Poland

Guidance on qualification and classification of safety wristbands used in telecare services and recognition as medical devices

Guidance on how to qualify and classify safety wristbands used in telecare services as medical devices and their regulatory classification.

Information from the President of URPL on the CMDh Coordination Group meeting of 21-22 July 2026

CMDh coordination group concluded benefit-risk ratio of valproate-containing medicinal products remains unchanged; marketing authorisation holders requested to submit Type II C.9.c variation within 6 months.

Notice: Polish Office of Medicinal Products, Medical Devices and Biocidal Products closure on 14 August 2026

W związku z postanowieniami Zarządzenia nr 2 Prezesa Rady Ministrów z dnia 5 stycznia 2026 r. w sprawie wyznaczenia dla członków korpusu służby cywilnej dni wolnych od pracy, informujemy, że w dniu 14 sierpnia 2026 r....

Notice on additions to the EDQM Standard Terms database

Polish translations of new standard terms for routes of administration and organ preservation have been added to the EDQM Standard Terms electronic database.

Information from the President of URPL on the CMDh Coordination Group meeting of 23–25 June 2026

CMDh coordination group abolished the requirement to attach cover letters to Type IA variation applications, effective 1 July 2026.

Notice of the President of URPL of 22 June 2026 on new and amended chapters and monographs in the European Pharmacopoeia 12.3

URPL President's Information on the Annual Report of the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products for 2025

Information on the distribution of the Polish Pharmacopoeia, 12th edition

The Polish medicines regulator announces reduced prices for the 12th edition of the Polish Pharmacopoeia and confirms current distribution arrangements.

Availability of Supplement 2025 to the Polish Pharmacopoeia, 13th Edition

Electronic version of Polish Pharmacopoeia XIII with Supplement 2025 is out of stock; printed version available from Cogno Medical.

Polish Pharmacopoeia XIII: Supplement 2025 – electronic version availability notice

Electronic version of Polish Pharmacopoeia XIII cumulative edition with 2024 and 2025 supplements now available for purchase; print edition exhausted.

URPL President participates in 100th anniversary celebration of the Faculty of Pharmacy at the Medical University of Warsaw

Office experts educate children on safe medicine use

Polish medicines authority runs educational programme in primary schools to build health awareness and safe medicine practices among children.

132nd meeting of the Management Board of the European Medicines Agency

Information from the President of URPL on the translation of recommendations from the European Commission Expert Group on Veterinary Medicinal Products concerning the use of veterinary medicinal products in accordance with Articles 112-114 of Regulation (EU) 2019/6