European Shortages Monitoring Platform operational

The European Shortages Monitoring Platform (ESMP) went live this week. The platform enables marketing authorisation holders and national competent authorities to directly report information on supply, demand and availability of medicines. This concerns medicinal products authorised at both the national and the European level. 

Marketing authorisation holders are obligated to use the platform to report supply interruptions of centrally authorised medicines to the European Medicines Agency (EMA). Please note that all obligations at the national level will remain in effect; supply interruptions in the Netherlands must therefore also be reported to the Medicine shortages and defects notification centre.

The ESMP is a deliverable of EMA’s extended mandate under Regulation (EU) 2022/123 for the monitoring and mitigation of shortages of critical medicinal products. The platform allows reporting during both crises and preparedness actions led by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). 

In crisis situations, the ESMP will help manage acute shortages by enabling quick reporting and coordination. The MSSG will use the platform during preparedness actions: to identify shortage risks at an early stage and take preventive measures, in order to prevent crises and limit their impact. 
 

Marketing authorisation holder obligations

From 2 February 2025, marketing authorisation holders and national competent authorities will be obligated to use the ESMP. The reporting obligations for marketing authorisation holders are set out in the ESMP Implementation Guide for Marketing Authorisation Holders.

To use the ESMP, marketing authorisation holders must register their Industry Single Point of Contact (i-SPOC). A number of marketing authorisation holders still need to complete the obligatory i-SPOC registration. Now that the ESMP is live, it is even more important that companies register their i-SPOCs as soon as possible. For more information on the ESMP, please visit the EMA website.  
 

The ESMP and the Medicine shortages and defects notification centre

In addition to the obligation to report through the ESMP, national obligations will also remain in effect. In the Netherlands, marketing authorisation holders must report supply interruptions of centrally authorised medicines both to the EMA and to the Medicine shortages and defects notification centre.