2nd Version of the Union list of Critical Medicines published

On 16 December 2024, the European Commission, together with the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), issued an updated version of the Union list of critical medicines and the updated version of the corresponding Q&A document. This publication follows the first publication of the list on 12 December 2023. More information regarding the initial publication, can be found in our news article on the first publication of the Union list of critical medicines.

The Union list of critical medicines is an important tool to address potential shortages of essential medicines and to ensure their availability. It includes medicines for human use that are considered essential for the effective functioning of the health systems in the EU. Medicines are classified as critical on the basis of two main factors: the severity of the condition they treat and the lack of viable alternative therapies.

It is important to note that inclusion in the list does not imply that these medicines are at risk of shortage. Rather, it indicates the need for preventive measures to secure their supply and prevent disruptions that could affect patient care.

The Union list includes innovative and generic medicines, including those used to treat rare diseases. It is based on an analysis of around 2,200 active substance groups and combinations, equivalent to 75% of authorised medicines in the EU. The updated version of the Union list expands on the first by reviewing additional medicines from existing crisis preparedness lists and active substance groups identified by EMA stakeholder groups.

To safeguard the supply of these critical medicines, the EMA and the European medicines regulatory network will actively monitor their availability and implement measures to minimize supply chain vulnerabilities. The European Commission has already carried out a review of supply chain vulnerabilities for 11 medicines on the list. The results were published on 10 July 2024. The report is available here.

The Union list complements national lists of critical medicines, but is not a replacement for them. For Member States without a national list, the Union list can provide a basis for developing one.

Medicines on the WHO list of essential medicines are not automatically included in the Union list of critical medicines.
Medicines will be included in the Union list on the basis of criteria specifically relevant to the EU health system and priorities.

The list will be periodically reviewed and updated to add new critical medicines or remove those that no longer meet the criteria. While the current list covers a review of 75 % of the authorised medicines for human use, efforts are being made to review the remaining 25%.