On 31 January 2022, the “new” Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC (the “Regulation“) will enter into force. After several delays (the launch was originally planned for 2015), the European Medicines Agency (the “EMA”) has confirmed to the Commission that the EU portal and the EU database, which were a prerequisite for the launch, are now fully functioning. At the same time, the EMA confirmed that the EU portal and database will be put into operation on 31 January 2022. As of this date, the Regulation will become fully applicable in all EU Member States.
The Czech Republic’s Office for the Protection of Competition Will Intensify Its Focus on the Pharmaceutical Sector
According to its recently published annual report, the Office for the Protection of Competition of the Czech Republic (the "Office") plans a thorough investigation of the pharmaceutical sector, in terms of compliance with both competition and public procurement rules.
Deal 5: Practica Capital Co-Founding Partner Donatas Keras on Investment in Biomatter Designs
On January 18, 2021, CEE Legal Matters reported that Cobalt had advised Practica Capital on its investment in Lithuanian start-up Biomatter Designs – part of the latter's EUR 500,000 investment round. CEEIHM spoke with Donatas Keras, Co-Founding Partner at Practica Capital to learn more about the matter.
Telemedicine in Romania – a Myth that Will Become Reality
Access, equity, quality, and cost-effectiveness are key issues facing healthcare in both developed and less developed countries. Modern information and communication technologies (ICTs), such as computers, the Internet, and cell phones, are revolutionizing how individuals communicate with each other, seek, and exchange information, and enrich their lives. These technologies have great potential to help address contemporary global health problems.
Opportunities in the Life Science Sector
According to the Life Science Report Austria, Austrian biotech companies recorded a turnover of USD 379.3 million in 2017, with USD 206.3 million – or 54.6% – flowing into research and development.
New Case Law Sheds Light on Requirements Regarding Promotional Activities of Pharmaceutical Companies in Hungary
Recently published case law from Hungary’s National Institute of Pharmacy and Nutrition – the Hungarian acronym is OGYEI – deals with various aspects of pharmaceutical promotional activities and interactions with health care providers. The OGYEI investigated the commercial practices of Aramis Pharma Kft., Lilly Hungaria Kft., and Sager Pharma Kft., and imposed fines following the discovery of infringements.
Is the Market for Medical Devices in Slovenia and Within the EU Becoming More Significant?
The significance of medical devices is most certainly on the rise, considering not only its importance to patients, for whom medical devices represent life enhancing products, but also developments in innovation, economics, and in the regulatory and legal sphere. Issues such as data privacy in the field of medical devices were not noticeable until connectivity became a trend in medical devices and the GDPR was adopted. Similarly, the possibility of a cyber-attack on a medical device connected to the Internet became a possibility. Even though the question of product liability has always been present, recent decisions by the European Court of Justice provided new interpretations of existing legal terms and, importantly, introduced product batch liability.