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News

Previous DADI news can be found here

24-05-2022

DADI Project Human variations forms updated timeline & revised go-live scope

DADI Human Variations Form Timeline (May 2022)

Following the publication of the DADI timeline in February 2022 please find an updated timeline for the release of web-based variations form for Human medicinal products, including key milestones.
  • Currently, the variations form for Human medicinal products is undergoing closed User Acceptance Testing (UAT) with members of the DADI Subject Matter Expert Group, which is expected to conclude in August 2022.
  • Subsequently, there will be external User Acceptance Testing with a larger, but still limited, group of testers representing various stakeholders. The product team have rescheduled the external UAT from Q2 2022 to September 2022. More information around the UAT organisation will be communicated in June. The UAT will serve to test the system's functions. It will not be set up to facilitate early access to the web user interface for a large group of users.
  • The target go-live date for the release of the form remains unchanged (October 2022).
Scope of Initial release of Human Variations eAF web form

At initial release of the Human variations form in October 2022, the scope will primarily cover a conversion of the current interactive PDF format eAF form to the new web-based format where the main change is to select the product/presentation impacted by the variation from PMS. Future releases will progressively replace more free text data fields with structured data fields. Additionally, the web forms will introduce mandatory use of OMS for all procedure types which is new for non-Centralised procedures.

DADI documentation:

DADI webinars:

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

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