We are pleased to share our summary of the revision of the Good Practices of PharmacoVigilance in France: although this revision does not bring major changes to the national system, it adds clarifications on the processes in place as well as an update of the description of the processes that have evolved since the previous version of the document.
Among the amendments to the text, we’ve highlighted the following:
- Addition and modification of a certain number of definitions, particularly concerning special situations.
- Concerning healthcare professionals: clarification on the obligations and possibilities in terms of reporting cases as well as on the modalities of these reports.
- Concerning patients: declaration to the centers for evaluation and information on drug dependence has been added.
- For Marketing Authorization Holders/ “Exploitant”:
- Updated the RPV (Reference person for pharmacovigilance in France) declaration requirements to ANSM.
- Additional responsibilities for the RPV: monitoring product information updates
- Clarification on PV case documentation, particularly for patients.
- Addition of the reporting procedures for Emerging safety Issues.
- Reinforcement of the “Exploitant”’s involvement in the management of risk minimization measures.
- Reinforcement/Details concerning the traceability of indicators and quality controls.
- Concerning the CRPVs (Regional Pharmacovigilance Centers): strengthening their involvement in the management of medication errors and signals.
Consequently, our recommendations for action:
- For RPVs/“Exploitants”, ensure that they have the means to carry out their additional responsibilities.
- Verify the content of quality documents and other documents (training materials, safety data exchange agreements, etc.) in order to integrate the various clarifications provided by this text.
We remain, as always, at your disposal for any additional clarification. Do not hesitate to contact our expert.
