Progressing Towards the PLM Portal Web-Based eAF
In a progression towards eventual transition, from late Q3 2025, EMA will strongly recommend use of the web-base eAF for non-CAPs applications, with the PDF version to be used only in exceptional cases. EMA currently already recommends using the PLM Portal web-based eAF for all non-CAPs human variation applications and already strongly recommends it for all CAPs human variations.
date: [15/07/2025]
Following the start of optional use for all non-Centrally Authorised Products (non-CAPs)human variations in February 2025, from May 2025 the European Medicines Agency (EMA) May 2025 recommends the use of the PLM Portal web-based electronic Application Form (eAF) for non-CAPS, EMA strongly recommends it for all CAPs human variations.
These progressive phases of recommendation are fully aligned with the overall roadmap towards mandatory use of the web-based eAF for all human variation procedures, which relies on a gradual adoption process comprehensive of four steps: Optional, Recommended, Strongly Recommended and Mandatory use. A formal transition period will be triggered before mandatory use.
With recommended use, EMA encourages applicants to employ the web-based eAF where possible and to report through proper channels any issue or blocker encountered during its use. If applicants are not able to use the web-based eAF, the interactive PDF eAF remains available. For further details, please consult the guidance and the release notes.
If no major blockers or constraints are raised and identified during the recommended use phase, EMA foresees to launch the strongly recommended use for non-CAPs human variations by the end of Q3 2025. From that point onward, the web-based eAF should be used in most cases. The interactive PDF eAF should only be used where specific constraints prevent use of the web-based solution, such as unresolved technical issues or missing functionality.
To support continued improvement, please report any production issues via the EMA ServiceDesk - Incident. For change requests, general questions, suggestions, or recommendations for improvement, use EMA ServiceDesk - Request. Additional feedback – including positive feedback – is also welcome and strongly encouraged, as it helps us enhance the system and move in the right direction.