Simplification of registration procedure for French person responsible for pharmacovigilance
09 April 2020
In February 2020, the French National Agency for Medicines and Health Products Safety (ANSM) announced that it had set up a new portal on its website, accessible from 1 March 2020, allowing the electronic registration of persons responsible for pharmacovigilance (RPVs) in France. The registration was previously carried out through email or post.
Under Article R5121-164 of the French Public Health Code (PHC), manufacturing authorisation holders as well as any organisation that handles medicinal products (as well as other products listed in Article R5121-50 PHC) must appoint, as part of their pharmacovigilance obligations, a qualified person responsible for pharmacovigilance. Once appointed, the company must disclose the identity, capacity and contact details of this person to the ANSM.
The RPV must be a French physician or pharmacist, residing and practising in France and must be able to demonstrate experience in pharmacovigilance. For companies operating throughout Europe, the RPV works under the EU qualified person responsible for pharmacovigilance (EU QPPV).
Companies that had already declared the identity and status of their RPV were required to register the RPV’s details on the new platform prior to 31 March 2020. New declarations (for example, following a change of RPV) must also be made on the platform.
This does not affect the declaration with regard to the EU QPPV, which must still be made and kept up to date on the EU “Article 57” database.
This article was co-authored by Alexandra Lauré.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2020 Issue (Thomson Reuters).