QUALITY / REACTIVITY / ADAPTABILITY
STRICTER FRENCH REGULATION 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 (“exploitant”) or be associated with an operator.
MEDIXAL holds an operator authorization (“exploitant”) granted by the ANSM
(French drug agency) 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,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
(Marketing Autorisation holder and Operator) is done through a contract and specifications.
Why MEDIXAL
Unlike a large company, MEDIXAL is a company in its own right:
- agile
- reactive
MEDIXAL is a privileged partner
of the Pharmafield group
MEDIXAL adapts to the client in order to provide a tailor-made service in a very heavy regulatory context
Choosing MEDIXAL is to offer simplicity in a complicated regulatory context Translated with
MEDIXAL's staff has decades
of experience with French regulations in big pharma