FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
3. Marketing Authorisations 3.1 Product Classification
decides on a five-year renewal, notably for reasons related to pharmacovigilance. • They may be revoked if the product to which it relates has not been marketed for three consecu- tive years or if the marketing of the product already placed on the market is suspended for three suc- cessive years. The ANSM may, in exceptional circumstances, grant a derogation from this rule: • for public health reasons; • when the pharmaceutical cannot legally be mar- keted during the period in question; • when the pharmaceutical is exclusively intended for export to a state that is not party to the Euro- pean Economic Area (EEA) agreement; 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 authorisation 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 dosage or pharmaceutical form of this medicinal product is marketed in France. Marketing authorisations may also be suspended 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 therapeutic results; • the risk-benefit balance is unfavourable; • the pharmaceutical does not have the declared qualitative and quantitative composition; or • the manufacturing process does not comply with the applicable good practices. Medical devices are subject to pre-market certification (CE marking), which is valid for five years. CE mark- ings can be renewed following a mandatory surveil- lance audit. Every medical 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
The classification of a product as either a pharmaceu- tical or a medical device is determined by its intended purpose and mode of action, in accordance with EU law. In essence, classifications are as follows. • A product is classified as a pharmaceutical product if it is intended to be used for medical purposes through pharmacological, immunological or meta- bolic means. This includes substances or com- binations of substances used to treat or prevent diseases, restore, correct or modify physiological functions, or make medical diagnoses. • A product is classified as a medical device if it is intended to be used for medical purposes with- out relying on pharmacological, immunological or metabolic means. Medical devices include instru- ments, apparatus, appliances, software, implants, reagents, materials or other articles used alone or in combination for medical purposes. Some products may have characteristics of both pharmaceuticals and medical devices, known as “bor- derline”, “hybrid” or even “combination” products. In such cases, the ANSM may assess the product on a case-by-case basis to determine the applicable regulatory framework. This assessment considers the product’s intended purpose, its mode of action and the claims made by the manufacturer. 3.2 Marketing Authorisation for Biologic Medicinal Products French law does not provide for specific marketing authorisation procedures for biologic medicinal prod- ucts (apart from the difference in supporting scientific data). 3.3 Period of Validity of Marketing Authorisations 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
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