FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
( recours hiérarchique ). This administrative appeal is a complaint addressed to the authorities ask- ing them to change a decision they have taken, whether explicitly (eg, refusal) or implicitly (eg, lack of reply). In certain cases, this appeal may be com- pulsory prior to lodging a judicial claim. • Judicial appeal – this allows the regulatory decision to be challenged before the competent Administra- tive Court. These challenge procedures also apply in general for administrative acts covering other regulated products (eg, food products). 1.3 Categories of Pharmaceuticals and Medical Devices There are multiple categories of pharmaceuticals and medical devices that are regulated differently. As health products, each of their characteristics affects the rules applicable to them. For instance, pharmaceuticals may be subject to compulsory prescription. They require a doctor’s pre- scription to be issued. There may also be restrictions on the prescription process itself due to the level of risk of the product (eg, limited to hospital settings or requiring mandatory particulars). Other pharmaceuticals may be subject to optional prescription. They require a doctor’s prescription only to be reimbursed by statutory health insurance (SHI). Medical devices may also be subject to optional pre- scription for reimbursement 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 pharmaceuti- cals and medical devices may only be dispensed in hospital settings. Pharmaceuticals are regulated differently depend- ing 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 compa- nies are required to strengthen minimum safety stock levels 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 composi- tion (eg, software-based). Clinical trials of pharmaceuticals and medical devices are regulated both by EU law and domestic rules. Clinical trials of pharmaceuticals are mainly regulated by the EU Regulation on clinical trials on medicinal products for human use (Regulation 536/2014), fully applicable since January 2025, which harmonises the process for the assessment and supervision of clinical trials throughout the EU. Clinical trials of medical devices, called investigational 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 International Confer- ence on Harmonization Guidelines on Good Clinical Practice or the Declaration of Helsinki on Ethical Prin- ciples for Medical Research Involving Human Sub- jects. 2.2 Securing Authorisation to Undertake a Clinical Trial The procedure for securing authorisation to under- take a clinical trial of a pharmaceutical and a medical device is essentially as follows. Pharmaceuticals For pharmaceuticals, applications to run a clinical trial must be submitted to the ANSM via the Clinical
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