GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
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 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 Compassionate use programmes: In Greece, compassionate use programmes are regu- lated by the Joint Ministerial Decision DYG3(a) 85037/10/2011, which provides early access/ compassionate 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 specifi- cally at the stage of analysis of clinical trial data. Conditions are: • approval by EOF; and • certification from a doctor of the respective speciality 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 programmes. Authorisations Pharmaceuticals In the first case, the applicant is the applicant for the marketing authorisation before the compe- tent authority or the sponsor of the clinical trial,
Variations are categorised based on their impact on safety, quality, and efficacy, and the process aligns with EU rules for minor and major varia- tions (EU Regulation 1234/2008). Minor changes may require just EOF’s notification (eg, change in labelling – such as a font size change), mod- erate changes require EOF’s approval before implementation (eg, change of labelling which is linked with safety), 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; • manufacturer details; • notified body details; • proof of fee paid; and • details regarding the variation. 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 product; and • description of the pharmacovigilance system. • classification; • serial number;
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