EU IDMP Implementation Guide

July 28, 2022

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

Highlights

  • 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: info@asphalion.com

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