The EU (Union) list of critical medicines enables EMA, the European Commission and the Heads of Medicines Agencies (EMA) to work together to ensure they can take proactive measures to avoid medicine shortages.

It contains human medicines whose continued supply is considered a priority in the EU, to avoid serious harm to patients and help healthcare systems function.

Medicines on this list will be prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions.

The European medicines regulatory network published the first version of the list in December 2023.

It includes both innovative medicines and generic medicines for human use covering a wide range of therapeutic areas - such as vaccines and medicines for rare diseases.

It contains over 200 active substances selected after EU Member States reviewed 600 active substances from existing national lists of critical medicines. The review will continue in 2024 and cover authorised medicines not included in the first review.

A questions and answers document on the Union list is also available. 

Methodology

EU Member States assign critical medicine status based on a methodology developed with input from key stakeholder groups, with patient and healthcare professionals organisations, and pharmaceutical industry associations among them. 

A critical medicine is identified by combining two criteria, the seriousness of the disease and the availability of alternative medicines. A medicine also has to meet additional criteria to be included in the list, such as being critical in at least one-third of EU / European Economic Area countries.

Measures to prevent medicine shortages

The European medicines regulatory network will closely monitor the medicines on the Union list and implement 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.

Additional obligations for marketing authorisation holders and national competent authorities are further defined in the upcoming proposed EU pharmaceutical legislation.

As proposed in its October 2023 communication on addressing critical shortages of medicines, the European Commission will also analyse the supply chain of critical medicines to determine potential vulnerabilities.

In such cases, the Commission and EMA's Executive Steering Group on Shortages and Safety of Medicinal Products may propose measures to address vulnerabilities and strengthen security of supply for these 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.