GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
3.7 Third-Party Access to Pending Applications for Marketing Authorisations Pending Applications Third parties have limited access to information in pending marketing authorisation applications. The information included in the application dossier (such as proprietary formulations, clinical trial data, regula- tory status or information that might reveal competi- tive strategies) is not publicly accessible unless there is an overriding public interest in disclosure (Article 81 (5) of the CTR). For medical devices, there is no public registry of pending applications. Granted Authorisations 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, the manufacturer’s name, general device use, approval date), but full technical documentation remains con- fidential. Article 20 of the Joint Ministerial Decision DY8d/130648/2009 sets out what is considered non- confidential information. Moreover, the National Elec- tronic Registry 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, such as:
Refused Authorisations Pharmaceuticals
EMA publishes details of authorisations that have been refused, withdrawn or suspended, including the reasons for refusal.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 Confidential Information and Personal Data There are confidentiality obligations regarding com- mercially confidential information (eg, manufacturing processes, regulatory strategies, proprietary 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, Reg- ulation EU 1049/2001 – Access to EU Documents, 679/2016 GDPR, Regulation EU 1725/2018 for pro- cessing of personal data by the Union institutions, bodies, offices and agencies; Directive, etc). 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Pharmaceuticals EMA provides mechanisms such as accelerated assessment (Regulation 726/2004, Article 14 (9) and the Directive) and conditional marketing authorisations (Regulation 726/2004, Article 14a, in conjunction with Regulation 507/2006 and the Directive) for products that address unmet medical needs or serious condi- tions. For accelerated assessment, the authorisation application is assessed within 150 days instead of 210 days and the applicant submits a full set of clinical data and evidence that the medicine is of major inter- est to public health. Conditional marketing authorisation allows approval of the product before full submission of the clinical trial results, provided that the benefit of immediate market availability outweighs the risk when additional data are still required.
• manufacturer; • notified body; • certificate number and status; • risk class; • device type.
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