Information on the ESMP for Marketing Authorisation Holders New
To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.
The ESMP aims to provide a framework for the monitoring and management of medicinal shortages during public health emergencies and major events. As part of this framework, pharmaceutical industry and Member States will be required to provide information on both the medicinal product, as well as the supply and demand level.
Attached below, marketing authorisation holders will find information on routine reporting of shortages of centrally authorised medicinal products, as well as guidance on reporting obligations during crisis or a preparedness action. Further information can be found in the FAQs.
To address any remaining questions regarding the ESMP and the reporting obligations of marketing authorisation holders, the EMA is hosting a Q&A-session for marketing authorisation holders on 24 June 2025 from 10:30 to 12:00 CEST.
