The exploitant is accountable for placing on the French market a medicine that complies with its marketing authorization and the requirements of the French regulation.
Regarding these obligations, the exploitant must maintain close relations with all the key stakeholders (Health agency, MA holder, manufacturer, and distributor if different). He is the guarantor of compliance with the supply chain and the proper use of the drug.
The responsibilities of the exploitant are defined in the Public Health Code (Article R5124-2) and the its missions are organized around 3 axes:
* In France, pharmacovigilance is based on the national and European regulatory framework. The registration of a local Person Responsible for Pharmacovigilance (RPV) is required. The RPV ensures that the obligations related to risk reduction actions and the implementation of post-authorisation safety studies are respected on the national territory. They are responsible for the effective provision of risk reduction documents.