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.
For more information: https://www.vigiservefoundation.org/blog-post/exploitant-france-pv/
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.
For more information: https://www.vigiservefoundation.org/blog-post/exploitant-france-pv/
