GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
• monitoring the quality, safety and efficacy of products within its competency; • receiving applications for pricing of pharma- ceutical products and proposing pricing to the Ministry of Health; and • approving and monitoring wholesale facilities. EOF, in the scope of its mission, is autonomous, and the Ministry of Health can only revoke its decisions based on a legally justifiable basis. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Pharmaceuticals When a marketing authorisation for a pharma- ceutical product is rejected, the applicant can appeal to the Committee for Medicinal Products for Human Use (under Article 49 of the JM Deci- sion). The Committee will issue a decision on the appeal within 60 days of the submission. If the applicant’s appeal is denied, they can further contest this decision by appealing to the Admin- istrative Court of First Instance. Additionally, objections to the price bulletin issued by the Ministry of Health can be raised through a petition for annulment submitted to the Conseil d’État (Council of State (ΣτΕ)). Objections against the decision of the Ministry of Health for non-inclusion in the Reimbursement List may be raised by a petition of annulment before the Three-Member Administrative Court of Appeal. Medical Devices In Greece, the EOF is responsible for overseeing the marketing of medical devices. This includes ensuring that these devices comply with the legal requirements outlined in the Joint Ministe- rial Decision DY8d/130648/2009, as amended
by Ministerial Decision YA A4g/88159/2017. This framework appoints the EOF as the author- ity overseeing medical devices in Greece and outlines the applicability of the MDR and IVDR within the country. The relevant legal provi- sions also include Article 2, Paragraph 2; Arti- cle 3, Paragraph 1; and Article 6, Paragraph 2 of Law 1316/1983 (Government Gazette A’ 3/11/11.1.83), along with the applicable provi- sions of the MDR and IVDR. If EOF decides to withdraw a medical device from the market, the manufacturer has the right to appeal this decision at the Administrative Court of First Instance for annulment. 1.3 Different Categories of Pharmaceuticals and Medical Devices Pharmaceuticals Prescription-only medicines require a doctor’s prescription for purchase, are dispensed by pharmacies, and are subject to stricter regula- tions regarding their distribution and marketing. Following their approval, OTC products can be sold without a prescription. Medical Devices The MDR and the Joint Ministerial Decision DY8d/130648/2009 (Article 9 and Annex IX) classify medical devices as follows: • Class I requires only self-certification by the manufacturer; • Class IIa involves a notified body for conform- ity assessment; • Class IIb requires the involvement of a noti- fied body and a more rigorous assessment (eg, clinical evaluation and performance data are required); and • Class III requires a full assessment from the notified body (including design dossier
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