EU IDMP Implementation Guide (EU IG)

Last updated: 13 January 2026

To view updates, click on the ‘+’ sign below.

DateUpdate(s)
13 Jan 2026Entire table updated with latest links.
18 Oct 2025In the table, the last updated dates for Chapter 1 Registration requirements was updated to 15 October 2025
2 October 2025In the table, the last updated date for Chapter 1 Registration requirements was updated to 30 September 2025
23 Aug 2025In the table, the last updated dates for Chapters 1, 2, 3 and 9 have been updated.
7 May 2025In the section Chapters of EU IDMP Implementation Guide, the last updated date and links were updated for the following:
Chapter 2 – 5 May 2025
Chapter 3 – 18 Feb 2025
Chapter 9 – FAQs 13 Feb 2025
18 Dec 2024The Table in the section Chapters of EU IDMP Implementation Guide was updated.
– Specifically, some links and Last updated date were updated.
– A new document Product Management Service (PMS) – Frequently Asked Questions (FAQs) was also added.

For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post.

The 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. 

Its purpose is to enable stakeholders to prepare for the implementation of ISO IDMP standards in the EU.

It provides information on the following: 

  • Timelines
  • Requirements
  • Process
  • Technical specification
  • Data elements
  • Associated business rules
Chapters of EU IDMP Implementation Guide

The EU Implementation guide is composed of the chapters below. 

ChapterChapter NameLast updated date
IntroductionEU Implementation Guide14 May 2024
Chapter 1Registration requirements15 October 2025
Chapter 2Data elements for the electronic submission of information on medicinal products for human use8 Aug 2025
Chapter 3Process for the electronic submission of medicinal product information15 Oct 2025
Chapter 4Data quality assurance – This chapter is scheduled for inclusion in subsequent releases of the EU IG.Not yet available
Chapter 5Data access/export
Data access to medicinal products for human use 14 May 2024
Data access to medicinal products for human use – Annex A: Product data elements accessible by stakeholder group19 June 2025
European Medicines Agency’s data protection notice for Product Management System (PMS) activities2 May 2025
Chapter 6Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, call, end-points
Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe 11 Feb 2020
Substances, Products, Organisations, Referentials (SPOR): SPOR API v2 Specification11 Feb 2020
European Medicines Agency Write PMS API implementation Guide5 Nov 2025
Chapter 7Migration guide: Migration rules between xEVMPD and PMS including backwards compatibility rules
Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 71 July 2024
Chapter 8Practical Examples
Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 8

Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – track changes

Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Annex I: Complete representation
27/07/2022
Chapter 9Process for submitting existing data on medicinal products authorised for use
Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas – Chapter 930 June 2025

Applicants can start applying the rules in the latest update to structure their product data. This enables them to complete and correct any product data as necessary before the use of the electronic application forms becomes mandatory at the end of a transition period.

Source: European Medicines Agency