NEWS | ESMP Essentials and Industry Reporting Requirements

July 1, 2024

The European Medicines Agency (EMA) has outlined the European Shortages Monitoring Platform (ESMP) and detailed the necessary actions for Marketing Authorization Holders (MAHs) to complete by February 2025.

This platform aims to prevent and manage shortages by collecting supply and demand data from National Competent Authorities (NCAs) and MAHs, particularly during crises and emergencies.

Actions Required by MAHs:

  • Check that all Products included in the Union List of Critical Medicines are submitted to the xEVMPD prior to the ESMP go live in February 2025.
  • Examine data for Centrally Authorized Products (CAPs) and Nationally Authorized Products (NAPs) using the PMS API and the Product User Interface.
  • From Q1 2025, start with the enrichment of non-CAPs by adding information about Manufacturers and structured data regarding pack sizes.

 

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