FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
• Judicial appeal. This allows the regulatory decision to be challenged before the compe- tent Administrative Court. These challenge procedures also apply in gen- eral for administrative acts covering other regu- lated products (eg, food products). 1.3 Different Categories of Pharmaceuticals and Medical Devices There are multiple categories of pharmaceuticals and medical devices that are regulated differ- ently. As health products, each of their charac- teristics affects the rules applicable to them. For instance, pharmaceuticals may be subject to compulsory prescription. They require a doc- tor’s prescription to be issued. There may also be restrictions on the prescription process itself due to the level of risk of the product (eg, lim- ited to hospital settings or requiring mandatory particulars). Other pharmaceuticals may be subject to option- al prescription. They require a doctor’s prescrip- tion only to be reimbursed by statutory health insurance (SHI). Medical devices may also be subject to optional prescription for reimburse- ment purposes. In addition, there is a pharmacy monopoly on the dispensing of pharmaceuticals and certain medical devices (eg, most in vitro diagnostic medical devices). Some pharmaceuticals are offered over-the-counter, meaning that they are freely accessible by purchasers in the pharmacy, while others may only be within the pharmacist’s reach. In addition, some pharmaceuticals and medical devices may only be dispensed in hos- pital settings.
Pharmaceuticals are regulated differently depending on (i) their preparation (princeps, generic, hybrid or biosimilar pharmaceuticals) which determines the applicable marketing authorisation procedure and delivery conditions, (ii) their reimbursement status (which notably affects advertising requirements) and (iii) their therapeutic interest (pharmaceutical companies are required to maintain a minimum safety stock for products of major therapeutic interest). Medical devices are classified according to the level of risk they present for users, which is set by law. They are also subject to various rules depending on their intended use (eg, implantable or sterile) or composition (eg, software-based). Clinical trials of pharmaceuticals and medi- cal devices are regulated both by EU law and domestic rules. Clinical trials of pharmaceuticals are mainly reg- ulated by the EU Regulation on clinical trials on medicinal products for human use (Regulation 536/2014), fully applicable since January 2025. Clinical trials of medical devices, called inves- tigational studies or performance studies, are mainly regulated by the MDR and IVDR and complementing provisions of the Public Health Code. 2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical trials must also comply with domestic and international guidelines, such as the ANSM Guidelines on Good Clinical Practices, the Inter- national Conference on Harmonization Guide- lines on Good Clinical Practice or the Declara-
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