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2. Definitions
2.1 Pharmacovigilance
The law of December 29, 2011 on reinforcing the safety of medicines and health products states that the purpose of pharmacovigilance is to monitor, assess, prevent and manage the risk of adverse reactions resulting from the use of medicines and products mentioned in Article L 5121-1.
Pharmacovigilance applies in particular to all drugs benefiting from a Marketing Authorization (AMM), a Temporary Use Authorization (ATU) or a Temporary Use Recommendation (RTU), and is based on :
the collection of adverse reactions based on spontaneous reporting by healthcare professionals, patients, approved patient associations and manufacturers, with the support of...
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Definitions
Detecting and monitoring undesirable effects
Bibliography
- (1) - BLAYAC (J.P.) - Regard historique sur la mise en place de la première vigilance française : la pharmacovigilance. - Académie des Sciences et Lettres de Montpellier, 8 fév. 2010 http://www.ac-sciences-lettres-montpellier.fr/academie_edition/fichiers_conf/BLAYAC-2010.pdf ...
Websites
http://ansm.sante.fr/ (page consulted on November 26, 2015)
https://ansm.sante.fr/documents/reference/declarer-un-effet-indesirable
Regulations
Laws
Law no. 2011-2012 of December 29, 2011 on reinforcing the safety of medicines and health products
Law no. 98-535 of July 1 1998 on the reinforcement of health monitoring and control of the safety of products intended for human use.
Law no. 95-116 of February 4, 1995 on various social provisions
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