Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs
As of 29 September 2025 EMA has started strongly recommending the use of the PLM Portal web-based eAF for all non-CAPs human variations. This step is aligned with the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
date: [23/09/2025]
Following the steps towards optional use of the web-based eAF for non-CAPs in February 2025 and the start of the recommended use in May 2025, EMA now strongly recommends the use of the PLM Portal web-based eAF for all non-CAPs* human variations, where possible. This step follows the timeline and the roadmap towards eventual 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. While the PLM Portal eAF is now strongly recommended for use for all human variations procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf form. Consult the guidance and the release notes.
Please report any issues with using the web-based eAF to the EMA ServiceDesk - Incident. Any change request or other generic questions, recommendations, improvement suggestions can be raised 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)
Please note that the interactive PDF eAF remains available for use for all variation procedures. While the PLM Portal eAF is now strongly recommended for use for all human variations procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf form. Consult the guidance and the release notes.
Please report any issues with using the web-based eAF to the EMA ServiceDesk - Incident. Any change request or other generic questions, recommendations, improvement suggestions can be raised 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)
| Overview of the adoption process of the web-based eAF for all human variations | ||
| CAPs | Non-CAPs | |
| Optional use | Nov ‘22 | Feb ‘25 |
| Recommended use | May ‘24 | May ‘25 |
| Strongly recommended use | July ‘24 | Sep ‘25 |
| Mandatory use (following formal transition) | TBD | TBD |