The ANSM’s FAQ on Good Pharmacovigilance Practices has recently been updated. This revision introduces several important clarifications, including the visibility of the Responsable de Pharmacovigilance (RPV) in PSURs, the visibility of the RPV in Risk Management Plans and risk minimisation measures, the use of the French causality assessment method, clarification regarding special situations, and expectations related to the quality of pharmacovigilance case reports.
This article provides a detailed overview of these new questions and their practical implications for marketing authorisation holders and operators.
