The New Medical Devices Act in Serbia

BDK Attorney at Law Bisera Andrijasevic provides an overview of the implication of the new Medical Devices Act in Serbia. The new Medical Devices Act, which had entered into force already on 1 December 2017, became applicable on 1 December 2018. The adoption of this legislation marks the beginning of distinct legal treatment of medical devices, separate from the treatment of medicinal products which remain regulated by the old Medicines and Medical Devices Act.

BDK Advokati on Legal Practice for the Life Sciences Industry in Serbia

Bogdan Ivanisevic, partner, and Bisera Andrijasevic, associate, authored the Serbian chapter in the 2019 edition of Getting the Deal Through – Life Sciences 2019.

BDK Advokati Advises Industriaimport-Industriaimpex AD

BDK Advokati advised Montenegrin publicly listed company Industriaimport-Industriaimpex AD on the acquisition of 49% of registered capital of Serbian pharma wholesaler Farmalogist d.o.o. from PE firm Adriatic Fund B.V. BDK Advokati also assisted Industriaimport-Industriaimpex AD in connection with the Shareholders’ Agreement entered with the owners of the remaining 51% of shares in Farmalogist. The acquisition was completed on 4 January 2019 upon obtaining merger clearances from the Montenegrin and Serbian competition authorities. Partner Vladimir Dasic was the main legal advisor to Industriaimport-Industriaimpex…

The Clawback of the ‘New Generation’ Growth Share Criterion and Case Law

The clawback mechanism has been initially established as an emergency measure but as indicated by the Greek case law, it is here to stay. In their article available for download, KG Law Firm talks about the Council of the State ruling on the clawback mechanism and the addition of the growth share criterion.  

Drug Distribution: Recent Greek Court Developments

Representative rulings: Single Member Court of Athens 2837/2018 & 6001/2018 The highlights of the recent Greek jurisprudence in relation to drug distribution:Marketing Authorization Holders ("MAH") can freely organize/restructure their distribution network. The nature of medicinal products does not dictate an obligation of the MAH to cooperate with every active wholesaler in the region. The public service obligation entrusted with the MAH and drug wholesalers is considered fulfilled, as long as the market as sufficiently supplied. A drug distribution contract, once terminated, cannot…

Medicinal Cannabis in Greece

The cannabis revolution, worldwide spread, has recently reached Greece, the latter introducing Law 4523/2018 pertaining to the authorization of the cultivation, production and trade of medicinal cannabis in Greece. Nine months upon publication of the said Law in the Governmental Gazette,  first two licenses for growing of medicinal cannabis were granted. The growing investing interest, emanating mainly from Canada and Israel, is expected to amount approximately to EUR 200 million  and has been welcomed by the Greek Government which strives to create a more flexible and attractive entrepreneurial…

NNDKP Represented the Baylor Marea Neagra Foundation Successfully in a Court Dispute

The Romanian fiscal bodies refused to authorize the VAT-exempt import of the medicines necessary for treating several serious conditions, including HIV/AIDS infection, anaemia caused by chronic renal diseases and certain types of cancer. The refusal to authorize the VAT-exempt import was issued for a donation of medicines, in the total amount of USD 3,157,984.50, imported by the Baylor Foundation to be distributed freely to patients in the state hospital network that is experiencing financial distress. “Among the years, thanks to the partnerships developed by the Baylor Foundation with American…

Polenak Law Firm Advised Diaverum

Polenak Law Firm advised Diaverum in the acquisition of dialysis services provider in Macedonia. Diaverum enters the Macedonian market through the acquisition of PZU Diamed Macedonia. PZU Diamed Macedonia operates nine dialysis centres since 2014, after being awarded one of two lots in a national public tender. The tender has a duration of 20 years and will last until 2034. More information is available at

New Fees for Pharma Companies in Greece

On 2 August 2018, a new Greek Ministerial Decision was issued, namely No. 58584/02.08.2018, following the establishment of the Health Technology Assessment ("HTA") Committee for the assessment of medicinal products by virtue of L.4512/2018. The aforementioned Decision determines the applicable fees that must be paid by the Pharmaceutical Companies in order for their products to be evaluated by the abovementioned Committee for the purpose of their compensation by the State. According to its provisions, all Marketing Authorization Holders that will apply for the assessment of their products by the…

Updated Chapter “Life Sciences: Product Regulation and Liability in Greece" Published

In cooperation with Lexology and as exclusive contributors for Greece, KG Law Firm has recently launched the updated chapter “Life Sciences: Product Regulation and Liability in Greece”. In it, authors Irene Kyriakides and Nefelie Charalabopoulou examine the Greek authorities’ introduction of health technology assessments to the pharmaceutical sector as a way of assessing the interaction between science and technology in healthcare and disease prevention by July 2018. Read “Life Sciences: Product Regulation and Liability in Greece”.