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: [email protected]
