FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
spécialités pharmaceutiques and the relevant documents (ie, the summary of product char- acteristics and the patient information leaflet). Otherwise, the ANSM publishes the summary report of the assessment carried out for each new medicinal product as well as the decisions to grant, suspend or withdraw marketing author- isation. The ANSM also publishes the agendas and minutes, with details and explanations of votes (including minority opinions), of the meet- ings of its commissions, committees and expert collegial bodies, excluding any information cov- ered by business or medical secrecy. Medical Devices For medical devices, information may be pub- licly accessed via EUDAMED, which is currently being deployed by gradual roll-out. Once fully functional, EUDAMED will ultimately be com- posed of six modules: • actor module; • unique device identification (UDI) and device module; • notified bodies and certificates module; • market surveillance module; • vigilance and post-market surveillance and vigilance module; and • clinical investigations and performance stud- ies module. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes The French regulatory framework does not spe- cifically foresee fast-track registration routes for pharmaceuticals and medical devices. Only pharmaceuticals subject to the centralised pro- cedure (at EU level) may benefit from expedited reviews, namely those of major public health
interest for public health and therapeutic inno- vation or those addressing diseases with a high unmet need, based on less comprehensive clini- cal data than normally required. 4.2 Regulatory Reliance France has not exactly embraced the notion of regulatory reliance. Nevertheless, the ANSM is participating in pilot programmes of mutual regulatory reliance man- aged 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 members of the Pharmaceuti- cal 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 certifica- tion) performed by conformity assessment bod- ies 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 of Pharmaceuticals and Medical Devices Manufacturing plants of pharmaceuticals are subject to an authorisation, while plants manu- facturing medical devices are generally not. Pharmaceuticals Manufacturing plants of pharmaceuticals must be licensed as pharmaceutical establishments
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