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MAHs to prepare for PMS edit function in support of shortage monitoring

From Q1 2025, EMA will launch write access for Marketing Authorisation Holders (MAHs) through the Product Management Service (PMS) Product User Interface (PUI) first and Application Programming Interface (API) later. This functionality will be crucial for shortages monitoring via the European Shortages Monitoring Platform (ESMP). MAHs should start preparing.
 
date: [16/10/2024]
 
Write access will enable the enrichment of data concerning structured pack size, data carrier identifier(s) and manufacturer in PMS, information required by ESMP. Standardised product information availability in PMS will simplify reporting requirements for both MAHs and National Competent Authorities (NCAs) to the ESMP.
 

What should MAHs do now to prepare?

1) Submit pack sizes in XEVMPD following Chapter 3.II instructions.

2) Verify that data submitted to XEVMPD is correctly displayed in PMS – for both Centrally Authorised Products and non-Centrally Authorised Products (either through the PUI or the PMS API).
What should you do in case of any discrepancies or doubts about the data displayed? please check Chapter 7 and Chapter 9 of the EU IDMP Implementation Guide (IG), while in case of additional questions MAHs should open a EMA Service Desk Ticket by following the instructions in the “Support” section of the PUI navigation guide.

3) Start gathering information on structured data for pack sizes, data carrier identifier(s) and manufacturers to be ready for its submissions through PMS. Please note:

  • The edit capability will be available for PMS PUI:
     
    • For non-CAPs by last week of January 2025 – edit in API later in Q1 2025.
    • For CAPs, MAHs will be able to provide data carrier IDs through Service Desk at a later stage (between end of Q1 and Q2 2025).
  • From 3 February 2025, MAHs should submit this data in PMS for all their non-CAPs, using the EMA 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). Final deadline: December 2025.
Upcoming informative webinars:
  • EMA is organising a public webinar on 29 October 2024 (10:00 – 12:00 (CET)) to showcase the PMS PUI, recap current & future key actions for Marketing Authorisation Holders and answer users’ questions. Register here
  • EMA is organising a public webinar on 25 November 2024 (10:00 – 11:30 (CET)) to explain how manufacturers and manufacturing business operations should be submitted to PMS to support the European Shortages Monitoring Platform (ESMP), providing an overview of the entire process. Register here
Upcoming Q&A Clinics on PUI and API:
 
 
Keywords: PMS, MAHs, ESMP