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4. Post-AMM risk monitoring methods
4.1 Spontaneous notification
Spontaneous reporting of adverse drug reactions is the cornerstone of any health alert system.
Spontaneous reporting refers to the transmission of an AR case by an observer to a pharmacovigilance structure. In France, the observer is usually a doctor, and the structure is an independent organization such as the Regional Pharmacovigilance Centers (CRPV).
The notification includes...
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Post-AMM risk monitoring methods
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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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