Joint Ministerial Decision for the Simplification of Clinical Research Issued: Overview of Key Changes in Clinical Research Contracting in Greece
February 2026
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, Aithra-Valentina Antoniadou, Associate and Christos Christodoulou, Associate
Kyriakides Georgopoulos Law Firm
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…
New MD on Individual Distribution of High-Cost Medicines: What It Really Changes
December 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, and Christos Christodoulou, Associate
Kyriakides Georgopoulos Law Firm
On November 27, 2025, Ministerial Decision EALE/G.P. oik. 51724/2025 (Government Gazette B 6333/27.11.2025 – the “MD”) was issued, setting out updates to the framework governing the individual distribution of High-Cost Medicines (FYK, per their Greek acronym) procured by the National Organisation for Health Care Services (EOPYY) and dispensed through private pharmacies as the final delivery point.
Crucially, the MD does not introduce full liberalisation…
Unique Device Identifier
November 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, and Aithra Valentina Antoniadou, Associate
Kyriakides Georgopoulos Law Firm
The National Organization for Medicines (“EOF”, as per its Greek initials) published on Thursday, 13 November, 2025, an announcement on the unique device identifier (“UDI”) system provided for in the Regulation (EU) 2017/745 on medical devices and of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
UDI is a series of numeric or alphanumeric characters created through internationally accepted device identification and…
New Circular on Scientific Events
April 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, and Aithra Valentina Antoniadou, Associate
Kyriakides Georgopoulos Law Firm
On April 16th, 2025, the National Organization for Medicines (“EOF” as per its Greek acronym) issued and published on its website the highly anticipated new Circular on scientific events under prot. no. 45560/16.04.2025. The new Circular amends the relevant regulatory framework and provides for an exhaustive list of scientific events categories and restrictions. The most noteworthy provisions are summarised as follows.
Specific periods of…
NNDKP Assisted MedLife in Increasing its Syndicated Loan by EUR 50 Million
April 2025
Our member firm Nestor Nestor Diculescu Kingston Petersen (NNDKP) assisted MedLife, the largest private healthcare network in Romania and the only company with Romanian capital listed on the Stock Exchange, in increasing its syndicated loan by up to EUR 50 million, thus reaching a total of EUR 330 million.
The syndicate of banks that granted the loan includes Banca Comercială Română (BCR), Raiffeisen Bank, BRD Groupe Société Générale, Banca Transilvania and ING Bank N.V. Amsterdam Bucharest Branch.
MedLife will use the new funds to complete its ongoing projects and to continue…
New Framework in Greece to Combat Falsified Medicines and Protect Public Health
March 2025
Irene Kyriakides, Partner, Victoria Mertikopoulou, Partner, Aithra Antoniadou, Associate, and Anastasia Iliopoulou, Associate
Kyriakides Georgopoulos Law Firm
Background
The rise of falsified medicines in the European Union presents a serious threat to public health. These counterfeit drugs may have incorrect packaging, labeling, or ingredients — or even falsified distribution records making their way into the market not just through illegal channels but also within the legal supply chain.
To enhance safeguards, the EU introduced Commission Delegated Regulation (EU) 2016/161…
Kyriakides Georgopoulos Law Firm Acted as Greek Legal Advisor to Becton, Dickinson and Company
November 2024
Our member firm, Kyriakides Georgopoulos Law Firm, acted as Greek legal advisor to Becton, Dickinson and Company ("BD"), a leading global medical technology company, in the local acquisition of the Critical Care business of Edwards Lifesciences. This transaction was completed as part of BD’s USD 4.2 billion global acquisition of Edwards Lifesciences' Critical Care product group, a global leader in advanced monitoring solutions. The deal unlocks new opportunities for value creation and enhances BD's portfolio of smart, connected care solutions.
The KG Law Firm project team was…
BOYANOV & Co. Represents Generali in the Acquisition of United Health Insurance Fund Doverie
August 2024
BOYANOV & Co. has announced that it has successfully represented Generali CEE Holding in acquiring United Health Insurance Fund Doverie, one of Bulgaria’s largest health insurance providers. This strategic acquisition marks a significant milestone in Generali’s expansion within the Bulgarian market.
The deal, announced on 1 August 2024, underscores Generali’s commitment to enhancing its presence in the health insurance sector and providing comprehensive healthcare solutions to its clients. BOYANOV & Co.’s legal expertise and dedication were instrumental in navigating…
The Government of Serbia Repealed Most of the Recent Restrictions on Clinical Trials
October 2023
As SEE Legal reported, in August this year, the Government of Serbia adopted amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), introducing significant changes to the clinical trials regime.
The first amendment limited clinical trials to public healthcare institutions, excluding privately-owned healthcare institutions from the clinical trials system. The second amendment completely excluded the possibility of conducting phase I clinical trials (phase I, Ia, and Ib) in Serbia.
The amendments caused backlash from the industry associations,…
New Restrictions to Clinical Trials in Serbia
August 2023
The Government of Serbia adopted in the beginning of August amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), which entered into force on 12 August 2023. There are two significant changes that negatively affect clinical trials in Serbia.
The first amendment relates to the site of a clinical trial, which is now limited to public healthcare institutions. Therefore, clinical trials can no longer be conducted in privately owned healthcare institutions.
The second amendment excludes phase I clinical trials (phase I, Ia, and Ib) from…
Medicines Manufacturer Antibiotice Iasi Plans to Invest EUR 40 million in two New Factories
August 2022
Medicines manufacturer Antibiotice Iasi plans to invest EUR 40 million in two new factories that could produce "made in Romania" sterile products and sterile topical products. Antibiotice has invested in the development of its portfolio in the export area in the past few years, and it plans to open a new production unit dedicated to ointments and topical products, a EUR 25 million investment, in the autumn of 2022.
KG Law Firm Proud contributors to the Pharmaceutical Advertising 2022 Guide by ICLG
KG LawFirm has shared the latest International Comparative Legal Guide – Pharmaceutical Advertising and Regulations 2022, published by Global Legal Group.
The Greek chapter authored by KG Law Firm’s Life Science & Healthcare team covers important issues in pharmaceutical advertising laws and regulations, including promotion of prescription-only medicines to healthcare professionals, prohibition of gifts, events and hospitality, donations, advertisement of non-prescription medicines, and transparency and disclosure.
The chapter is available here.
