FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
• 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 pharmacovigi- lance system. The ANSM may also require the MA holder to conduct: • a post-authorisation safety study if there are concerns about the safety risks posed by an authorised product; and • a post-authorisation efficacy study when the understanding of the disease or clinical methodologies 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 com- ply 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 restric- tion imposed by the competent authority of any country in which the product is marketed and of any other new information that may influence the evaluation of the benefits and risks. Lastly, the holder must immediately inform, specifying the reasons, the ANSM of any action taken in France or in another EU member state to suspend or terminate the marketing of the medicinal product, to request the withdrawal of
the authorisation or not to apply for the renewal of the authorisation for the medicinal product. Medical Devices For medical devices, economic operators and in particular manufacturers are required to sub- mit vigilance reports to the ANSM for all the incidents of which they have become aware in France involving their devices. Manufacturers must also take appropriate safety action when required and communicate on all the corrective actions that have been undertak- en to avoid or reduce the risks associated with the use of a medical device. In addition, manufacturers of medical devices are subject to a number of obligations under the EU legislation, such as keeping the tech- nical documentation of the device up to date, appointing a person responsible for regulatory compliance and complying with vigilance report- ing obligations. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Third parties may access certain pieces of infor- mation about pending applications for marketing authorisations for pharmaceuticals and medical devices. Pharmaceuticals At the EU level, the EMA issues every month a list of “pharmaceuticals under evaluation” by the CHMP. At the national level, pending applications for marketing authorisation are not made pub- licly available. Third parties only have access to information on pharmaceuticals published by the ANSM on the database Répertoire des
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