9. Glossary
alert ; alert
Signal validated after risk assessment, requiring the implementation of precautionary measures and/or preventive or corrective actions.
base nationale de pharmacovigilance; french pharmacovigilance database
A database managed by ANSM (the French National Agency for Medicines and Health Products) containing adverse reaction observations reported by healthcare professionals and entered by CRPVs after evaluation, validation and attribution.
adverse effect; effet indésirable
Any noxious and unintended reaction occurring at dosages normally used in humans, for all conditions of use.
serious adverse effect; effet indésirable grave
A lethal or life-threatening effect, or one resulting in significant or lasting...
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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
...
Appendix: Adverse reaction reporting form
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