Life Sciences

The Upcoming Amendment to the Act on Pharmaceuticals: Will it Mark the end of Drug Shortages?

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.

Draft Regulation of the Polish Ministry of Health On Medical Device Advertising

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 Advises Dr Irena Eris Group on Acquisition of Sulfur Zdroj Exim

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

Forms of Promotional Activities Covered by the Polish Medical Device Act

The Polish Medical Devices Act of 7 April 2022 (the MDA) does not provide a definition of medical device advertising or criteria that could allow a clear assessment of whether an activity is advertising and what requirements it should meet.

Closing: Sale of Health Labs Care to Medvic Now Closed

On January 9, 2023, WKB announced that the sale of Health Labs Care to Medvic (reported by CEE Legal Matters on September 28, 2022) had closed following regulatory approval.

Advertising Medical Devices to the Public in Poland

The Polish Medical Devices Act of 7 April 2022 (the MDA) imposes certain restrictions on the medical device advertising that is addressed to the general public. Such advertising activities must not be misleading (Article 7 of the MDR or the IVDR, and Article 55(3) of the MDA), but also must not:

Specialists, Team, and Work Ethic: Octavian Popescu on Celebrating Four Years of Popescu & Asociatii

It’s been four years since we sat down with Octavian Popescu, Managing Partner at Popescu & Asociatii, and discussed what was at that time the new firm’s perspective and its future plans. We reached out again, on the firm’s Fourth Anniversary, to see how those plans have been progressing and chart the firm’s development.