Whenever we think about Pharmacovigilance in France, two things come to mind. First is the French Imputability Method of Causality, and the second is ‘Exploitant.’ The concept of ‘Exploitant’ is specific to France. Under the French legal framework, a Marketing Authorization Holder (MAH) which wants to market a medicinal product in France, needs to hold an Exploitant status or partner with an Exploitant locally in France. The Exploitant is generally an authorized pharmaceutical establishment that gets regularly inspected by ANSM (French regulatory agency). The Exploitant is responsible for Medical Information and Pharmacovigilance activities in France.

The Exploitant or a company or body operating a drug or product mentioned in article R. 5121-150 needs to implement a pharmacovigilance system to fulfill its obligations in terms of pharmacovigilance, and in particular to carry out the collection and scientific evaluation of all the information (Medical Information) relating to the undesirable effects mentioned in article R. 5121-151, with the aim of prevention and risk reduction and, if necessary, to take appropriate measures.

Pharmacovigilance System Master File

Any company or body operating a drug or product mentioned in article R. 5121-150 needs to manage a Pharmacovigilance System Master File (PSMF) and needs to make it available within seven days, at the request of the director-general of ANSM.

Audits and Inspection

An audit of the pharmacovigilance system needs to carried out and recorded in the PSMF. Based on these results, an action plan to remedy the problems noted must be implemented.

Once the corrective measures have been fully implemented, the entered records may be deleted.

Periodic Safety Update Reports By way of derogation from the provisions of article R. 5121-168, the Exploitant, in accordance with the procedure provided for in 1 ° of articles R. 5121-26 and R. 5121-28 and in article R. 5121-97 is required to submit a PSUR under the following conditions: 1. Under the conditions determined by the marketing authorization or registration; 2. At the request of the Director-General of the ANSM : (a) When ANSM has concerns relating to pharmacovigilance data; (b) Or when there is no PSUR for an active substance after the marketing authorization has been granted.

At the end of the day, both MAH and Exploitant are equally accountable for Pharmacovigilance compliance.

While the MAH is concerned about its license, the Exploitant may be more concerned about its business.