European Shortages Monitoring Platform (ESMP) goes live

The European Medicines Agency EMA announced that the European Shortages Monitoring Platform (ESMP) started with the full scope of functionalities on 29 January 2025 (which is ahead of the pre-defined deadline on the 2nd of February). All Marketing Authorisation Holders MAHs are obliged now to only use the platform to report data on medicine shortages and availability issues.

In addition to the routine shortage reporting by MAHs of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is now available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). MAHs and NCAs will be able to use these functionalities in the event of a public health emergency, major event, or MSSG-led preparedness activity.

ESMP change adoption survey on transition period for routine shortage reporting

Approaching the end of the transition period for routine shortage reporting by CAP MAHs on 2 February 2025, EMA kindly seeks feedback on the experience made so far. Kindly note that after the end of the transition period all CAP shortages are required to be reported through the ESMP. This can be done by this short survey by 7 February 2025.

If you want to learn more about the ESMP, please refer to the Guidance and training materials section on the ESMP webpage.

EMA also reminds stakeholders of the requirement to register an industry single point of contact (i-SPOC) for supply and availability, which is mandatory for all marketing authorisation holders the EU/EEA, in line with Regulation (EU) 2022/123. Stakeholders should make sure that they have registered an i-SPOC through EMA's IRIS platform and ensure that it is kept up to date.