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

Date	Update
Jul 2022	Further 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 2021	Enhanced data-related aspects, including aligning the PMS data model with the web-based application forms created by the DADI project
Feb 2020	Guidance first published

Chapters of EU IDMP Implementation Guide

The EU Implementation guide is composed of the chapters below. 

Chapter	Chapter Name	Last updated date
Introduction	EU Implementation Guide	14 May 2024
Chapter 1	Registration Requirements	14 May 2024
Chapter 2	Data elements for the electronic submission of information on medicinal products for human use	27 July 2022
Chapter 3	Process 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 4	Data quality assurance – This chapter is scheduled for inclusion in subsequent releases of the EU IG.	–
Chapter 5	Data 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 6	Technical 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 7	Migration guide: Migration rules between xEVMPD and PMS including backwards compatibility rules	30 Jan 2024
Chapter 8	Practical 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 9	Practical 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)

Date	Update
16 May 2024	Overall update to the post based on information on the EMA website.