14 Mar 2022

New proposal for a Polish act on clinical trials

Work is in progress on a proposal for an act on clinical trials of medicinal products for human use. The main purpose of the act is to transpose Regulation (EU) No. 536/2014 into Polish law and enforce it. The bill was first published for public consultation in April last year, and as of 17 January […]

19 Oct 2021

Significant changes to Polish reimbursement law are on the way

A proposal for an amendment to the Reimbursement Act was published on 30 June 2021. The bill is currently undergoing public consultations and will be submitted to the Sejm for debate next year. The main changes to reimbursement regulations would concern: inclusion of pharmaceutical companies in the payback mechanism at the point when the reimbursement […]

24 Dec 2021

Advertising of dietary supplements – trends in recent case-law in Poland

Administrative authorities and courts are clarifying the scope of health claims considered unacceptable. Health claims are claims that state, suggest or imply that a relationship exists between a food category, a food or one of its constituents, and health. They are used in the labelling, presentation and advertising of dietary supplements. Under EU law (Regulation […]

30 Jun 2021

Legal developments concerning medical devices

On 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices (MDR) came into force, and this means revolutionary changes in many areas of the medical devices industry. The regulation changes current regulations concerning clinical trials for the most technologically advanced products. It also […]