About the "Exploitant" status in France

Exploitant

Under the French legal framework, an pharmaceutical player wishing to operate in and from France must hold an Exploitant status or partner with an Exploitant.

 

The different statuses

About the “Exploitant” status

The legal framework surrounding medicinal products in Europe is outlined in European Directive 2001/83/EC of 6 Nov. 2001.

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 for pharmaceutical operations (more details below regarding these obligations).

Under the French legal framework, an pharmaceutical player wishing to  operate  in and from France must hold an Exploitant status or partner with an Exploitant.

The Exploitant player is a  pharmaceutical establishment authorized and regularly inspected by ANSM (French competent authority).

 
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The Exploitant operations are detailed in Article R. 5124-2 3° of the Public Health Code. They include the following pharmaceutical operations :

  • Wholesaling or free distribution;
  • Advertising ;
  • Medical information;
  • Pharmacovigilance: the obligations of the operator are mentioned in articles R. 5121-162 to R. 5121-177 of the French Public Health Code, from which it emerges an obligation of surveillance and proactivity of the operator with regard to the pharmacovigilance of the medicines it places on the French market;
  • Monitoring of lots and, where appropriate, their withdrawal as well as when applicable any 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).

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About the "Exploitant" Chief Pharmaceutical Officer

  • French law places pharmaceutical responsibility in the hands of a named person, the Chief Pharmaceutical Officer – CPO (“Pharmacien Responsable”).
  • This status is specific to France and derives directly from the pharmaceutical monopoly.
  • The presence of a CPO is required in all pharmaceutical companies in France, irrespective of their activities.
  • The role is defined in Art R. 5124-36 of the Public Health Code, as:

The CPO organizes and oversees all the pharmaceutical operations of the company or organization, particularly manufacturing, advertising, information, pharmacovigilance, batch tracking and recall, the distribution, importing and exporting of medicinal products, devices, objects or related items as well as the corresponding storage operations […].”

  • The CPO responsibilities are broader than those of the “Qualified person” defined at European level.
  • The CPO is a corporate officer, who organizes and oversees all pharmaceutical activities. Its unique position in the company makes it the privileged interlocutor of the health authorities. He is a senior member of the company with a status of General Manager (Art R.5124-34 and Art R.5124-36), personally practicing his profession (Art. L 5124-2) and he has an experience appropriate practice (Art. R.5124-16). Her/his personal responsibility is engaged as a guarantor of the quality of the medication and the safety of the patients.
  • At least one deputy-CPO must be appointed to guarantee the continuity of the pharmaceutical responsibility during the absence of the CPO.

Exploitant services for MAA product

Case study

PharmaBlue is part of the BlueReg family, an integrated service within the global european regulatory affairs consulting group. PharmaBlue is authorized by ANSM in France as an “Exploitant” establishment…


Read the case
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