The European Medicines Agency (EMA) published version 1.5 of the European Shortages Monitoring Platform (ESMP) Implementation Guide for Marketing Authorisation Holders (MAHs) on 28 April 2026, providing updated technical specifications for electronic submission of shortage and supply data. The guide, which applies under Regulation (EU) 2022/123, impacts MAHs, national competent authorities, and EMA by mandating structured data submissions for both routine shortages and crisis preparedness.
Document scope and key updates
The implementation guide covers routine shortage submissions for centrally authorised products (CAPs) and crisis/MSSG-led preparedness submissions for both CAPs and nationally authorised products (NAPs). Version 1.5 introduces several updates: addition of readable RMS IDs for data elements, extension of shortage start dates to from 1 January 2019, and clarification that CAP marketing status in IRIS affects only the Availability information template. The guide also mandates accurate product master data in PMS, including structured package and manufacturing site information.
Policy orientations and trade-offs
The ESMP aims to enhance EU-wide monitoring of medicine shortages, balancing public health protection against administrative burden on MAHs. The extension of shortage start dates to 2019 increases data completeness but may require MAHs to retrieve older records. The requirement for structured package and manufacturing site data improves traceability but imposes additional compliance costs on companies.
Impact on stakeholders
- MAHs: Must update internal systems to comply with new data fields and extended historical reporting, increasing operational costs. However, standardised submissions may reduce long-term regulatory friction.
- National competent authorities: Gain access to more comprehensive and consistent shortage data, improving their ability to coordinate responses.
- EMA: Receives higher-quality data for the ESMP, supporting better crisis management and supply continuity.
- Patients: Indirectly benefit from improved shortage monitoring, potentially reducing medicine stock-outs.
Expected institutional follow-up
The guide is effective immediately. MAHs should align their submission processes with v1.5 to avoid compliance issues. EMA may issue further updates as the platform evolves.