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.
Joint Guidance on Virtual and Hybrid International Medical Congresses
May 2022
Authors: Irene Kyriakides, Victoria Mertikopoulou, KG Law Firm
Very recently, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) published a Joint Guidance on Virtual and Hybrid International Medical Congresses, aiming to specify the parameters and factors that Companies should consider when determining which code and/or label to use as a reference for the Company activities.
The Joint Guidance clarifies,…
Regulation on Veterinary Medicinal Products and Repealing Directive
February 2022
Life Sciences & Healthcare team at KYRIAKIDES GEORGOPOULOS Law Firm has circulated a Newsletter on the Regulation on veterinary medicinal products and repealing Directive 2001/82/EC that entered into practice on 28 January 2022 in Greece.
The goal of the Regulation is to:
Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines;
Stimulate the development of innovative veterinary medicines;
Strengthen EU action to fight antimicrobial resistance.
The report is available here.
New Law on Environmental Impact Assessment in the Pipeline: A Step Forward in Harmonisation With the EU Acquis
January 2022
Author: Milan Dakic, BDK Advokati
The Serbian Government is preparing a new Act on Environmental Impact Assessment [1] (“Draft EIA Act“) with the aim to further harmonise the existing environmental impact assessment (“EIA“) regulatory framework with that of the EU, which has been so far lagging behind the EU acquis, as well as to integrate the appropriate assessment procedure from the nature protection regulations into the EIA process.
Key novelties
EIA procedure will have to be performed before the development consent is issued
The existing EIA Act requires that the…
