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?
Cevidra’s exploitant services

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:

  • Wholesale and batch monitoring

      • Product Sales or free transfer
      • Management of product quality issues (complaint, recall…)
      • Storage, Distribution & Batch Traceability
      • Prevention of shortages and introduction of falsified medicines
  • Advertising and promotional activities

      • Promotion of medicines by a sales force Promotional information and material validation/follow-up
      • Compliance with anti-gift and transparency law
  • Post market surveillance

      • Medical information
      • Pharmacovigilance – provision of a local PV person*

* 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