Recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible.
date: [21/05/2025]
This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now recommended for use for all procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf forms. Consult the guidance and the release notes.
Please report any production issues through the EMA ServiceDesk - Incident. Any change request or other generic questions, recommendations, improvement suggestions please raise them through EMA ServiceDesk - Request
PLM Portal web-based eAF use 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.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)