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PubMed · 10472690

[Pharmacovigilance in practice].

A Spreux·B Baldin·R M Chichmanian
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Abstract

Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of drugs after they have been provided by AFSSAPS with official marketing authorizations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical products are concerned which are used either for treatment (all drugs and remedies, inclusive plasma-derived blood products), prevention (vaccines, oral contraception), diagnosis (contrast products, ...), or to modify a physiologic function (general or local anesthetics). At the national level, the main actors of the system are AFSSAPS and its National Commission, the 31 Regional Centers of Pharmacovigilance, all the health professionnals, and the pharmaceutical laboratories. Health professionnals are held to notify any suspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and inquiries about drug safety. Furthermore regional centers of pharmacovigilance are responsible for drug information. The French pharmacovigilance system works in cooperation with the European Agency for the Evaluation of Medicinal Products.

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Adverse Drug Reaction Reporting SystemsEuropean UnionFranceInternational CooperationProduct Surveillance, PostmarketingWorld Health OrganizationEnglish AbstractJournal Article

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A Spreux, B Baldin, R M Chichmanian. 1999. [Pharmacovigilance in practice].. https://doi.org/10.1016/s1246-7820(99)80036-6

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