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About EU and French environment
A VERY SPECIFIC EUROPEAN REGULATION IN EUROPE
The legal framework for medicinal products in Europe is defined
in the European directive 2001/83 / CE dated November 6, 2001.
At european level, there are 3 distinct status for the launch of drugs or medical devices:
• The marketing authorization holder (MAH), responsible for the marketing of the products, pharmacovigilance, advertising- medical information, batch monitoring and where applicable, recalls.
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• The manufacturer, with authorization granted by the Member State in which the manufacturing operations under his responsibility are carried out.
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• The distributor, responsible for wholesale distribution operations.​
IN FRANCE
Under the French legal framework, an operator wishing to market or distribute a medicinal product from and in France must hold an operator status (“établissement pharmaceutique exploitant”) or be associated with an operator.
MEDIXAL holds an operator authorization (“exploitant”) granted by the ANSM (French National Agency for Medicines and Health Products Safety) and is regularly inspected by the authorities.
The operator (“ exploitant “) is a specific French pharmaceutical status that applies to the marketing of medicinal products in France (art. R5124-2 3°,Public Health Code).
The operator in charge of the marketing activities in France must ensure that all pharmaceutical activities linked to the products for which it is responsible are carried out in accordance with the applicable regulations and laws.
The definition and control of pharmaceutical responsibilities between each stakeholder (MA holder and Operator) is done through a contract, specifications and quality agreements.
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