27 Jul 2022

Advertising of dietary supplements: the more charges, the harsher the penalty?

At the end of April, the President of UOKiK announced initiation of proceedings for practices infringing the collective consumer interest against a trader dealing in dietary supplements. The list of allegations is considerable. And for each of these — under a new debatable fining method — the authority can impose a separate severe financial penalty. […]

02 Jun 2022

New rules on advertising medical devices

There has been a major change to laws regarding advertising of medical devices[1] in Poland due to another Act on Medical Devices being passed, of 7 April 2022.[2] The current rules at EU level have changed in accordance with the adopted premise that more extensive and uniform protection is needed, at least to a minimum […]

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 […]

05 Jun 2022

Cannabis in Poland – significant changes in legislation, jurisprudence and on the market

The cannabis plant contains many different cannabinoids. The most popular one is THC, (Tetrahydrocannabinol), a substance triggering a narcotic effect. CBD (Cannabidiol) is the second most known cannabinoid  identified in cannabis. It is believed not to have negative psychoactive effects and indicates calming effects. As of 2019, clinical research on CBD included studies related among other things […]

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 […]