Le renforcement du système de pharmacovigilance de l'Union européenne. (Analyse du nouveau cadre réglementaire issu des dispositions de la directive 2010/84/UE et du règlement [UE] no 1235/2010)

The fundamental objective of the regulation of medicinal products is to safeguard public health. To achieve this aim, the European Union has decided to take measures in order to improve the operation of Union Law on the pharmacovigilance of medicinal products. The term “suspected adverse reaction” should be used when referring to reporting obligations and a risk management system should be applied.