FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
procedure implies that the marketing authorisation holder must fulfil specific obligations within defined timelines to confirm that the medicine’s benefits out- weigh its risks. 4.2 Regulatory Reliance France has not exactly embraced the notion of regula- tory reliance. Nevertheless, the ANSM is participating in pilot pro- grammes of mutual regulatory reliance managed by the EMA designed to assess the impact of using the results of regulatory inspections carried out by the regulatory authorities of third countries that are mem- bers of the Pharmaceutical Inspection Co-operation Scheme and by the United States Food and Drug Administration. Moreover, the EU has entered into a number of mutual recognition agreements with non-EU countries that define the conditions under which the EU member states will accept conformity assessment results (such as testing or certification) performed by con- formity assessment bodies designated by another non-EU member state and vice versa. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Manufacturing plants of pharmaceuticals are subject to an authorisation, while plants manufacturing medi- cal devices are generally not. Pharmaceuticals Manufacturing plants of pharmaceuticals must be licensed as pharmaceutical establishments ( établisse- ment pharmaceutique ) by the ANSM. Any company that includes at least one pharmaceutical establish- ment must be owned by a pharmacist or a company in which a pharmacist participates in the management or general direction. • Manufacturers must submit a detailed application covering all manufacturing operations, including raw material procurement, production, quality con-
trol, batch release, and storage, in compliance with Good Manufacturing Practices (GMP). • Applications must be submitted via an online plat- form ( Démarches Simplifiées ). The ANSM reviews the application and conducts an on-site inspection. If all regulatory requirements are met, the authori- sation is granted by the Director General of the ANSM and published in the EudraGMDP database. If the Director General of the ANSM does not issue a decision within 90 days of receiving the appli- cation, the request is automatically considered denied by default. • Each authorisation is issued per facility, requiring separate applications for each production site. However, a single authorisation may cover multiple manufacturing activities within the same establish- ment. • The authorisation remains valid indefinitely, pro- vided the facility complies with GMP regulations and updates its authorisation in case of major modifications. In cases of non-compliance with the applicable regulations, the ANSM has the authority to suspend or revoke the authorisation. • Each manufacturer must also appoint a qualified person ( pharmacien responsable ) responsible for ensuring continuous compliance with quality and Manufacturing plants of medical devices are generally not subject to prior authorisation, but they are required to register themselves on EUDAMED. However, pend- ing the full operability of EUDAMED, manufacturers can use a national form provided by the ANSM. In this case, national declarations are only valid in France. Manufacturers 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. safety standards. Medical Devices
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