Exploitant in France: Complete Guide

Introduction

If you’re a pharmaceutical or biotech company looking to commercialize medicines in France, understanding the “Exploitant” role is essential. This unique regulatory requirement can make or break your market entry strategy.

In this guide, you’ll learn:

What an Exploitant is and why it exists
The legal requirements and responsibilities
How it differs from the Marketing Authorisation Holder (MAH) or distributor
How to choose and work with the right Exploitant
How Elliogen helps companies navigate the Exploitant process

1. What is an Exploitant?

Definition

In France, an Exploitant is the entity legally responsible for placing a medicinal product on the French market. The exploitant ensures compliance with pharmacovigilance, quality, advertising, and distribution obligations under French law.

2. Legal Framework and Requirements

The Legal Basis

The role of exploitant is defined under the French Public Health Code (Code de la Santé Publique) and enforced by the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé).

Key Requirements

An exploitant must:

Hold an authorisation from the ANSM
Have an established presence in France
Maintain qualified staff (including a pharmacien responsable)
Ensure product quality, batch release, and regulatory compliance
Manage pharmacovigilance and advertising controls

3. Exploitant vs. MA Holder vs. Distributor

Role	Primary Responsibility	Location Requirement	Legal Authority
Exploitant	Responsible for placing product on the French market & compliance	Must be in France	Authorised by ANSM
MA Holder (MAH)	Owns the marketing authorisation	Can be in EU or EEA	Authorised by EMA/ANSM
Distributor	Physical distribution of medicines	Can be anywhere	Works under MAH/Exploitant

4. Responsibilities of an Exploitant

Regulatory & Compliance

Ensure compliance with ANSM and EU rules
Manage pharmacovigilance systems
Approve and monitor promotional activities

Quality & Supply

Oversee manufacturing batch release in France
Ensure product quality and recall readiness

Commercial Accountability (H3)

Maintain accurate product information for healthcare professionals and patients

5. When Do You Need an Exploitant?

You will need an exploitant if:

You are a non-French pharma company marketing a product in France
You are launching a product but don’t have an entity in France with ANSM approval
You are outsourcing pharmacovigilance, batch release, or regulatory tasks

6. How to Choose the Right Exploitant

Criteria to Consider

Experience with your therapeutic area
Pharmacovigilance capabilities
Compliance track record with ANSM
Speed of onboarding and responsiveness
Commercial and distribution partnerships

7. Working With an Exploitant: Best Practices

Sign clear contractual agreements on roles and responsibilities
Maintain ongoing communication for regulatory updates
Schedule regular performance and compliance reviews

8. Elliogen’s Role in the Exploitant Process

At Elliogen, we are not an exploitant — we are your independent advisor.
We help pharmaceutical companies:

Identify and compare exploitants suited to your needs
Negotiate agreements to protect your commercial interests
Set up compliance frameworks to avoid regulatory issues
Streamline market entry while maintaining flexibility

Example: A US biotech wanted to enter France but had no entity there. Elliogen helped them assess 3 exploitants, select the best fit, and ensure compliance in under 4 months.

9. Directory of Exploitants in France

10. Frequently Asked Questions

Q: Can a foreign company be an exploitant in France?
A: Only if it has a physical presence in France and ANSM authorisation.

Q: How long does ANSM exploitant approval take?
A: Typically 3–6 months, depending on dossier quality and inspections.

Q: Can the MA Holder also be the exploitant?
A: Yes, if they meet all legal requirements.

Ready to enter the French market?
Contact Elliogen today to find the best Exploitant for your needs and accelerate your market access.