Security Alert
Introducing a regulatory briefing focused on legislative developments shaping the pharmaceutical products and medical devices landscape in Greece, providing timely insight into changes of practical relevance for life sciences stakeholders.
This edition highlights recent ministerial and joint ministerial decisions, as well as EOPYY measures, with concise, actionable takeaways for pharmaceutical manufacturers, MAHs, and MedTech suppliers.
Clawback settlement instalments for 2024 debts
Ministerial Decision Δ3(α) 45421/02.12.2025; (GG B’ 6697/15.12.2025), as corrected by GG B’ 7040/24.12.2025
MAHs and pharmaceutical companies may settle 2024 clawback debts to EOPYY through an instalment arrangement, provided there are no outstanding rebate obligations for 2024 under Article 35 of Law 3918/2011 and that instalments under prior arrangements (for 2012–2018 and 2019–2023) are duly paid.
Application deadline to EOPYY’s Directorate of Financial Services is 15 January 2026 (correction from the previously misstated 15 October 2026).
If eligibility conditions are met within six months after the deadline, inclusion remains possible, provided the first instalment covers all instalments due from 28 February 2026 through the month the schedule begins.
Debts included in the arrangement are exempt from surcharges, additional taxes, interest, and penalties; the debtor benefits by analogy from Article 11 of Law 4321/2015 upon voluntary payment of the first instalment.
Inclusion results in an EOPYY debt-clearance certificate and suspension of enforcement against assets, except for already imposed third-party garnishments or where orders have been issued; amounts collected under such measures are credited to the arrangement if not allocated to other unregulated debts.
Loss of the arrangement occurs upon late or missed payment of any instalment or current EOPYY obligation; outstanding debts become overdue and collectable under public revenue rules, and the MAH’s products are delisted from the Reimbursement List under Article 12 of Law 3816/2010 by Ministerial decision.
Instalments may be paid via direct debit upon application to a collection entity; no further surcharges or late interest apply to included debts.
To access the full text in its original form, click here, and to view the correction regarding the date for the submission of the application, click here.
List of pharmaceutical products for serious disease treatment updated
Ministerial Decision Δ3(α) 49131/08.12.2025; GG B’ 6713/15.12.2025
The list for the pharmaceutical products regarding the treatment of serious diseases under Article 12(2) of Law 3816/2010 is revised.
To access the full text of the M.D. and the respective list, click here.
Amendments to the medicine pricing framework
Ministerial Decision Δ3(α) 53191/22.12.2025; GG B’ 7194/31.12.2025
Key changes include:
For the first time, a MAH must submit, following its pricing application, a certificate confirming its ability to supply the Greek market immediately upon receiving a price.
For new medicines with an estimated retail price ≤ €10, the MAH may choose classification of the product as reimbursable or non‑reimbursable. Those pricing requests from now on shall be addressed directly to the Committee for the Evaluation and Reimbursement of Medicines for Human Use without a separate opinion from EOF’s Pricing Department being provided.
Reimbursable medicines may request category change to non‑reimbursable; if the criteria are met, an ex‑factory price increase shall be applicable without the prior 15% cap and without the previous €10 retail price ceiling. The resulting ex-factory price may not exceed the average of the two lowest prices in the Eurozone (or one country if marketed in only one); it is made explicit that the 15% cap increase and the €10 cap do not apply to generics anymore.
Although non‑reimbursable medicines are not repriced through the annual Revised Medicines Price List, companies may request for a price revision from EOF’s Pricing Department; any ex‑factory price increase is no longer capped at 15%, but the Eurozone “two‑lowest average” ceiling applies; generics are specifically exempted from the 15%/€10 limitations.
The provision for simultaneous publication on EOF’s website alongside new medicine prices is deleted, which does not enhance transparency in price changes.
To access the full text of the amended articles of the M.D., click here.
Clawback offsetting expanded to MoH Sectoral Development Program funds
Joint M.D. B1β,Β2α,β/οικ.58170/23.12.2025; GG B’ 7056/24.12.2025
Amounts allocated under the Ministry of Health’s Sectoral Development Program are now included in clawback offsetting for R&D spending and investment projects for 2024–2025.
To access the full text of the Joint M.D., click here.
Allocation of clawback-related expenditure limit increases for 2024
Joint M.D. B1β,Β2α,β/οικ.57023/18.12.2025; GG B’ 6960/22.12.2025
Finalised allocation under Article 25(3)(c) of Law 4549/2018: €60m to EOPYY community pharmaceutical expenditure (from €1.287bn to €1.347bn), €85m to EOPYY pharmacy pharmaceutical expenditure (from €900m to €985m), and €155m to NHS hospital pharmaceutical expenditure (from €553m to €708m).
Any differences from prior temporary allocations will be offset and confirmed through new clawback imposition notes within the current year; there are no changes versus the latest temporary increase.
Τo access the full text of the Joint M.D., click here.
Reimbursement indications for radiotherapy procedures
EOPYY Board Decision 1062/360; GG B’ 6597/09.12.2025
An Annex to Article 23(2a)–(2b) of Joint M.D. EΑΛΕ/Γ.Π. 4091/24.04.2025 specifies medical indications for reimbursement of IMRT, CNS stereotactic radiosurgery/radiotherapy (SRS/SART), and body SBRT at contracted hospitals and private clinics. To view the Annex, click here.
EOPYY will issue circulars with clarifying instructions and required documentation for all categories, including medical reports, hospitalisation invoices, diagnostic results, and data from the radiotherapy treatment plan.
EOPYY budget health services, medical devices, and dietary supplements
Joint M.D. ΕΑΛΕ/Γ.Π. 58662/29.12.2025; GG B’ 7214/31.12.2025
The permissible expenditure limits for EOPYY in 2025 covering health services, medical devices, and dietary supplements are set on a semi‑annual basis and may be viewed by clicking here.
Weighted Average Smoothing Index tables amended
Ministerial Decision ΕΑΛΕ/Γ.Π.οικ. 55907/11.12.2025; GG B’ 6949/22.12.2025
Table A1 of Annex A and Table B1 of Annex B to M.D. ΕΑΛΕ/Γ.Π. 38587/31.07.2024 (as corrected by B’ 4887) are amended for the application of the Weighted Average Smoothing Index under Article 100(4A) of Law 4172/2013 may be viewed by clicking here.
Transfer of value disclosures of Law 4316/2014 for FY 2025
Pursuant to Article 66(7) of Law 4316/2014 (A' 27) regarding the obligation to disclose transfers of value, any request for the organisation of a scientific event, expert committee, and participation of HCPs, submitted through the EOF's Online Application for Scientific Conferences and taking place in 2025, has a reporting deadline of 30 June 2026, for companies with products under EOF's jurisdiction and for Scientific Healthcare Bodies, so that the disclosure of this information can follow.
The relevant EOF announcement may be found here.
Mandatory use of the European Database for medical devices (Eudamed)
The mandatory use of the four modules of the European Database for Medical Devices (Eudamed) that meet the operational specifications will begin on 28 May2026.
According to Decision (EU) 2025/2371, the following electronic systems included in the European Database for Medical Devices (Eudamed) are operational and meet the operational specifications:
the electronic system for registration of economic operators, referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746;
the UDI Database and the electronic system for registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746;
the electronic system for Notified Bodies and certificates, referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746;
the electronic system for market surveillance, referred to in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.
The relevant EOF announcement may be found here.
Key takeaways
The recent regulatory measures confirm a continued focus on expenditure control, pricing flexibility, and procedural compliance across the pharmaceutical and medical devices sectors. Of immediate relevance are the new clawback instalment options for 2024 debts, amendments to the pricing framework affecting both reimbursable and non-reimbursable medicines, and the expansion of clawback offsetting mechanisms. Stakeholders should also prepare for upcoming compliance milestones, including enhanced disclosure obligations and the mandatory use of Eudamed in 2026.