FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
certificate from a notified body to bear the CE-marking and be placed on the French market. The notified body may narrow the scope, suspend or withdraw a certificate if the conditions for its issuance are not fulfilled or are no longer maintained. 3.4 Procedure for Obtaining a Marketing Authorisation The procedure for obtaining a marketing authorisation for pharmaceuticals and medical devices is essentially as follows. Pharmaceuticals For pharmaceuticals, a marketing authorisation may be obtained through the following procedures: • a centralised procedure to obtain an authorisa- tion 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 market- ing authorisation to be granted simultaneously in two or more EEA countries on the basis of identical documentation; and • a national procedure to obtain a marketing authori- sation valid only for the French market. To initiate one of these procedures, the applicant must submit an application to the competent authority (ie, the ANSM or the EMA), together with a dossier con- taining the information required by EU law. The procedures for variations to the terms and con- ditions 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 authorisation holder) can be imple-
mented even before being notified to the compe- tent authorities (within 12 months of the implemen- tation of the variation). • Type IB variations (such as a change in the medici- nal product name) must be notified by the market- ing authorisation holder prior to implementation. The holder must wait 30 days to ensure that the variation is considered acceptable by the com- petent authority (by implicit authorisation) before implementing the variation. • Type II variations (such as the addition of a thera- peutic indication) require prior approval from the competent authority before implementation. The transfer of a national marketing authorisation 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 application for the transfer of marketing authorisations before the merger or transfer is finally completed. In support of their request, they must sub- mit 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 devices meet all appli- cable requirements. For all other Classes (and Class I medical devices that are supplied sterile, have a measuring function or are reusable surgical instru- ments), the involvement of a notified body is required to conduct the conformity assessment and issue the corresponding certificate of conformity. In general, any variations to the approved device require a new approval by the notified body that issued the certificate of conformity, if they may affect the safety and performance of the device or the condi- tions of use prescribed for that device.
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