Pharmacovigilance inspections

Since May 2008 the Federal Agency for of Medicines and Health Products (FAMHP) has implemented its national programme of pharmacovigilance inspections. These inspections are intended to ensure that holders of marketing authorisation of medicines for human and veterinary use have a person responsible for pharmacovigilance (QPPV: Qualified Person for Pharmacovigilance) and a pharmacovigilance system in line with the regulation.

In order to at best organize the pharmacovigilance inspections of the companies, the circular 520 reminds the reader of some of the legal obligations incumbent upon marketing authorisation holders and announces the establishment of a system for collecting information in the preparation of these inspections, using a form / form that can be downloaded.

Last updated on 20/01/2009