all pharmaceutical companies to report every serious adverse reaction in relation to its products to the Director of the AFSSAPS. All pharmaceutical companies must maintain a phar-macovigilance department and the directors' names must be registered with the AFSSAPS.

The requirements in Volume 9 were implemented into the French Public Health Code by Article 23 of Law No. 2002-303, dated 4 March 2002. In particular, Article 23 inserts a new Article L.1413-14, requiring health care professionals and health establishments to report any suspected adverse reactions that they become aware of to the competent authority.

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