GREECE Trends and Developments Contributed by: Angela Livgieri and Dimitra Panopoulou, ALG Manousakis Law Firm
quality-assured supply of the population with neces- sary medicines, particularly where a therapeutic gap is identified. Significantly, in light of the precautionary principle enshrined in Article 191 of the Treaty on the Functioning of the European Union (TFEU), EOF may adopt such measures not only where shortages are proven or certain to occur, but also where there is substantiated evidence of a potential risk to the safety and quality of pharmaceutical supply. In summary, drug shortages in Greece result from a combination of: • global supply challenges; • low domestic prices; and • increased demand following the COVID-19 pan- demic. EOF’s regulatory measures, including temporary bans on parallel exports and close market monitoring, are essential to ensure patient access and prevent thera- peutic gaps. However, it must be acknowledged that a significant increase in medicine stockpiles, without adequate transparency and control in the distribution chain, will not effectively reduce shortages and may dramatically increase costs for the pharmaceutical industry. The 2025 EOF Circular: Establishing a Comprehensive Regulatory Framework for Scientific Events in Greece On 16 April 2025, EOF issued Circular No 45560/16.4.2025, together with its Corrigendum published on 21 May 2025, entitled “Circular of the National Medicines Agency on Scientific Events,” which entered into force on 1 May 2025. The Circu- lar introduces substantial revisions to the existing regulatory framework established by EOF Circular No 37201/23.03.2020, including amendments to termi- nology and updated procedural rules governing the organisation, notification and financing of scientific events, as well as the participation of healthcare pro- fessionals (HCPs) therein. It addresses pharmaceu- tical companies operating under EOF’s regulatory supervision, as well as HCPs involved in planning or attending scientific events.
Among the key developments in the 2025 Circular, the scope of products under EOF’s jurisdiction has been clarified and slightly narrowed, with cosmetic products explicitly excluded, while reaffirming most
other categories, including: • human medicinal products; • veterinary medicinal products; • foods for special medical purposes; • dietary supplements; • biocides; and • medical devices.
Notably, for veterinary medicinal products and medi- cal devices, the Circular provides that separate, dedi- cated guidance will be issued in due course, with the current Circular’s provisions to apply in the meantime. Concurrently, the definition of “scientific events” has been materially broadened. In addition to congresses, one-day and two-day conferences and seminars, the Circular now explicitly includes post-graduate training programs and webinars, as well as any form of edu- cation or training related to EOF-regulated products. These requirements remain unchanged: events must have scientific content, receive financial support from companies marketing EOF-regulated products and be organised by: • recognised public sector entities; • scientific associations; • private healthcare institutions; or • relevant companies. Additionally, the new Circular maintains the prohibition on public awareness campaigns by pharmaceutical companies under EOF’s jurisdiction regarding specif- ic formulations or products. However, the enhanced regulatory framework introduces limited exceptions and new opportunities, subject to strict conditions. Specifically, companies marketing EOF-regulated products are now permitted to organise public aware- ness events for patients and the general public con- cerning disease prevention, diagnosis and treatment, provided that a prior request is submitted through the EOF Online Application System for Scientific Confer- ences. Furthermore, companies marketing medical devices may conduct educational events aimed at instructing patients on the proper use of devices they
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