Background
The ESMP enables marketing authorisation holders (MAHs) and national competent authorities (NCAs) to directly report information on the supply, demand, and availability of both nationally and centrally authorised medicines. These reports play a crucial role in crisis management and preparedness efforts led by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
The European Medicines Agency (EMA) has released several updates to the European Shortages Monitoring Platform (ESMP). The updated guidance supports regulators and pharmaceutical companies in reporting medicine shortages. The latest updates include the Implementation Guide, User Guide, Release Notes, and the Marketing Authorisation Holder template.
The new releases enhance monitoring and management of critical medicines during emergencies and preparedness efforts. It builds on the November 2024 launch of routine shortage reporting for centrally authorised medicines.
Starting February 2, 2025, ESMP use will be mandatory for MAHs and NCAs.
- European Shortages Monitoring Platform (ESMP) Implementation Guide for Marketing Authorisation Holders:
Date: 01/29/2025
Description: v1.2 Update of PMS ID fields:
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- Renamed PMS ID (Medicinal product) to PMS ID
- Renamed PMS ID (Packaged medicinal product) to Package PMS ID
- Highlight PMS guide link is only for reference and not mandatory to consult
- European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders
Version: V1.1
Date: 01/29/2025
Description: ESMP User guide for MAHs – second publication, integrating chapter 4 and 5 – respectively on Crisis submissions and Support
- European Shortages Monitoring Platform (ESMP) release notes
Version 2.0
This is the latest version of ESMP, a major release, with release date of January 29, 2025. Key functionality(ies): ESMP release 2.0 will introduce enhanced functionalities for both marketing authorisation holders (MAHs) and national competent authorities (NCAs), including: • Reporting of Availability information by MAH users in a crisis/MSSG-led preparedness phase, • Reporting of the Marketing status for NAPs by MAH users in a crisis/MSSG-led preparedness phase, • Reporting of Manufacturing information by MAH users in a crisis/MSSG-led preparedness phase, • Reporting of Alternative therapies by MAH users in a crisis/MSSG-led preparedness phase, • Reporting of Stock and supply by NCA users in a crisis phase, • Reporting of Patient estimation by NCA users in a crisis phase, • Reporting of Medicine usage by NCA users in a crisis phase, • Reporting of National demand by NCA users in a MSSG-led preparedness phase,
The ESMP’s Shortage monitoring and risk analysis tool (SMART), analyses the data on supply and demand submitted by MAH and NCA users during crisis events and the MSSG-led preparedness phase. The tool provides critical insights and functionalities, including: o Comprehensive overview for NCAs o Supply and demand matching indicators for NCAs o MSSG-led preparedness event-level insights for EMA
- MAH Template
Access Template via link: ESMP MAH Template
ESMP Guidances
european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf
european-shortages-monitoring-platform-esmp-release-notes_en.pdf