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PMS data submission deadlines extended

Extension of PMS submission deadlines for the enrichment for non-Centrally Authorised Products (part of ULCM) to June 2026 and all other non-Centrally Authorised Products to June 2027. The December 2026 deadline for structured Manufacturer's data remains unchanged.
 

date: 10/09/2025

 
The European Medicines Agency (EMA) is extending the following PMS data submission deadlines:
  • Enrichment of structured Manufacturer's data and pack size for non-CAPs (part of Union list of critical medicines (ULCM)) using Product UI and API: deadline extended to June 2026 (previously December 2025)
  • Enrichment of pack sizes for all other non-CAPs using XEVMPD and structured pack sizes using PMS PUI and API on the company's portfolio: deadline extended to June 2027 (previously December 2026)

Note: the deadline of December 2026 to submit structured Manufacturer's data for all other non-CAPs on the company's portfolio using PMS PUI and API remains unchanged.

The extension follows deliberations on Industry feedback regarding the deadlines and an assessment of possible impacts on the PMS delivery roadmap.