FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
Pharmaceuticals For pharmaceuticals, a marketing authorisation may be obtained through the following proce- dures: • a centralised procedure to obtain an authori- sation valid in all EU countries, co-ordinated by the EMA and its Committee for Medicinal Products for Human Use (CHMP), and ending with a decision by the European Commission; • a mutual recognition procedure, which allows the extension of a marketing authorisation already granted by a member state to one or more EEA countries; • a decentralised procedure, which allows a marketing authorisation to be granted simul- taneously in two or more EEA countries on the basis of identical documentation; and • a centralised procedure to obtain a marketing authorisation valid only for the French market. To initiate one of these procedures, the appli- cant must submit an application to the com- petent authority (ie, the ANSM or the EMA), together with a dossier containing the informa- tion required by EU law. The procedures for variations to the terms and conditions of a marketing authorisation are laid down in Commission Regulation (EC) No 1234/2008. These procedures differ according to the type of variation requested (variation types IA, IB and II). • Type IA variations, which have little or no impact on the quality, safety and efficacy of the medicinal product (such as the change of contact details of the marketing authorisa- tion holder) can be implemented even before being notified to the competent authorities (within 12 months of the implementation of the variation).
• Type IB variations (such as a change in the medicinal product name) must be notified by the marketing authorisation holder prior to implementation. The holder must wait 30 days to ensure that the variation is consid- ered acceptable by the competent authority (by implicit authorisation) before implement- ing the variation. • Type II variations (such as the addition of a therapeutic indication) require prior approval from the competent authority before imple- mentation. The transfer of a national marketing authorisa- tion from one holder to another is possible and subject to the approval of the ANSM. In the case of a merger or a partial transfer of assets, the companies involved may submit an applica- tion for the transfer of marketing authorisations before the merger or transfer is finally complet- ed. In support of their request, they must submit the letter of intent or agreement on the merger or contribution. Medical Devices For medical devices, these are classified into risk groups based on the risk during use, and their placing on the market requires the CE marking to be affixed to the device after the manufacturer has conducted a conformity assessment with all applicable general safety and performance requirements set out by EU law. Manufacturers of Class I medical devices and class A in vitro diagnostic medical devices (the lowest risk class) can self-certify that their devic- es meet all applicable requirements. For all other Classes (and Class I medical devices that are supplied sterile, have a measuring function or are reusable surgical instruments), the involve- ment of a notified body is required to conduct
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