Human Variations Electronic Application Forms (eAF) (DADI) Go-live Q&A Session

6 December 2022 – the EMA published the Q&A guidance on human variations eAF go-live Q&A session held on 27 October 2022 and 8 November 2022.

The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new dedicated PLM portal. These Q&A sessions attempted to address questions from industry and national competent authorities’ stakeholders concerning the release of the web-based variations eAF for Human CAPs.

Human Variations eAF go-live Q&A session (27 October 2022) Human Variations eAF go-live Q&A session (8 November 2022)