European Commission (EC) publishes list of critical medicines Read More

The European Commission has published the first Union list of critical medicines, together with the European Medicines Agency (EMA) and the Member States’ Heads of Medicines Agencies (HMA). This first Union critical medicines list contains more than 200 active substances used in human medicines. While inclusion of an active substance is not an indication of likely shortage, it still signifies critical importance. EC will take all necessary steps and work with relevant stake holders to prevent shortages and ensure uninterrupted supply of these critical medicines. The European medicines regulatory network will closely monitor the medicines on the Union list and implement measures to minimise the risk of supply disruptions. EC will analyse supply chain vulnerabilities; may propose measures to address vulnerabilities and strengthen security of supply:

• 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.

The Union list of critical medicines will be reviewed annually. The review will continue in 2024 and cover authorised medicines not included in the first review.

Union list of critical medicines

EMA Document