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Update on web-based Human variation electronic Application Forms (eAFs) timeline

Following the human variation web-based eAF announcement of first use for non-CAPs in the Product Lifecycle Management (PLM) Portal, EMA has updated the eAF roadmap.
 
date: [04/04/2025]
In Q1 2025, the human variation web-based eAF was opened to use for non-Centrally Authorised Products (non-CAPs) through the PLM Portal, allowing Marketing Authorisation Holders to use the web-based application form for all EU human variation procedures, including for submissions to the NCAs.
Key points of the updated timeline:
Q2 2025:
  • Expected announcement of Recommended use of Human variation eAF for non-CAPs. Please watch this page for further updates.
  • Continue the incremental release of the new user experience improvement e.g., scope selection, procedural information,
  • The incremental release of new features, including maintenance and optimisation updates as well as performance improvements.
Q3 & Q4 2025:
  • Expected announcement of Strongly Recommended use of Human variation eAF for non-CAPs.
  • Exploration of structured changes in eAF.

Please report any production issues through the ServiceDesk. Any change request or other generic questions please direct them to PLM.ValueStream@ema.europa.eu
 

Recommended and strongly recommended use refer to the levels of the iterative, phased approach EMA applies to the introduction of web-based eAFs.
These are the levels:
Optional Use: Both the interactive PDF and the web-based eAF are available. Applicants may choose either format, and no preference is expressed.
Recommended Use: The use of the web-based eAF is encouraged. However, applicants may continue to use the interactive PDF if they are not yet ready to adapt their internal processes.
Strongly Recommended Use: The web-based eAF should be used in most cases. The interactive PDF should only be used if specific constraints prevent the use of the web-based eAF (e.g., technical issues or missing features).
Mandatory Use: The use of the web-based eAF is required. Submissions using the interactive PDF will not be accepted. Mandatory use will only be introduced after a formally announced transition period.