Digital application dataset integration (DADI) Q&A webinar - variations form for human medicinal products

Table of contents

Date: 12/07/2022
Location: Online, 11:00 - 12:30 Amsterdam time (CEST)

Event summary

The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making the future form-filling and submission-handling process more efficient.

EMA launches the eAF variations web form in October 2022. This is a first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023.

The scope of the October release has been limited to Centrally Authorised Products (CAPs), due to complexity in synchronisation of the data between xEVMPD and PMS.

A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).

This event is a dedicated Q&A webinar for business and technical audiences from industry and national competent authorities to address questions about the revised scope of the DADI October Go-live.

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