Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.

Fresenius Medical Care has appointed Belgrade-based Mirko Lalatovic to the role of Head of Compliance, Central & South East Europe, EMEA.

Former Telekom Romania Data Protection Officer George Manea has joined KPMG Legal Toncescu si Asociatii as a Senior Managing Associate and Head of the firm’s Life Sciences, Technology & Compliance practice.

For the last couple of months, we have all experienced a shortage of certain pharmaceuticals on the market, especially antibiotics or pharmaceuticals for fever reduction for children. Given that this situation reoccurs almost every flu season, the Ministry of Health of the Czech Republic has newly established a formal working group monitoring the availability of pharmaceuticals on the market. The Ministry of Health is also preparing the amendment to the Act on Pharmaceuticals so that it can, on its own or in cooperation with the State Institute for Drug Control („SUKL“), better respond to urgent drug shortages in case of crisis situations.

The draft regulation of the Minister of Health on medical device advertising (the Draft) provides for further restrictions and requirements on advertising to the public. The Draft is intended to be a clarification of the technical requirements for advertising medical devices that have been introduced at the statutory level in the Polish Medical Devices Act of 7 April 2022 (the MDA).

Crido Legal has advised the Dr Irena Eris Group on its acquisition of pharmaceutical company Sulfur Zdroj Exim.