FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
Medical Devices Manufacturing plants of medical devices are generally not subject to prior authorisation, but they are required to register themselves on EUDAMED. However, pending the full operability of EUDAMED, manufacturers can use a national form provided by the ANSM. In this case, nation- al declarations are only valid in France. Manu- facturers of custom-made medical devices must also declare their activity to the ANSM before making such devices available on the national market. This declaration must include details of the type of activity performed and the devices concerned. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices The establishments engaged in wholesale of pharmaceuticals are subject to an authorisa- tion, while those engaged in wholesale of medi- Pharmaceuticals wholesalers (including acqui- sition, storage, supply or export, but excluding direct sales to the public) must be licensed as pharmaceutical establishments by the ANSM. The license process follows the same steps as for manufacturers (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices ). The applicant must submit a detailed application describing its distribution activities and dem- onstrating compliance with Good Distribution Practice (GDP), which is then reviewed by the ANSM and followed by an on-site inspection. cal devices are generally not. Pharmaceutical Wholesalers
( établissement pharmaceutique ) by the ANSM. Any company that includes at least one phar- maceutical establishment must be owned by a pharmacist or a company in which a pharma- cist participates in the management or general direction. • Manufacturers must submit a detailed appli- cation covering all manufacturing operations, including raw material procurement, produc- tion, quality control, batch release, and stor- age, in compliance with Good Manufacturing Practices (GMP). • Applications must be submitted via an online platform ( Démarches Simplifiées ). The ANSM reviews the application and conducts an on-site inspection. If all regulatory require- ments are met, the authorisation is granted and published in the EudraGMDP database. If the Director General of the ANSM does not issue a decision within 90 days of receiving the application, the request is automatically considered denied by default. • Each authorisation is issued per facility, requiring separate applications for each pro- duction site. However, a single authorisation may cover multiple manufacturing activities within the same establishment. • The authorisation remains valid indefinitely, provided the facility complies with GMP regu- lations and updates its authorisation in case of major modifications. In cases of non-com- pliance with the applicable regulations, the ANSM has the authority to suspend or revoke the authorisation. • Each manufacturer must also appoint a quali- fied person ( pharmacien responsable ) respon- sible for ensuring continuous compliance with quality and safety standards.
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