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Completion of non-CAPs data load on PMS Product UI

The data load of non-Centrally Authorised Product* (non-CAP) information on the PMS Product User Interface (PUI) has been successfully completed. As of now, all human non-CAP and CAP data is available in read-only mode via the PUI on the Product Lifecycle Management (PLM) Portal.
 

date: 18/09/2024

 
Key actions for National Competent Authorities (NCAs) & Marketing Authorisation Holders (MAHs):
  • NCAs & MAHs to request the new PMS roles needed for accessing the PMS PUI through the EMA Account Management portal.
  • MAHs to review the non-CAP data in the PUI, ensuring consistency with the information in XEVMPD. If any discrepancies are found or there are any doubts about the data displayed, please check Chapter 7 and Chapter 9 of the EU IDM 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.
  • NCAs & MAHs to join the training session on 16 October 2024 (10:00 – 11:00, CEST). Register here. During the session, the PMS team will provide an overview of the PUI, showcase the access and navigation and answer your questions. Meanwhile, you can consult the presentation & recording of the previous training session on PUI, held on 3 June 2024.
  • Attend Q&A Clinics (if needed): In October 2024, the PMS team will host 30-minute Q&A sessions focused on API & Product User Interface (PUI) usage:
  • NCAs & MAHs to consult PMS PUI guidance documents to support their work on the PLM Portal:

Please be reminded that this data load will not yet trigger the availability of non-CAPs data in the web-based eAF. Once performance improvements are completed, non-CAPs data will become available in the eAF.
Read access to both CAPs and non-CAPs through the PMS PUI is a key step toward the data-centric target operating model. This milestone builds on the go-live of the PMS Application Programming Interface (API) for CAPs and non-CAPs in read-only mode for MAHs on 3 July 2024 and the launch of the PMS PUI in read-only mode for CAPs on 31 May 2024.

Next steps

  • In Q1 2025, the EMA plans to introduce write access for MAHs through both the PUI and API. This functionality will be crucial for shortages monitoring via the European Shortages Monitoring Platform (ESMP) in 2025, as it will enable the enrichment of structured package size, data carrier identifier(s)   and manufacturer data in PMS.
  • To prepare for this, Marketing Authorisation Holders (MAHs) must first submit package size data in XEVMPD (presentation & recording of dedicated July 2024 training session). Standardised product information will simplify reporting requirements for both MAHs and National Competent Authorities (NCAs) to the ESMP.
  • Following this MAHs will need to submit into XEVMPD & PMS the mentioned product information by 2 February 2025 for all products in their portfolio listed in the “Union list of critical medicines: XEVMPD/PMS entries”.

If you have any question, please consult the PMS Frequently Asked Questions (FAQ) document. If your question is not answered there, please contact plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.


* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)