As of today, 31 May 2024, the Product Management Service (PMS) Product User Interface (PUI) has gone live in read-only mode for registered users via the Product Lifecycle Management (PLM) Portal.

Registered users (Marketing Authorisation Holders and National Competent Authorities) can now view Centrally Authorised Product (CAP) data. Nationally Authorised Product (NAP)   data will be available on the PUI in read-only mode by the beginning of Q3 2024.

This milestone is part of the roadmap toward a data-centric target operating model. Write access for PMS, planned for Q4 2024, will be crucial for enhancing package size and manufacturer data for 2025 shortages monitoring. MAHs must first submit package size data in XEVMPD.

Due to quality concerns in the read functionality of the PMS Application Programming Interface (API), the latter will be released at the beginning of July 2024, instead of today. The API will also go live in read-only mode for both CAPs and NAPs data.

Using the PUI

• The new PMS roles required for accessing the PMS PUI can now be requested in the EMA Account Management portal.
• Data Review: MAHs must check that their product information in PMS PUI is consistent with XEVMPD. Discrepancies or doubts should be reported via an EMA Service Desk Ticket following the “Support” section of the PUI navigation guide.
• Training Session: A public webinar on 3 June 2024 (10:00 – 11:30 CEST) will provide an overview of the PUI and API, with specific training on PUI. Register here, and consult the event web page for further information.
• Q&A Clinics: Weekly 30-minute sessions every Thursday in June (15:00 – 15:30 CEST) to answer PUI-related questions:
  • 6 June 2024: register here
  • 13 June 2024: register here
  • 20 June 2024: register here
  • 27 June 2024: register here

Guidance Documents:

• PMS Product UI registration guide
• PMS Product UI navigation guide
• PMS Product UI known issues document

Additional Guidance:

• On-boarding of users to Substance, Product, Organisation, and Referentials (SPOR) data services: Updated to include an explanation of PMS PUI & API roles and role differences from Referentials Management System (RMS) and Organisation Management System (OMS).
• EU IDMP Implementation Guide (IG) Chapter 1: Updated registration requirements reflecting changes in the PMS registration process.

A public product report named “Human Medicinal Product Overview report” with limited CAP data is also available on the PLM Portal without registration, following the principles stated in EU IG Chapter 5 (PMS data access level 1).