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.