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Bisera Andrijašević, Lexology GTDT – Pharma & Medical Device Regulation 2024 – Serbia

BDK Advokati’s Head of Life Sciences Bisera Andrijašević authored the chapter on Serbia in the 2024 edition of Lexology Getting the Deal Through publication Pharma & Medical Device Regulation. The chapter provides a comprehensive overview of the legislative and regulatory landscape in Serbia, including insight into the regulatory framework related to obtaining and amending marketing […]

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The Government of Serbia repealed most of the recent restrictions on clinical trials in Serbia

As we 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 […]

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BDK Advokati advised shareholders of Amiga in the sale to Beam Global (NASDAQ: BEEM)

BDK Advokati advised shareholders of Amiga DOO, a regional leader in the production of poles for mobile networks, street lighting and innovative solar poles in the sale of 100% of shares to Beam Global (NASDAQ:BEEM). Beam Global is at the forefront of clean technology innovation, offering sustainable solutions for electric vehicle (EV) charging, energy storage, […]

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BDK Advokati advises Alcazar Energy on the acquisition of the windfarm project “Bijela” in Montenegro

BDK Advokati advised Alcazar Energy, a sustainable infrastructure fund, on the acquisition of the 118 MW wind farm project “Bijela” in Montenegro. BDK team was led by Senior Partner Luka Popović. Partner Milan Dakić provided construction-related advice. This is the first wind farm project for Alcazar Energy in the Western Balkans and we are happy […]

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“Tracking”, “monitoring”, and “profiling” in recent Clearview AI cases

In the past two years, most recently on May 10, 2023, when the Austrian Datenschutzbehörde issued its decision, supervisory authorities in several European countries declared the processing of personal data by the company Clearview AI to be contrary to the GDPR. To determine whether GDPR applied to the processing of personal data by the company […]

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BDK Advokati Tier 1 in IFLR1000 Financial and Corporate Law and Project Development 2023 rankings

We are pleased to announce that, according to the 2023 IFLR1000 rankings of law firms in Financial and Corporate Law and Project Development, BDK Advokati has maintained Tier 1 status in both Serbia and Montenegro. Our Project development practice in Bosnia & Herzegovina has also received significant recognition. IFLR1000 has ranked five of our partners […]

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New restrictions to clinical trials in Serbia

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 which negatively affect clinical trials in Serbia. The first amendment relates to the site of a clinical trial, […]

Bisera Andrijašević, Lexology GTDT – Pharma & Medical Device Regulation 2024 – Serbia

BDK Advokati’s Head of Life Sciences Bisera Andrijašević authored the chapter on Serbia in the 2024 edition of Lexology Getting the Deal Through publication Pharma & Medical Device Regulation. The chapter provides a comprehensive overview of the legislative and regulatory landscape in Serbia, including insight into the regulatory framework related to obtaining and amending marketing authorisations, clinical […]