EMA’s third DADI (Digital Application Dataset Integration) webinar was organised on 16 May 2022. The recording and the presentations from the event will be published on EMA’s eSubmission website.
The first web-based form to be released in the DADI project is a variations form for human medicinal products, and it is still expected to go live in October 2022. According to the current plan, there will be a 6-month transition period, which means that using the first web-based form will be mandatory from April 2023. For an ongoing variation application process, there is normally no need to switch to a web-based form. However, if completing a national process takes several years, it may be necessary to replace the original form with a web-based form in case EMA no longer supports the current version. For now, it is not known for how long the current version of the form will be supported.
DADI uses PMS (Product Management Services) data from the xEVMPD database. Therefore, any potential gaps in the database will be reflected in the PMS data too.
The marketing authorisation holder (MAH) needs to grant permissions in the system to all the persons authorised to submit marketing authorisation applications for the MAH’s pharmaceutical products. This applies to both the MAH’s own employees and the consultants. EMA promised to provide more information about this in their next webinar.
A more comprehensive user experience (UX) testing is planned, but it has been postponed to September. EMA will give further details about this soon. If you are interested in the UX testing, we will be happy to give it a try with you. Please get in touch with your contact person at DRA to discuss this further.