Life Sciences News in Poland – January 2026

January regulatory guidance highlights how thin the line between compliance and real enforcement risk has become in the Life Sciences sector.

In recent weeks, regulators have focused on clarifying obligations imposed on businesses, in particular in the areas of medicinal products, healthcare and cosmetic products. These developments have a direct impact on compliance processes, reporting obligations and the regulatory exposure of market participants.

In the January regulatory newsletter, we discuss, among other topics:

• Medicinal products: new positions of the Polish Office for Registration of Medicinal Products (URPL) on the rules for agreeing and disseminating DHPC communications, as well as a reminder of obligations related to the systematic assessment of nitrosamine contamination risks, including the need to conduct confirmatory testing
• Healthcare and pharmaceutical distribution: changes to delivery plan reporting in the ZSMOPL system and new rules for notifying transport means to the Chief Pharmaceutical Inspectorate (GIF), non-compliance with which may result in administrative sanctions
• Cosmetic products: new restrictions on the use of selected substances classified as CMR, with a clearly defined deadline for bringing products placed on the market into compliance

We also highlight further enforcement actions taken by the Patient Ombudsman against so-called “e-prescription platforms”, as well as the good practice principles published by the EMA regarding the use of AI throughout the lifecycle of medicinal products.

We encourage you to read Life Sciences – January 2026 Regulatory Update, prepared by the DLA Piper Poland team: Dr Andrzej Balicki, Jolanta Dąbrowicz and Urszula Grębowska.