GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
Transfer of an Authorisation Pharmaceuticals The process involves a joint transfer application to EOF, which includes: • details about the product concerned • details about the existing and the new MAH; • confirmation that there are no changes to the prod- uct; and • description of the pharmacovigilance system. Medical devices For medical devices, the rights regarding the CE marking can be transferred by: • updating the CE certificate holder details with the Notified Body; • ensuring continued compliance with the MDR and the EOF’s guidance by the new holder; and • updating EOF’s registration regarding the new owner’s details. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Pharmaceuticals Compassionate use programmes In Greece, compassionate use programmes are regulated by the Joint Ministerial Decision DYG3 (a) 85037/10/2011, which provides early access/com- passionate use of medicinal products which either constitute the subject of a marketing authorisation application before EOF or EMA or are at stage III of clinical trials and more specifically at the stage of analysis of clinical trial data. Conditions are: • approval by EOF; and • certification from a doctor of the respective speci- ality that the existing treatments do not exist. Two types of programmes may be approved: • a group early access; and • an individual early access, with a maximum duration of one year for both pro- grammes.
Every manufacturer of category IIa, IIb, and III medi- cal devices, of active implantable medical devices, as well as of in vitro diagnostic medical devices, sub- mits a technical dossier of the products to a Notified Body within the EU, which assesses their compliance with the legal requirements and issues a CE marking certificate (Article 16 and Annex XI of Joint Ministerial Decision DY8d/130648/2009, Article 9 and Annex II of Joint Ministerial Decision DY8d/130644/2009, as well as Article 9 and Annex II of Joint Ministerial Decision DY8d/3607/892/2001). Variation of an Authorisation Pharmaceuticals According to Article 43 of the JM Decision, any chang- es to an existing marketing authorisation are deter- mined by the EOF. An application providing a specific form that follows the template set by the EMA must be submitted to the EOF to initiate a variation. Variations are categorised based on their impact on safety, quality, and efficacy, and the process aligns with EU rules for minor and major variations (EU Reg- ulation 1234/2008). Minor changes may require just EOF’s notification (eg, change in labelling – such as a font size change), moderate changes require EOF’s approval before implementation (eg, change of label- ling which is linked with safety) and major changes necessitate an evaluation before implementation (eg, change in therapeutic indication, formulation). Medical devices EOF has not made publicly available a template form to be submitted for variations concerning specifically medical devices; however, based on the rules and guidance provided by EMA,the following details are expected to be requested:
• device(s) identification and classification; • name of the device and brief description; • intended purpose;
• classification; • serial number;
• manufacturer details; • notified body details; • proof of fee paid; and • details regarding the variation.
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