FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products French law does not provide for specific mar- keting authorisation procedures for biologic medicinal products (apart from the difference in supporting scientific data). 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Marketing authorisations are granted for five years for pharmaceuticals. • They may be renewed at the end of the first five years at the request of the marketing authorisation holder, for an unlimited period unless the ANSM decides on a five-year renewal, based on a reassessment of the pharmaceutical’s positive therapeutic effects in relation to the risks to patient health or public health, linked to its quality, safety or efficacy. • They may be revoked if the product to which it relates has not been marketed for three consecutive years or if the marketing of the product already placed on the market is sus- pended for three successive years. The ANSM may, in exceptional circumstances, grant a derogation from this rule: • for public health reasons; • when the pharmaceutical cannot legally be marketed during the period in question; • when the pharmaceutical is exclusively intended for export to a state that is not party to the European Economic Area (EEA) agree- ment; or • when the pharmaceutical is marketed in at least one other EU member state or party to the EEA, in which it has obtained an authori- sation pursuant to a mutual recognition
procedure or a decentralised procedure for which France is designated as the reference member state and at least one different dos- age or pharmaceutical form of this medicinal product is marketed in France. Marketing authorisations may also be sus- pended or revoked if legal requirements for the authorisations are not met or are no longer met. This includes, in particular, the following reasons: • the pharmaceutical is harmful; • the pharmaceutical does not produce thera- peutic results; • the risk-benefit balance is unfavourable; • the pharmaceutical does not have the declared qualitative and quantitative compo- sition; or • the manufacturing process does not comply with the applicable good practices. Medical devices are subject to pre-market certi- fication, which is valid for five years. Every medi- cal device must bear the CE-marking following a conformity assessment with the general safety and performance requirements set out by EU law. Lower risk devices may be self-certified but medium to high-risk devices must obtain a CE certificate from a notified body to bear the CE- marking and be placed on the French market. The notified body may narrow the scope, sus- pend 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 for Pharmaceuticals and Medical Devices The procedure for obtaining a marketing authori- sation for pharmaceuticals and medical devices is essentially as follows.
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