Union list of critical medicines
The Union list of critical medicines helps prevent issues with the supply and availability of medicines at European Union (EU) level.
HumanMedicine shortages
Updated on 19 January 2026:
- Published editorial update to the Union list of critical medicines
- Added Annual review methodology document
The Union list of critical medicines enables the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) to work together to ensure they can take proactive measures together to avoid medicine shortages.
This list contains human medicines whose continued supply is considered a priority in the EU.
It helps healthcare systems function and avoid serious harm to patients.
For more information on availability of medicines, see:
Union list of critical medicines
Review history
EMA, HMA and the European Commission drafted the list in phases. The list now undergoes an annual review to ensure that all medicines included continue to meet the criteria for being considered critical.
Further details on the medicines included in each version are available below.
- 2026
Editorial update to second version of the list
Terminology used to describe the route of administration was updated throughout to ensure interoperability with other systems using standardised product information. No changes were made to the medicines included in the list.
- 2025
Annual update to second version of the list
The network assessed 61 active substance groups and combinations and added 9 of these to the list.
- 2024
Second version of the list
The second version builds on the first version and accounts for approximately 75% of all authorised medicinal products in the EU.
It was based on additional existing resources including the EMA list of main therapeutic groups.
- 2023
Questions and answers
A questions and answers document on the Union list is also available below:
How the network uses the list
Medicines on the Union list are prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions.
EMA also uses this list in the establishment of a product management database supporting the standardisation of product information in the EU and European Economic Area (EEA).
The list includes innovative medicines and generic medicines for human use.
These medicines cover a wide range of therapeutic areas - such as vaccines and medicines for rare diseases.
How the network identifies critical medicines
EU Member States assign critical medicine status based on a methodology developed with input from key stakeholder groups. This includes patient and healthcare professionals organisations, and pharmaceutical industry associations.
A critical medicine is identified by combining two criteria:
- Seriousness of the disease
- Availability of alternative medicines
A medicine also has to meet additional criteria to be included in the list, such a defined number of Member States that consider the medicine to be critical or the marketing status of the medicine.
Annual updates ensure that the network can add or remove medicines as needed based on changes to their criticality.
EMA invites Member States and stakeholders to suggest medicines for addition or removal each year, using the established annual review methodology below.
Preventing medicine shortages
The European medicines regulatory network will closely monitor the medicines on the Union list and implements measures to minimise the risk of supply disruptions.
It will do so via existing processes and structures, as defined in the mandate of EMA’s Medicines Shortages Single Point of Contact (SPOC) Working Party and its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
Additional obligations for marketing authorisation holders and national competent authorities are further defined in the upcoming proposed EU pharmaceutical legislation.
The European Commission has analysed the vulnerabilities in the supply chain of selected critical medicines in the Union list. In July 2024, the Commission published the main findings for the first tranche of 11 critical medicines in a technical report.
In October 2023, the Commission published a communication on addressing critical shortages of medicines. This document lays out the plans for regulatory and industrial policy measures to address supply chain vulnerabilities.
The Commission may propose measures to address vulnerabilities and strengthen security of supply for critical medicines, including:
- recommendations for companies to diversify suppliers or increase production within the EU;
- incentives for investment;
- additional regulatory obligations for companies;
- procurement with strong contractual obligations for delivery.
These measures will support the prevention and mitigation of shortages, and ensure appropriate and continued supply of critical medicines for patients and healthcare systems across the EU.
For more information, see:
Support implementation of standardised product information
Information helping marketing authorisation holders and national competent authorities to map their products in EMA's product management service (PMS) is available to registered users with full access to the Product Lifecycle Management portal (PLM):
This helps them report data on the supply and demand of medicines to the European Shortages Monitoring Platform. It is part of their mandatory reporting requirements and is meant to help prevent, detect and manage human medicine shortages.
Guidance on how to access the dynamic product reports that contain this information is also available on the PLM portal.
In February 2025, these reports replaced the list of products and pack sizes that EMA previously made available. This document was based on the first version of the Union list of critical medicines. The document is outdated but remains available below for information.
Mapping products in the PMS supports the implementation of standardised product information across the EU and EEA.