What is an Exploitant?
#Exploitant #MarketAccess #FrenchMarketAccess
Cevidra offers exploitant services for medicinal products access to the French market. A local presence through a pharmaceutical structure operating as exploitant is a pre-requisite to the marketing of a medicinal product in France.
What is an exploitant?
In France, a medicine’s access to the market requires that the holder of the market authorisation (MA) or the holder a Temporary Use Authorizations (also called early access or previously ATU) also be an “exploitant” or have entered into a contract with an “exploitant”.
Definition
The “exploitant” is a pharmaceutical company whose activities are governed by an Opening Authorisation and a GDP (Good Distribution Practices) certificate and that is regularly inspected by the ANSM.
This status is specific to France as the European legal framework is not sufficient: legal provisions must be supplemented by the designation of an “exploitant”, acting as a local partner for the MAH.
Responsibilities
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.
The Qualified Person (“Pharmacien Responsable”)
For all exploitant entity, a Qualified Person (“Pharmacien Responsable”) is designated to be the Chief Pharmaceutical Officer, responsible for all pharmaceutical activities.
This person is the preferred contact for the ANSM. It is also required that the QP implements a back-up organization to ensure his/her replacement in case of absence by a Deputy QP.
Learn more about the exploitant status by watching our video
The role of the exploitant
Cevidra, acting as an exploitant*, is familiar with French regulation, interacts periodically with the French health authorities, and can provide support and expertise on the long journey to market entry.
* exploitant = the appointment of a local company acting as a pharmaceutical operator is mandatory for all companies wishing to place a medicinal product on the French market.
Cevidra’s Exploitant Services
Cevidra is acting as an independent pharmaceutical exploitant since 2007. Cevidra has developed its expertise over the last 17 years in various therapeutic areas with products of different nature:
Cevidra’s Services
Cevidra can cover all the legal and local requirements thanks to its knowledge of national laws and strong expertise in the exploitation of medicinal products.
Main takeaways
FAQ
France does not have an FDA. The equivalent authority of the FDA in France is the ANSM (Agence nationale de sécurité du médicament et des produits de santé), which regulates medicines and health products.
Sources
- ANSM – https://ansm.sante.fr
The main regulatory authority for pharmaceuticals in France is the ANSM (Agence nationale de sécurité du médicament et des produits de santé). It oversees drug approval, safety, pharmacovigilance, and market supervision. For health technology assessment and reimbursement decisions, the competent body is the HAS (Haute Autorité de Santé).
Pricing negotiations are handled by the CEPS (Comité économique des produits de santé).
The URSSAF oversees social security contributions and employer obligations, but it is not directly involved in the regulatory pathway of a medicinal product.
Sources
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
- ANSM – Responsibilities of the Exploitant
https://ansm.sante.fr/activites/medicaments/exploitants-et-distributeurs - Code de la Santé Publique – Article R.5124-2
https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000006690421 - Leem – The role of the Exploitant in France
https://www.leem.org/
