EU IDMP Implementation Guide

July 28, 2022

Version 2.1.1 of the EU IDMP Implementation Guide has been published! Check it out here.


  • Up-to-date alignment of the Product Management Service (PMS) data model with the web-based application forms by the Digital Application Dataset Integration (DADI) Network project
  • Support the go-live of the web-based Human variations form for Human medicinal products in October 2022.

What has changed?

  • Further details on the data elements introduced to support the new web-based forms
  • Updated business rules and FHIR paths for these data elements
  • Updated details on the applicable RMS lists
  • Further examples and clarifications

Guideline updates

  • Chapter 2: Data elements for the electronic submission of information on medicinal products for human use.
  • Annex I to Chapter 7: Migration rules between EMA’s internal database, SIAMED and PMS for centrally authorised products
  • Chapter 8 – Practical examples

Annex to EU IG Chapter 8 – Practical examples

All other chapters of the EU IG v2 remain valid and applicable.

More releases of further updates are expected during 2022 and 2023. These further updates would include:

  • Process clarifications for the centralised procedure;
  • Replacing the Article 57 submissions with the FHIR data exchange standard in chapter 3. This is expected at a later stage.


In case you need further information you can contact us at:

Search News & Events

  • Filter by category


Related news and events

2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) – often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

Cena Navidad AEFI 2022 ASPHALION

AEFI ‘Xmas dinner

Una representación de expertos de Asphalion acudió anoche a la tradicional cena de Navidad de la Sección Catalana de AEFI en Barcelona. En Asphalion somos

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting