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.
- 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 for production environment
- 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
- European Medicines Agency's data protection notice for Product Management Service (PMS) activities
- 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).
Upcoming monthly Q&A Clinics: Monthly Q&A sessions to answer your questions regarding the Product Management Service (PMS) User Interface (PUI) and the Application Programming Interface (API).
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.