Life Sciences News in Poland – March 2026

The regulatory environment in the areas of pharmaceutical law, medical devices, and food remains highly dynamic – successive amendments and draft legislative acts significantly affect the activities of entities across the entire supply chain of the life sciences sector.

In the latest newsletter from DLA Piper Poland, the team of Andrzej Balicki, Ph.D., Jolanta Dąbrowicz and Urszula Grębowska discusses, among others:

• changes in Good Distribution Practice, including obligations concerning the replacement of the Responsible Person and reporting to the Main Pharmaceutical Inspectorate (GIF),
• new rules for confirming the qualifications of the Qualified Person and Competent Person,
• a new application form for a permit to operate a pharmaceutical wholesale establishment,
• implementation of version 1.43 of the ZSMOPL system (changes in validation and reporting),
• a communication from the Office for Registration of Medicinal Products (URPL) regarding obligations related to EUDAMED,
• draft regulations concerning pesticide residues in food,
• changes regarding enriching substances added to food (including new prohibitions).

We invite you to read further.

If you have any questions regarding the impact of new regulations on your organization, we encourage you to contact us.