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Update Digital Application Dataset Integration (DADI) – Revised Go-Live Scope

Update Digital Application Dataset Integration (DADI) – Revised Go-Live Scope

As mentioned in one of our posts published in June this year, the Digital Application Dataset Integration (DADI) will be introduced in the regulatory landscape from October 2022. DADI is a Network Project using new web-based applications forms in a dedicated portal which will be replacing the current electronic application forms as we know it nowadays. 

Initially, EMA intended to start this project with the variation forms for human medicinal products, authorised via the Centralised Procedure or nationally (via DCP/MRP/NP). However, this has been changed and at the go-live at the end of October only products registered via CP will be part of the scope. Later, in March 2023, the use of DADI will be extended to the nationally authorised products (DCP/MPR/NP) and will then also include mixed CAP/NAP Worksharing. From March 2023 a transition period will start, until September 2023 where both DADI and e-AF can be used in parallel. From September 2023 onwards, the use of DADI for variation applications will become mandatory for all CAPs and NAPs.

As a future user of DADI, make sure to have at least an active EMA account. There are different user roles within the system, with different rights, which can be assigned to your EMA account. 

Lastly, also be reminded that the organisation on whose behalf you will be acting, must be listed in EMA’s Organisation Management System (OMS).

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Update Digital Application Dataset Integration (DADI) – Revised Go-Live Scope