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Life Science

Changes in food labelling

A ruling of the Supreme Administrative Court confirmed that the use of peel-off labels is, in principle, allowed and that there is no obligation to include all mandatory information on one top layer of the label. The use of several label layers will not lead to hiding mandatory information if the top label indicates where the remaining information can be found. Earlier, domestic interpretations ruled out such a possibility.

Life Science

The EMA has released official guidance on the protection of personal data and commercially confidential information in the Clinical Trials Information System (CTIS)

It is compulsory to use the Clinical Trials Information System (CTIS) when filing any new applications for clinical trials from 31 January 2023. The CTIS is a website designed for the implementation of Regulation 536/2014 on clinical trials. Although the regulation was adopted almost ten years ago, there is still uncertainty surrounding the implementation of the regulation’s requirements concerning greater transparency of clinical trials and, in particular, the scope of information to be published in the CTIS.

Life Science

Profound changes to the regulatory data protection rules are expected any day now

As a part of the Pharmaceutical Strategy for Europe, the European Commission (EC) announced that it would launch a package revising the general pharmaceutical legislation, as well as the regulations on orphan medicinal products and paediatric medicines.

Life Science

Market exclusivity and its increasing relevance for the pharmaceutical industry

According to the last IQVIA survey, Protection Expiry and Journey into the Market. Pharmaceutical products in Europe, regulatory exclusivities and rewards provided the longest-lasting form of protection for 57% of the drugs studied. For 31% of innovative medicines, market exclusivity is the last form of protection to expire.

Life Science

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

Life Science

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

Life Science

New rules on advertising medical devices

There has been a major change to laws regarding advertising of medical devices in Poland due to another Act on Medical Devices being passed, of 7 April 2022.

Life Science

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 2022, following the publication of statements submitted during the consultation process, has been forwarded to the European Union Affairs Committee.

Life Science

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

Life Science

Significant changes to Polish reimbursement law are on the way

Life Science

Legal developments concerning medical devices