DADI web-based variations forms timeline update

February 4, 2022

EMA has informed of an update to the timeline for the release of DADI web-based variations forms for Human medicinal products.

The changes are the following:

  • The target go-live date of April 2022 has been revised to October 2022
  • The go-live will be followed by a 6-month transition period (previously 12-month minimum) during which both the PDF eAF and the web-based form can be used in parallel.
  • The variations form for human medicinal products is undergoing closed UAT with members of the DADI SME Group which will be followed by testing of the PMS data that the forms will use. More information will be shared during Q1 2022.
  • There will be an integrated UAT in Q2 2022 with a group of testers representing various stakeholders (including Industry).

The new timeline can be found here: Introducing DADI – The Digital Application Dataset Integration Network Project to replace electronic application forms (europa.eu)

 

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