SSK&W has advised VC fund Medi Ventures on its investment in clinical trial platform Virtual Monitor.
B2RLaw and DZP Advise on Vinci HiTech Fund Investment into Oasis Diagnostics
B2RLaw has advised the Vinci HiTech ASI fund on its nearly PLN 14 million investment into Polish medical technology start-up Oasis Diagnostics. Domanski Zakrzewski Palinka advised Oasis Diagnostics.
Weinhold Legal Advises Eureking on Acquisition of SCT Cell Manufacturing from PPF Group
Weinhold Legal has advised Eureking on the acquisition of SCT Cell Manufacturing from PPF Biotech.
Major Legislative Changes in Hungary's Pharma and Food Industry
Significant legal changes occurred in the Hungarian pharmaceutical and food industry in the summer of 2023. According to Government Decree No. 333/2023. (VII. 20.), as of 1 August 2023, the National Public Health Centre (NNK) and the National Institute of Pharmacy and Nutrition (OGYÉI) merged, establishing a new authority, the National Centre for Public Health and Pharmacy (Nemzeti Nepegeszsegugyi es Gyogyszereszeti Kozpont, NNGYK).
Reform of the Pharmaceutical Sector Taking Shape in Kosovo: A New Law on the Pricing of Medicinal Products Approved
Kosovo has recently adopted a new law to regulate the pricing of medicinal products (Law on Pricing of Medicinal Products). This marks the first time that Kosovo has taken steps to regulate the pricing of medicinal products, and it is a significant milestone in an upcoming major reform within the healthcare and pharmaceutical sector. The reform also includes new laws on medicinal products and medical devices, health insurance, and related areas.
Protection of Personal Data in Clinical Trials
May 2023 marks five years since the application of the General Data Protection Regulation, better known as "GDPR", and its requirements still pose a number of challenges for organizations. On one hand, this is because ensuring compliance with GDPR is not a "one-time exercise" but a continuous process "from within", requiring synchronization with all other activities in the organization. On the other hand, companies must also take into consideration innovations "from the outside", including new regulations and technologies, by promptly addressing data protection risks.
Albania – Legalization of Cannabis for Medical and Industrial Purposes
On Friday 21 July 2023, the Albanian Parliament adopted a law which legalizes medical cannabis and industrial hemp (“Cannabis Law”). The Cannabis Law allows licensed companies to cultivate and process cannabis and determines the criteria which must be met to obtain such a permit, but also regulates the cultivation process of the plant and the production of its by-products for medical and industrial purposes.