About the "Exploitant" status

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 (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 (Art. R5124-2). 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.

 

As mentionned above, the exploitation is ensured either by the holder of the marketing authorization mentioned in article L. 5121-8, of the temporary authorization of use mentioned in 1 ° of I of the article L. 5121-12 or one of the registrations mentioned in Articles L. 5121-13 and L. 5121-14-1, that is, on behalf of this holder, by another company or another organization, or by one and the other, each providing in this case one or more categories of operations constituting the exploitation of the drug or product. The definition and control of pharmaceutical responsibilities between each stakeholder is via a contract and specifications.

In Article R. 5124-2 3° of the Public Health Code, Exploitant is understood to mean: “The company or organization providing the exploitation of medicinal products […]

 

The Exploitant operations includes :

  • Wholesaling or free distribution;
  • Advertising ;
  • Medical information;
  • Pharmacovigilance: the obligations of the operator are mentioned in articles 5121-162 to R. R. 5121-177 of the CSP, from which it emerges an obligation of surveillance and proactivity of the operator with regard to the pharmacovigilance of the medicines he places on the French market;
  • 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). 

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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).

 

The concept of responsibility is very important, and it is important that it be visible in a company organization chart with mention of the hierarchical links and delegations: Pharmacist Manager, Interim Lead Pharmacist in the absence of the Chief Pharmacist, Assistant Pharmacists and Delegates . It is his personal responsibility that is engaged as a guarantor of the quality of the medication and the safety of the patients.

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