Benefits of using a third party Exploitant to run early access programs in France and more

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5 April 2022

BlueReg

Main benefits of outsourcing "Exploitant" status :

Reminder : French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. 

  • Immediate activation of French Affiliate
  • Access to rare skills and experienced team in France
  • Exploitant for your early access program as third party
  • Exploitant for your Marketing Authorization (MA) as third party
  • Peace of mind operations on French market
  • Transition after MA Approval and help to build your own French set-up

About the "Exploitant" status

At the European level, there are three separate positions:

  • The Marketing Authorisation holder (MAH), responsible for product marketing, pharmacovigilance, information-advertising, batch tracking and, where necessary, recalls.
  • The manufacturer, with authorization granted by the Member State in which the manufacturing operations under its responsibility are carried out.
  • The distributor, responsible for wholesale distribution operations.
    Regarding wholesale distributors, France has created two categories and one being the “Exploitant”, a status entailing specific obligations (more details below regarding these obligations).

Under the French legal framework, an operator that wants to market a medicinal product from and in France should hold an Exploitant status or partner with an Exploitant. The Exploitant operator is one of the pharmaceutical establishments authorized and regularly inspected by ANSM (French competent authority).

 

Exploitation is a pharmaceutical status that applies to commercial operations for medicinal products in France. In charge of placing the medicinal product on the market in France, the operator must ensure that all pharmaceutical activities associated with the products for which it is responsible are carried out in accordance with the applicable provisions.

 

The exploitation is ensured either by the holder of the marketing authorization/ early access program or by a partner with an Exploitant.

 

The Exploitant operations includes :

  • Wholesaling or free distribution;
  • Advertising ;
  • Medical information;
  • Pharmacovigilance
  • Monitoring of lots and, where appropriate, their withdrawal and, where appropriate, the corresponding storage operations.
    The Exploitant is accountable for the quality of the medicinal product placed on the French market and, in light of these obligations, must maintain close relations with key stakeholders (manufacturer and distributor).

Outsourcing Exploitant activities to a third party

  • PharmaBlue (a BlueReg company) is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted an early access program (EAP) or a marketing authorization (MA).
  • PharmaBlue holds an “Etablissement Pharmaceutique Exploitant” license from ANSM and as such can take over the organization and supervision of the distribution in France of pharmaceutical products, including advertising, information, pharmacovigilance, batch follow-up, and if required, batch withdrawal operations.

You are looking to market a medicinal product in France and you do not have Exploitant requirements ? Contact us

 

BlueReg

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