GREECE Trends and Developments Contributed by: Angela Livgieri and Dimitra Panopoulou, ALG Manousakis Law Firm
overall responsibility for regulatory compliance, safety, data integrity and insurance/indemnification. Clinical investigations may only be conducted following the execution and submission of a standardised written contract using the mandatory templates annexed to the Decision. Where relevant, a centralised administrative pathway has been established via the Autonomous Clinical Trials Department (ATKM) and the National Regis- ter of Administrative Procedures (EMDD) “Mitos.” Under this framework, submissions are channelled through ATKM’s portal or the administration secretar- iat, with expedited handoffs to the Special Account for Research Funds (ELKE) and the Special Account for Research Funds of Higher Education Institutions (ELKEA) according to fixed deadlines. Such stream- lined procedures were not available under the previ- ous regulatory framework. Standard agreement templates now incorporate embedded compliance measures, integrating refer- ences to International Council for Harmonisation – Good Clinical Practice (ICH-GCP) principles and eth- ics norms. In the case of non-interventional research, templates reference the Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) principles. This ensures greater con- sistency in obligations and oversight, which was absent from the previous regime. It is also worth not- ing that the Decision, for the first time in Greek clini- cal trial regulation, formally authorises and facilitates digitisation and the use of electronic signatures across the contract dossier. A notable innovation under the current framework is the codification of precise and explicit timelines for institutional signatures, including, by way of exam- ple, five or eight working days at various procedural steps, and the recognition of tacit positive opinions from Scientific Councils where applicable, thereby effectively shortening the time to contract execution. Moreover, under the Decision, each contracted pro- ject or site is assigned a unique reference code for all protocol-required procedures, providing a clear basis for internal coordination and billing. Financial roles are now more precisely defined, with ELKE/ELKEA’s review and signature responsibilities explicitly speci-
fied, including invoicing details, while ELKE/ELKEA’s signature is not required for zero-budget studies. Importantly, enhanced accountability measures have been introduced, with explicit disciplinary provisions applying to unjustified delays in contracting or finan- cial management. In conclusion, building on the 2016 regime, the new framework standardises clinical trial contracts, dig- itises submissions and signatures and establishes clearer timelines and accountability for approvals and financial management. It does not merely align Greece with Regulation (EU) No 536/2014; it fully operation- alises and implements it. Unlike the 2016 framework, which focused on roles and governance structures, the Decision transforms the system, from policy into measurable performance through:
• faster contracting; • clearer budgeting; • smoother site activation; and • predictable timelines.
As a result, Greece is positioning itself as a more com- petitive, efficient and sponsor-friendly clinical research hub in Europe, offering pharmaceutical companies reduced administrative burden, faster study start-up, better cost control and improved reliability. Drug Shortages and Parallel Exports in Greece in the Post-COVID-19 Era: The Regulatory Role of the EOF and the Case Law of the Conseil d’ Etat Drug shortages constitute a widespread challenge across Europe and globally, further intensified in the aftermath of the COVID-19 pandemic. The principal global causes include shortages of raw materials and active pharmaceutical ingredients (APIs), supply chain disruptions and increased seasonal demand, affecting widely used medicines containing active substanc- es such as paracetamol, amoxicillin and respiratory inhalers. Greece occupies a relatively favourable position com- pared to many EU Member States due to robust local production of off-patent medicines by approximately 50 domestic manufacturing facilities. Nevertheless, shortages persist, particularly for patented medicines. A major contributing factor is Greece’s comparatively
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