The European Medicines Agency (EMA) published version 1.3 of the European Shortages Monitoring Platform (ESMP) User Guide for National Competent Authorities (NCAs) on 28 April 2026, providing updated instructions for reporting medicine supply and demand data under Regulation (EU) 2022/123. The guide is intended for NCAs in EU/EEA Member States, who are responsible for accurate data submission to help prevent and manage medicine shortages.
The user guide, issued by EMA's internal unit responsible for the ESMP, is a technical manual rather than a binding legal instrument. It outlines procedures for NCAs to report data during public health emergencies or major events (crisis submissions covering stock/supply, patient estimation, and medicine usage) and for MSSG-led preparedness actions (national demand). Version 1.3 introduces new chapters on critical shortages and the Voluntary Solidarity Mechanism (VSM), as well as the CAP shortages in EU/EEA tool. The guide covers account creation, access roles (ESMP NCA Admin and User), login procedures with multi-factor authentication, and step-by-step processes for downloading templates, completing data fields, and uploading files.
The updated guide aims to improve the timeliness and accuracy of shortage data, which can help NCAs and the EMA respond faster to supply disruptions. However, the detailed reporting requirements may increase administrative burden for NCAs, particularly those with limited resources. The new VSM chapter could facilitate voluntary redistribution of medicines among Member States, potentially reducing shortages but requiring coordination and trust. The guide does not impose new legal obligations but clarifies existing ones under Regulation (EU) 2022/123.
NCAs are expected to implement the updated procedures in their daily operations. The EMA may issue further updates as the platform evolves or in response to feedback from users. No immediate legislative or regulatory action is anticipated.
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