European Shortages Monitoring Platform (ESMP) User Guide for MAHs

The European Shortages Monitoring Platform (ESMP) User Guide helps Marketing Authorisation Holders (MAHs) report and manage shortages of Centrally Authorised Products (CAPs).

The latest update introduces:

• A new sign-in process with email authentication
• Updated screenshots for easier navigation
• Instructions on downloading and completing the ESMP reporting template
• Steps for uploading data, reporting, and updating shortages
• Pre-filled fields, validation rules, and Excel formatting guidance
• Submitting shortage prevention and mitigation plans
• Accessing submission history and validation results
• Resolving reported shortages

The guide has been updated multiple times since March 2025, with the most recent revision on January 29, 2025.

Source: https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf

Region: European Union