Role of an “Exploitant” in France: In the French pharmaceutical system, the “exploitant” is the legal entity responsible for the commercialization and distribution of a medicinal product once it is authorized.

Key Points

  • Regulatory role:
    • Holds the responsibility vis-à-vis ANSM (French Medicines Agency) for the product placed on the French market.
    • Ensures compliance with pharmacovigilance, distribution, sales, advertising rules, financial and regulatory obligations.
  • Operational role:
    • May differ from the MAH (Marketing Authorization Holder) if the MAH is not established in France.
    • The exploitant is the local interface between the manufacturer/MAH, the French authorities and administrative bodies.
  • Legal basis:
    • Defined under French Public Health Code (CSP, Article R.5124-2).

Sources

  1. ANSM – Responsibilities of the Exploitant
    https://ansm.sante.fr/activites/medicaments/exploitants-et-distributeurs
  2. Code de la Santé Publique – Article R.5124-2
    https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000006690421
  3. Leem – The role of the Exploitant in France
    https://www.leem.org/