Exploitant

Pharmaceutical companies bringing a product to market in Europe are sometimes not comfortable with the local requirements they must address in key markets.

The legal framework surrounding medicinal products in Europe is outlined in European Directive 2001/83/EC of November 6^th, 2001.

 At the European level, there are:

• 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.

 For wholesale distributors, France has created two categories and one being the “Exploitant”, a status entailing specific obligations.

The Exploitant is defined under the French Public Health Code as the organism responsible for drugs “exploitation”¹, under the responsibility of a Responsible Pharmacist “Exploitation” refers to any activity that applies to the commercial operation of medicinal products in France, including advertising, information, pharmacovigilance, storage and distribution (including batch follow up and recalls).

The French Health Authorities require that a specific organization is in place to guarantee a high level of compliance and ensure that all local specific requirements are covered. In other EU markets and, in accordance with the legal framework of the European Directive 2001/83/CE, the role is reduced to “distributor” or “wholesaler” with a focus on the storage and distribution activities, though the Exploitant has many other specific obligations.

The ‘Exploitant’ shares many of the same responsibilities as the marketing authorization holder, with additional obligations under French law.

These responsibilities include:

• Full accountability for pharmacovigilance activities.
• Must ensure that communications in France comply with regulations, clearly differentiating between advertising and medical or scientific information.
• Responsible for monitoring the supply chain, managing product distribution, and avoiding stock shortages in accordance with their strict obligations.
• Ensure that the manufacturer adheres to Good Manufacturing Practices (GMP) for the products.

Failure to comply with these obligations can result in penalties. Furthermore, the Exploitant must maintain close working relationships with all parties involved in the manufacturing and distribution of medicines