1. What is an “Exploitant”?
In the French pharmaceutical regulatory system, the Exploitant is the legal entity responsible for placing a medicinal product on the French market. It is the entity recorded on the Marketing Authorization (MA) that ensures the product complies with all regulatory, pharmacovigilance, and distribution obligations in France.
2. Is the exploitant the same as the Marketing Authorization Holder (MAH)?
Not always.
- The MAH holds the EU or French MA, which can cover multiple countries.
- The exploitant is specific to France and is responsible for the day-to-day operations of marketing the product there.
In some cases, the MAH and exploitant are the same company; in others, the MAH appoints a local partner as exploitant.
3. Why is an exploitant required in France?
French law requires a company established in the EU (and compliant with French requirements) to act as the local interface between health authorities and the MAH. This ensures:
- Local pharmacovigilance
- Supply continuity
- Compliance with local promotional rules
- Accountability for product distribution and recalls
4. Can a foreign company be its own exploitant?
Yes, provided the company is established in the EU/EEA and meets the French regulatory requirements (including having a French pharmacovigilance contact, a French qualified person for batch release if applicable, etc.). Otherwise, they must appoint a French-based exploitant.
5. What are the main responsibilities of the exploitant?
The exploitant is responsible for:
- Ensuring regulatory compliance of the product in France
- Pharmacovigilance and medical information services
- Batch release oversight in France
- Marketing and promotion of the product
- Communication with French authorities (ANSM, CEPS, etc.)
- Managing distribution and recall processes in France
6. How is an exploitant appointed?
The MAH designates the exploitant when submitting the MA in France. If they later change exploitants, this must be notified to ANSM with supporting documentation and updated agreements.
7. Can there be more than one exploitant per product?
No. A single product can only have one exploitant at a time per MA in France. However, a company may act as exploitant for several products from different MAHs.
8. Does the exploitant own the product?
No. The MAH retains ownership of the MA and intellectual property. The exploitant is a service and compliance partner, acting on behalf of the MAH for the French market.
9. What should I consider when choosing an exploitant?
Key criteria include:
- Proven regulatory and pharmacovigilance expertise
- Established infrastructure in France
- Experience in your therapeutic area
- Ability to manage your product portfolio professionally
- Clear, transparent contractual terms
10. Where can I find an exploitant?
Many companies specialize in exploitant services in France. We can guide you, contact us for a free consultation at hello@elliogen.com
Leave a Reply