The French pharmacovigilance system is characterized by :
a network of thirty one regional pharmacovigilance centres, located to prov
ide convenient proximity to healthcare professionals;
a causality assessment method, compulsory for all persons involved in pharm
acovigilance, to assess the causal relationship between an adverse effect a
nd one or more drugs;
if necessary, an additional evaluation of the causal relationship will be p
erformed using pharmaco-epidemiology methods;
a Technical committee and a National Commission of Pharmacovigilance which
centralise and assess all the data in order to provide a consensual advice
to the relevant authorities on necessary measures, to prevent, or reduce a
drug related adverse effect;
in the case of an inquiry, the pharmacovigilance department of the pharmace
utical company and the network of regional pharmacovigilance centers will p
ool their data with the aim to exchange information and ideas.