EU IDMP Implementation Guide (EU IG)

Last updated: 16 May 2024

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
IDMP Guidance update history
DateUpdate
Jul 2022Further details on the data elements introduced to support the new web-based forms introduced by the DADI project
Updated business rules and FHIR paths for these data elements
Updated details on the applicable RMS lists
Further examples and clarifications
Details on migration rules applied between EMA’s internal database, SIAMED and PMS for centrally authorised products 
Jun 2021Enhanced data-related aspects, including aligning the PMS data model with the web-based application forms created by the DADI project
Feb 2020Guidance first published
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 Requirements 14 May 2024
Chapter 2Data elements for the electronic submission of information on medicinal products for human use27 July 2022
Chapter 3Process for the electronic submission of medicinal product information – EMA will update Chapter 3 in due course to capture the impact of the new web-based forms in the data submission process.
Chapter 4Data quality assurance – This chapter is scheduled for inclusion in subsequent releases of the EU IG.
Chapter 5Data access/export
Data access to medicinal products for human use
Data access to medicinal products for human use – Annex A: Product data elements accessible by stakeholder group
14 May 2024
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

Substances, Products, Organisations, Referentials (SPOR): SPOR API v2 Specification
11 Feb 2020
Chapter 7Migration guide: Migration rules between xEVMPD and PMS including backwards compatibility rules 30 Jan 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 –

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 July 2022
Chapter 9Practical examples for submitting existing data on medicinal products authorised for human use 30 Jan 2024

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

Update(s)
DateUpdate
16 May 2024Overall update to the post based on information on the EMA website.