On January 22, 2026, Joint Ministerial Decision D3(a) 52922/2026 (Government Gazette B’ 230/22.01.2026 – the “JMD”) was issued, reforming the contractual and financial framework for clinical trials and clinical research involving medicinal products and medical devices in Greece.
The new JMD introduces a unified operational framework governing the contracting, signature process and financial management of a broad range of clinical trials and clinical research activities in Greece. Its overarching aim is to reduce administrative complexity, standardize documentation and impose predictable timelines across institutions and study types.
The JMD applies to:
- interventional clinical trials with medicinal products (including low- intervention trials),
- non-interventional studies with medicinal products,
- clinical investigations of medical devices and performance studies of in vitro diagnostic devices conducted within and outside their intended use, and
- certain categories of research without medicinal products or devices.
Key procedural and contractual takeaways
- Introduction of mandatory standardized templates
A core element of the JMD is the update of the existing mandatory template for clinical trial agreements, together with the introduction of mandatory national templates for the contracting of other clinical research activities. Specifically:
- template agreements tailored to each study type (interventional clinical trials, non-interventional studies, clinical investigation with medical devices and clinical performance of in vitro diagnostic products, whether conducted within or outside their intended use), and
- updated standard annexes covering, inter alia, investigators’ team composition, budget structure and acceptance of financial management.
The templates are binding across public and private sites; therefore, such standardization is expected to significantly reduce negotiation cycles and site-specific contractual practices.
- Streamlined contracting process and defined timelines
The JMD formalizes the contracting workflow through clear procedural steps and binding deadlines for all involved bodies, with the aim of accelerating contract execution.
In particular:
- contract preparation and review by the study center and financial management bodies may proceed in parallel with regulatory, ethical or scientific review of the trials/studies by the National Organization for Medicines (EOF), reducing idle time between approvals and signature;
- the role of the Autonomous Clinical Trials Department (ATKM) (or, where not established, the relevant administrative secretariat) is reinforced as the primary coordination point at site level;
- fixed deadlines are introduced for institutional signatures (typically ranging from 5 to 8 working days per step), significantly shortening the “time to signature”;
- in specific cases, tacit positive opinions by Scientific Councils or Committees are recognized if no response is issued within the prescribed deadline;
- the JMD establishes a new administrative procedure, registered in the National Registry of Administrative Procedures (EMDD) “Mitos”, governing the execution of contracts for clinical trials, non-interventional studies with medicinal products, clinical research and performance studies with medical devices, as well as for the related financial management; and
- explicit provisions address unjustified delays by introducing accountability mechanisms applicable to the administrators and competent bodies of public institutions involved in the contracting and financial management process, including disciplinary consequences for failure to comply with the statutory timelines.
- Clarification on permissible study settings
Without altering the applicable approval requirements, the JMD clarifies that certain non-interventional studies with medicinal products, as well as clinical investigations and performance studies of medical devices and in vitro diagnostic products conducted within their intended use, may be carried out outside the hospital environment, including in primary care or other outpatient settings.
- Financial management and traceability
The JMD also clarifies and standardizes key aspects of financial execution:
- each research activity is assigned a unique reference code, to be used consistently for billing, invoicing and internal tracking of protocol-related procedures;
- the respective roles of ELKE / ELKEA and the hosting institution are clearly defined, even in cases where no financial management applies (e.g. zero-fee studies);
- rules on cost allocation, invoicing and payment flows are harmonized across research activities, improving predictability for sponsors and sites; and
- for interventional trials, the framework clarifies pathways for the ordering and reimbursement of investigational and related products via site pharmacies.
- Electronic submission and execution of documents
The new regime allows for the electronic submission of the contracting dossier and the execution of contracts using qualified electronic signatures in accordance with the eIDAS Regulation.
- Entry into force and transitional arragements
The JMD applies form its pubication in the Government Gazzete. Transitional provisions address pending on ongoing studies, allowing them to be completed under the previous regime, subject to the conditions set out in the JMD.
Key Practical Considerations
- Lock in the correct template and process early: Confirm the applicable JMD template set and procedural track at study kick-off (CTA vs non-interventional vs device/IVD), and structure contracts, budgets and annexes accordingly from the first draft.
- Work backwards from the new statutory timelines: Organize internal and external circulation (ATKM, site administration, ELKE/ELKEA) in advance so that the 5–8 working-day signature windows can be met without re-routing or re-submission.
- Build traceability and digital execution into day one: Use electronic submission and e-signatures as standard practice and ensure the study reference code is embedded across all financial and invoicing workflows.