From 3 February 2025, registered MAHs and NCAs users can use the EMA Product Management Service (PMS) dynamic product reports available to registered users in the PLM portal (user guidance to access dynamic product reports is available here) to identify the list of products and pack sizes products corresponding to the latest version of the Union list of critical medicines (i.e. version 2, released in December 2024).    

This helps Marketing Authorization Holders (MAH) and National Competent Authorities (NCAs) meet the reporting requirements for the mandatory submission to the European Shortages Monitoring Platform of data on the supply and demand of medicines during crises and preparedness actions. 

MAHs and NCAs can access relevant products by selecting multiple ATC codes via the dynamic product reports dashboard and/or exporting reports from the PMS dynamic product reports dashboard by applying additional filters, such as routes of administration in accordance with version 2 of the Union list of critical medicines. 

As communicated in August 2024, MAHs can prioritise medicines on the Union list of critical medicines to submit specific product information on pack sizes and manufacturing information. In contrast, NCAs can use this list to prioritise product mapping in their national systems. 

The release of version 2 of the Union list of critical medicines has prompted the EMA to extend the data enrichment task for pack sizes undertaken by MAHs until 31 May 2025.