GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
• the Manufacturers Incident Report (MIR) form; and • the Field Safety Corrective Action (FSCA) form. The following are reportable to EOF: (a) any malfunction or deterioration in the characteristics and/or performance of a product, as well as any deficiency in the labelling or instructions for use, which may cause or have caused the death or serious deterioration in the health of a patient; and (b) any technical or medical event relating to the characteristics or performance of a product which has led to the manufac- turer’s systematic withdrawal from the market. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Pending Applications Third parties have limited access to information in pending marketing authorisation applications. The information included in the application dos- sier (such as proprietary formulations, clinical trial data, regulatory status or information that might reveal competitive strategies) is not pub- licly accessible unless there is an overriding pub- lic interest in disclosure (Article 81, paragraph 5 of the CTR). For medical devices, no public registry of pend- ing applications exists. Granted Authorizations Pharmaceuticals The following information becomes public: • product name & active substance; • MAH; • summary of product characteristics; • public assessment report;
• approval date and therapeutic indications; and • package leaflet & labelling. Medical devices EOF may release basic registration details (eg, name of the manufacturer, general device use, approval date), but full technical documenta- tion remains confidential. Article 20 of the Joint Ministerial Decision DY8d/130648/2009 sets out what is considered non-confidential infor- mation. Moreover, the National Electronic Reg- istry of Medical Devices (GREMDIS) can only be accessed if there are dedicated credentials and is not publicly available, while for EUDAMED (the EU medical device database), in order to check for device registration/certifications, specific fields need to be completed (eg, manufacturer; notified body; certificate number and status; risk EMA publishes details of refused, withdrawn, or suspended authorisations, including the reasons for refusal. Information on national refusals (EOF decisions) is not published but can be obtained upon request. Medical devices If a CE certification is refused, the manufacturer is not obligated to disclose it. Rules on Protecting Commercially class; device type, etc). Refused Authorisations Pharmaceuticals Confidential Information and Personal Data There are confidentiality obligations regarding commercially confidential information (eg, man- ufacturing processes, regulatory strategies, pro- prietary research) and the protection of personal data (eg, clinical trial participants’ personal data and individual adverse event reports) as set out in EU legislation (eg, Regulation EU 1049/2001
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