Human Variations eAF (DADI) go-live Q&A session

• Date:
  Thursday, 27 October 2022, 14:00 (CEST) - 15:00 (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new dedicated PLM portal. This is a first step towards making the form-filling and submission-handling process more efficient.

The web-based variations form for human medicinal centrally authorised products (CAPs) will be released on 4 November 2022.

This event is a Q&A webinar aiming at addressing questions from industry and national competent authorities’ stakeholders concerning the release of the web-based variations eAF for Human CAPs.

Video recording

Documents

Questions and answers - Human Variations eAF go-live Q&A session (27 October 2022)