Chapter Ia: Pharmacovigilance

The purpose of pharmacovigilance is to monitor, assess, prevent and manage the risk of adverse reactions resulting from the use of the medicinal products and products mentioned in article L. 5121-1.

Any company or organisation exploiting a medicinal product or a product mentioned in article L. 5121-1 is required to comply with its obligations in terms of pharmacovigilance and, in particular, to implement a pharmacovigilance system and to record, report and monitor any adverse reaction suspected of being due to a medicinal product or product mentioned in the same article L. 5121-1 of which it is aware and to set up…

Doctors, dental surgeons, midwives and pharmacists report any suspected adverse reaction to a medicinal product or product mentioned in article L. 5121-1 of which they are aware. Other healthcare professionals, patients and approved patient associations may report any adverse reaction suspected of being due to a medicinal product or product mentioned in the same article L. 5121-1 of which they are aware.

The procedures for implementing this chapter shall be determined by decree in the Conseil d’Etat, in particular the procedures for organising the pharmacovigilance system for medicinal products and the products mentioned in article L. 5121-1 , as well as the procedures for detecting, collecting and analysing signals and the procedures for monitoring and providing feedback to the persons mentioned in article L. 5121-25.