FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
that may influence the evaluation of the benefits and risks. Lastly, the holder must immediately inform, speci- fying 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 For medical devices, economic operators and in par- ticular manufacturers are required to submit 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 cor- rective actions that have been undertaken to avoid or reduce the risks associated with the use of a medical device. In addition, manufacturers of medical devices are sub- ject to a number of obligations under the EU legisla- tion, such as keeping the technical documentation of the device up to date, appointing a person responsible for regulatory compliance and complying with vigi- lance reporting obligations. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Third parties may access certain pieces of information about pending applications for marketing authorisa- tions for pharmaceuticals and medical devices. Pharmaceuticals medicinal product. Medical Devices 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 mar- keting authorisation are not made publicly available. Third parties only have access to information on phar- maceuticals published by the ANSM on the database Répertoire des spécialités pharmaceutiques and the relevant documents (ie, the summary of product char- acteristics and the patient information leaflet). Oth- erwise, the ANSM publishes the summary report of
the assessment carried out for each new medicinal product as well as the decisions to grant, suspend or withdraw marketing authorisation. The ANSM also publishes the agendas and minutes, with details and explanations of votes (including minority opinions), of the meetings of its commissions, committees and expert collegial bodies, excluding any information covered by business or medical secrecy. Medical Devices For medical devices, information may be publicly accessed via EUDAMED, which is currently being deployed by gradual roll-out. Once fully functional, EUDAMED will ultimately be composed of six mod- ules: • actor module; • unique device identification (UDI) and device mod- ule; • notified bodies and certificates module; • market surveillance module; • vigilance and post-market surveillance and vigi- lance module; and • clinical investigations and performance studies module. The European Commission has declared that the first four EUDAMED modules are now functional and com- ply with the specifications laid down by Regulation (EU) 2017/745 on medical devices. The other two will be put into service at a later date. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The French regulatory framework does not specifi- cally foresee fast-track registration routes for phar- maceuticals and medical devices. Only pharmaceuti- cals subject to the centralised procedure (at EU level) may benefit from accelerated assessment, namely those of major public health interest, particularly from the point of view of therapeutic innovation or those addressing diseases with an unmet medical need. Pharmaceuticals can also be granted a conditional marketing authorisation under specific criteria, which corresponds to a fast-track approval procedure. This
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