FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
3.6 Ongoing Obligations Imposed by Marketing Authorisations
EU regulations do not provide for the transfer of the CE marking. The new manufacturer of the medical device must fulfil all the necessary requirements to obtain certification for the device under their own name. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The supply to patients of pharmaceuticals and medical devices that are not subject to a marketing authorisa- tion is generally not permitted, unless they are a can- didate in a clinical trial. However, derogations apply. Pharmaceuticals For pharmaceuticals, there are two main derogatory pathways: • early access ( accès précoce ) for pharmaceuticals intended to treat serious, rare or disabling diseases when the following conditions are met: (a) the product addresses an unmet therapeutic need; (b) the product is presumed to be innovative; (c) the treatment cannot be delayed; and (d) the efficacy and safety of the product in the envisioned indication is strongly presumed in view of the results of therapeutic trials; • compassionate use ( accès compassionnel ) for pharmaceuticals in specific therapeutic indications when the following conditions are met: (a) the product is not the subject of research involving human subjects for commercial pur- poses; (b) there is no appropriate treatment; and (c) the efficacy and safety of the product are presumed with regards to the available clinical data. Medical Devices For medical devices, the ANSM may authorise, by way of exception, the placing on the French market of a device which does not bear the CE marking, but whose use is in the interest of public health or in the interest of patient safety or health. Some derogatory pathways exist to facilitate access by patients to inno- vative devices (eg, Forfait Innovation).
Marketing authorisation (or CE-marking) holders are bound by strict post-market surveillance obligations. Pharmaceuticals For pharmaceuticals, marketing authorisation hold- ers must conduct pharmacovigilance by recording suspected adverse reactions in detail and reporting those classified as serious with the highest degree of urgency. This information must be collected and sub- mitted to competent authorities in the form of periodic safety update reports. The holder is also required to implement a pharma- covigilance system and, in particular, to: • respect the good practices on pharmacovigilance; • have an adequate pharmacovigilance system and a risk management system; • have a suitably qualified person responsible for pharmacovigilance in both the EU and France; • monitor the results of risk mitigation activities; • monitor pharmacovigilance data; and • conduct periodic audits of the pharmacovigilance system. The ANSM may also require the MA holder to conduct: • a post-authorisation safety study if there are con- cerns about the safety risks posed by an author- ised product; and • a post-authorisation efficacy study when the understanding of the disease or clinical methodolo- gies indicate that previous efficacy assessments may need to be significantly revised. More generally, the holder must contribute to the product’s proper use, in particular by ensuring that it is prescribed in accordance with its MA. In the event of prescriptions that do not comply with proper use, it must take all appropriate measures to inform health professionals and immediately inform the ANSM. The holder is further required to inform the ANSM immediately of any prohibition or restriction imposed by the competent authority of any country in which the product is marketed and of any other new information
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