Purpose and Context
This is a dedicated page, serving as a comprehensive repository of essential links to Guidance Documents and Training Session on Product Management Service (PMS).
Explore these resources to gain valuable insights and practical knowledge, empowering your understanding of PMS.
1 - User Guides
- EU IDMP Implementation Guide (EU IG) for the submission of data on medicinal products defines the implementation requirements of the ISO IDMP standards for the EU. The EU IG is the basis for submitting and exchanging medicinal product data in the EU.
- Introduction chapter
- Chapter 1 - Registration requirements
- Chapter 2 - Data elements for the electronic submission of information on medicinal products for human use
- Chapter 3 - Process for the electronic submission of medicinal product information
- Chapter 5 - Data access/ export
- Chapter 6 - Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, calls, end-points
- Chapter 7 - Migration guide: migration rules between XEVMPD and PMS including backwards compatibility rules
- Chapter 8 - Practical examples
- Chapter 9 - Process for submitting existing data on medicinal products authorised for human use
- Product UI Guidance documents
- On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services: This document is intended to provide guidance and information for stakeholders supporting the implementation of the Substance, Product, Organisation and Referentials (SPOR) master data programme and for all stakeholders who are using the Substance Management Service (SMS), Product Management Service (PMS), Organisation Management Service (OMS) and Referentials Management Service (RMS).
2 - Q&A Documents
- Frequently Asked Document (FAQ) document for PMS (Updated - February 2025): This document contains a direct record of frequently asked questions (FAQs) through Slido.com during the Product Management Service (PMS) events over past months, complementing them. The FAQs are split per topic.
- Questions & Answers (Q&A) document for eAF & PMS (February 2024): This Question and Answer (Q&A) document is for information only and is based on
insights available at the time of its release. The aim is to regularly update and re-release this document.
3 - Training Sessions
- Public webinar on pack size submissions: from XEVMPD to PMS (11 July 2024) explaining how pack sizes should be submitted to XEVMPD to support the European Shortages Monitoring Platform (ESMP) and how they will be incorporated into Product Management Service (PMS), providing an overview of the entire process.
- PMS API Training session (8 July 2024) providing a thorough explanation on access and data read for the PMS API, including a comprehensive demo.
- Q&A Clinics on PMS PUI:
- PMS Product UI Training session (3 June 2024) providing a comprehensive overview of PMS Product UI, including a demo showcasing how to use the system.
- PMS Deep-dive webinar (22 February 2024): providing a comprehensive overview of PMS implementation and its implications on other EMA digital services.
4 - Union list of critical medicines
Union List of Critical Medicines: The EU (Union) list of critical medicines enables EMA, the European Commission and the Heads of Medicines Agencies (EMA) to work together to ensure they can take proactive measures to avoid medicine shortages. It contains human medicines whose continued supply is considered a priority in the EU, to avoid serious harm to patients and help healthcare systems function. Medicines on this list will be prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions.
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 submission in XEVMPD of packages undertaken by MAHs until 31 May 2025.