FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
the conformity assessment and issue the cor- responding certificate of conformity. In general, any variations to the approved device require a new approval by the notified body that issued the certificate of conformity, if they may affect the safety and performance of the device or the conditions of use prescribed for that device. EU regulations do not provide for the trans- fer of the CE marking. The new manufacturer of the medical device must fulfil all the neces- sary 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 mar- keting authorisation is generally not permitted, unless they are a candidate in a clinical trial. However, derogations apply. Pharmaceuticals For pharmaceuticals, there are two main deroga- tory pathways: • early access ( accès précoce ) for pharmaceu- ticals intended to treat serious, rare or disa- bling diseases when the following conditions are met: (a) the product addresses an unmet thera- peutic need; (b) the product is presumed to be innovative; (c) the treatment cannot be delayed; and (d) the efficacy and safety of the product 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 purposes; (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 pub- lic health or in the interest of patient safety or health. Some derogatory pathways exist to facil- itate access by patients to innovative devices (eg, Forfait Innovation ). 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Marketing authorisation (or CE-marking) hold- ers are bound by strict post-market surveillance obligations. Pharmaceuticals For pharmaceuticals, marketing authorisation holders 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 submitted to competent authorities in the form of periodic safety update reports. The holder is also required to implement a phar- macovigilance system and, in particular, to: • respect the good practices on pharmacovigi- lance;
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