FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices The establishments engaged in wholesale of pharma- ceuticals are subject to an authorisation, while those engaged in wholesale of medical devices are gener- ally not. Pharmaceutical Wholesalers Pharmaceuticals wholesalers (including acquisition, 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 Authorisa- tion for Manufacturing Plants ). The applicant must submit a detailed application describing its distribution activities and demonstrating compliance with Good Distribution Practice (GDP), which is then reviewed by the ANSM and followed by an on-site inspection. However, unlike for manufacturers, the absence of a decision from the ANSM within 90 days of receiving the application results in tacit approval, meaning that the authorisation is considered granted. Medical Devices Wholesalers Medical devices wholesalers generally do not require prior authorisation or specific registration. Distributors making medical devices available on the French mar- ket, excluding direct sales to the public, must however declare their activity to the ANSM. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Categories of Pharmaceuticals and Medical Devices .
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies Importation and exportation of pharmaceuticals are mainly regulated by dedicated provisions of the Public Health Code. Importation and exportation of medical devices are mainly regulated by EU law (MDR and IVDR) and dedi- cated provisions of the Public Health Code. The ANSM is responsible for applying and enforcing regulations on the import and export of pharmaceuti- cals and medical devices. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Companies or organisations licensed as pharmaceuti- cal establishments by the ANSM may act as importers of record of pharmaceuticals (see 5.1 Requirement for Authorisation for Manufacturing Plants ). With respect to medical devices, any natural or legal person can act as an importer of record. EU law assigns specific regulatory obligations to importers, particularly when the manufacturer is located outside the EU and has not appointed an authorised EU rep- resentative. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The importation of pharmaceuticals and medical devices is subject to prior authorisations. Pharmaceuticals The importation of pharmaceuticals into France, including from another EEA country, requires prior authorisation from the ANSM, which may be granted for: • a single import operation (valid for up to three months); or • a series of imports over one year for a specified quantity.
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