GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
4.2 Regulatory Reliance Pharmaceuticals EU-based reliance
– Access to EU Documents, 679/2016 GDPR, Regulation EU 1725/2018 for processing 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 par- agraph 9 and Directive) and conditional market- ing authorisations (Regulation 726/2004 Article 14a in conjunction with Regulation 507/2006 and Directive) for products that address unmet medical needs or serious conditions. For accel- erated assessment, the authorisation application is assessed in 150 days instead of 210 days, and the applicant submits a full set of clinical data and data proving that the medicine is of major interest to public health. Conditional marketing authorisation allows approval of the product before full submission of the clinical trial results, provided that the ben- efit of the immediate availability on the market outweighs the risk when additional data are still required. Medical Devices For medical devices, Article 11 paragraph 13 of the Joint Ministerial Decision DY8d/130648/2009 and Article 59 of the MDR provide expedited pathways in specific cases where any compe- tent authority may authorise, on a duly justified request, the placing of a specific device on the market, the use of which is in the interest of pub- lic health. EOF may grant temporary emergency use authorisation or national exemption before EU-wide approval.
If a medicine has received a marketing authori- sation from EMA, it is automatically valid in all EU member states, including Greece. If another EU national competent authority grants an authorisation via Mutual Recognition Procedure or Decentralised Procedure, EOF relies on that decision and does not reassess the application dossier. Non-EU reliance EOF may consider World Health Organization (WHO) pre-qualification medicines in case of global health emergencies. EOF does not automatically accept non-EU approvals (eg, FDA, MHRA, etc), however: • companies can submit foreign regulatory approvals as supportive data; • EOF may expedite the local review. Medical Devices If a device is already CE-certified by an EU Noti- fied Body, EOF does not conduct an additional review. Registration with EOF is still required for local market entry. In general, as per Article 20, paragraph 1 of the MDR, medical devices in con- formity with the rules of the MDR bear the CE marking of conformity, which means that they can be marketed in all member states. EOF does not automatically accept non-EU approvals (eg, FDA), but companies can submit foreign approvals to strengthen applications.
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