Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs
24 September 2025 EMA launched the human variations web-based electronic Application Form (eAF) for optional use for non-CAPs* in February, and recommended use in May. From 29 September 2025, the use of web-based eAF is strongly recommended for all non-CAPs* human variations on the PLM portal, where possible. 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 strongly recommended for...
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