New National List of Critical Medicines.

On 14 July 2025, the Minister of Health presented an updated National List of Critical Medicines, covering 401 active substances. During the preparation of the update, the active substances included in the second edition of the European Critical Medicines List published on 16 December 2024, which were not included in the first National List of Critical Medicines, were analysed, as were proposals for active substances submitted during consultations by National Consultants in Health Care, the GIF, the President of the URPL, ministries and other bodies/institutions (including the Ministry of National Defence, the Ministry of the Interior and Administration, the NFZ, the National Medicines Institute, the NIA, the NIL, the Government Agency for Strategic Reserves), responsible entities and the public.

The methodology of the update was based on assigning each of the reported active substances an ATC class and assessing the following criteria: the presence of a given active substance on the European List of Critical Medicines; clinical criticality - based on the opinion of National Consultants; criticality in terms of manufacturing sites, equivalents and availability – based on the opinion of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Chief Pharmaceutical Inspector; average monthly sales volume; category of availability of medicinal products with a given active substance.

In addition, the Ministry of Health pointed out that, in accordance with the adopted assumptions, for kr

In addition, the Ministry of Health pointed out that, in accordance with the adopted assumptions, combination medicines containing at least one of the active substances included in the List are also considered critical.

Link: https://www.gov.pl/web/zdrowie/krajowa-lista-lekow-krytycznych---aktualizacja