FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
7.2 Importer of Record of Pharmaceuticals and Medical Devices Companies or organisations licensed as phar- maceutical establishments by the ANSM may act as importers of record of pharmaceuticals (see 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices ). 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 representative. 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 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 speci- fied quantity. Import authorisation requests must be submitted via an online platform (Impexweb). If the ANSM does not respond within 45 days, the request is considered rejected. The ANSM may suspend or revoke an authorisation at any time. Except in urgent cases, such decisions can only be taken after allowing the authorisation holder to submit observations.
However, unlike for manufacturers, the absence of a decision from the ANSM within 90 days of receiving the application results in tacit approv- al, meaning that the authorisation is considered granted. Medical Devices Wholesalers Medical devices wholesalers generally do not require prior authorisation or specific registra- tion. Distributors making medical devices availa- ble on the French market, excluding direct sales to the public, must however declare their activity to the ANSM. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuti - cals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices 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 dedicated provisions of the Public Health Code. The ANSM is responsible for applying and enforcing regulations on the import and export of pharmaceuticals and medical devices.
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