Article R. 5121-164 of the Public Health Code states that any company or organisation “exploiting” a medicinal product or a product mentioned in Article R. 5121-150 of the Public Health Code must have the services of a pharmacovigilance reference person (RPV) attached to the qualified person responsible for pharmacovigilance activities in Europe (EU QPPV).
The reference person (RPV) must meet the following criteria:
– be a doctor or pharmacist,
– reside and practice in France,
– to justify experience in pharmacovigilance.
The identity and status as well as the contact details of this person shall be communicated to the Director General of the ANSM as soon as he/she is appointed. Since 31 March 2020, this communication has been made on the Pharmacovigilance Reference Person (RPV) tele-registration portal with the following link : https://www.demarches-simplifiees.fr/commencer/ansm-declarationrpv-v1.
This electronic notification replaces the prior declaration made by post or e-mail.
Any changes to the identity, quality or contact details of the RPV are also made via this platform.
The correct receipt and acceptance of the file by ANSM is also communicated on this platform.
Our expert pharmacovigilance team is at your disposal and offers its assistance in filling in the electronic declaration form. Do not hesitate to contact us !