PMS guidance documents

1.1 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 5 - Data access/ export
    • Annex A
  • 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
    • Annex
  • 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).

1.2 Q&A Documents

• Frequently Asked Document (FAQ) document for PMS (August 2024): 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.

• 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:
  • Q&A Clinic 1 (6 June 2024)
  • Q&A Clinic 2 (13 June 2024)
  • Q&A Clinic 3 (20 June 2024)
  • Q&A Clinic 4 (27 June 2024)
• 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. 

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.

Union list of critical medicines: XEVMPD/ PMS entries: A list of products and pack sizes to assist MAHs and NCAs in mapping their products in EMA's PMS. This list is based on the first version of the Union list of critical medicines.