GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
• approving and monitoring manufacturing facilities in order to ensure compliance with Good Manufac- turing Practices (GMP); • monitoring the quality, safety and efficacy of prod- ucts within its competency; • receiving applications for the 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 Pharmaceuticals When a marketing authorisation for a pharmaceuti- cal product is rejected, the applicant can appeal to the Committee for Medicinal Products for Human Use (under Article 49 of the JM Decision). 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 Administrative 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 oversees the marketing of medi- cal devices. This includes ensuring that these devices comply with the legal requirements outlined in the Joint Ministerial Decision DY8d/130648/2009, as amended by Ministerial Decision YA A4g/88159/2017. This framework appoints the EOF as the authority overseeing medical devices in Greece and outlines the applicability of the MDR and IVDR within the coun- try. The relevant legal provisions also include Article 2, Paragraph 2; Article 3, Paragraph 1; and Article 6, Paragraph 2 of Law 1316/1983 (Government Gazette
A’ 3/11/11.1.83), along with the applicable provisions of the MDR and IVDR. If the 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 Categories of Pharmaceuticals and Prescription-only medicines require a doctor’s pre- scription for purchase, are dispensed by pharmacies, and are subject to stricter regulations regarding their distribution and marketing. Following their approval, over-the-counter (OTC) products can be sold without a prescription but remain subject to specific pricing and distribution requirements. 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 manu- facturer; • Class IIa involves a notified body for conformity assessment; • Class IIb requires the involvement of a notified body and a more rigorous assessment (eg, clinical evaluation and performance data are required); and • Class III requires a full assessment by the notified Medical Devices Pharmaceuticals body (including a design dossier review, robust clinical data requirements and clinical trials).
2. Clinical Trials 2.1 Regulation of Clinical Trials Pharmaceuticals
The legal framework applicable to clinical trials in Greece is laid down in the Regulation (EU) No 536/2014 (“CTR”) on clinical trials on pharmaceuti- cals for human use. The provisions of the CTR were transposed into Greek law by the Joint Ministerial Decision G5a/59676/2016.
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