The European Medicines Agency has launched the European Shortages Monitoring Platform. For reporting at European level, marketing authorisation holders can now report shortages for centrally authorised medicines to the European Medicines Agency through this platform. For reporting at national level, PharmaStatus remains the reference in Belgium for reporting medicine shortages.
Marketing authorisation holders are required to report shortages for centrally authorised medicines to the European Medicines Agency (EMA). During the transition period, which started on November 28, 2024, marketing authorisation holders can continue to report these shortages through the regular procedure (via email). The transition period will end on February 2, 2025, when the use of the European Shortages Monitoring Platform (ESMP) becomes mandatory. Marketing authorisation holders are encouraged to use the new ESMP as much as possible to become familiar with it. This requires registration of an i-SPOC person through this procedure.
The release of the ESMP is a major milestone in the effort to tackle medicine shortages. The platform centralises and automates data collection, allowing regulatory authorities in the European Union (EU) and European Economic Area (EEA) to better understand medicine shortages. This also helps to prevent shortages and resolve them more quickly so that patients maintain access to the medicines they need.
In February 2025, the functionalities of the ESMP platform will be extended for marketing authorisation holders and national competent authorities. Data will then also be collected on the demand, supply and availability of centrally and nationally authorised medicines during a crisis or situations that could potentially lead to a crisis, led by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). In addition to the manual uploading of data, work continues on the interoperability between the various systems that should enable the transmission of data via machine-to-machine. Moreover, the ESMP will also ensure that information on unavailable medicines becomes publicly available.
PharmaStatus
The launch of the ESMP does not change current obligations to report medicine shortages. Pharmaceutical firms in Belgium are required to submit notifications for nationally and centrally authorised medicines through PharmaStatus. This platform facilitates the notifications that must legally be made by firms (start or stop of marketing and unavailability). The FAMHP follows up all reports and is therefore better informed of the situation in the field.
More information
European Shortages Monitoring Platform
Availability of medicines