eAF news

• 2024-05-15 [eAF] New look for the PLM Portal Home Page

• 2024-11-28 [eAF] Updated PLM Portal eAF Release notes now available (28-11-2023)

• 2024-11-14 [eAF] Updated PLM Portal eAF FHIR XML Release notes now available (14-11-2023)

• 2024-07-12 [eAF] Recommended use of web-based human variations eAF for all CAP variations

• 2024-10-14 [eAF] Non-CAPs data available in web-based eAF

• 2024-12-13 [eAF] Update on the start of strongly recommended use of web-based eAF for NCA submissions

• [eAF/PMS/ePI] Email authentication to EMA systems - Timeline to convert your user

• 2025-02-27 [eAF] Updates and training sessions in Quarter 1 2025

• 2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems

• 2025-02-13 [eAF] Production go-live for submissions of human variations web-based eAFs for non-CAPs

• 2025-03-05 [eAF] PLM Portal eAF – Integrity stamp go-live on 6 March

• 2025-04-04 [eAF] Update on web-based Human variation electronic Application Forms (eAFs) timeline

• 2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025

• 2025-05-21 [eAF] Recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs

• 2025-06-27 [eAF] Training session on Human variations web-based eAF for non-CAPs - 1 Jul 2025

• 2025-07-02 [eAF] Q&A Clinic on web-based application form functionalities for CAPs and non-CAPs - 8 July 2025 10:00 - 11:00 (CEST)

• 2025-07-15 [eAF] Progressing towards the PLM portal web-based eAF

• 2025-07-31 [eAF] PLM Portal eAF Q&A Document

• 2025-08-29 [eAF] Announcement of trainings and Q&A sessions on web-based Human variations eAFs for CAPs and non-CAPs

• 2025-09-23 [eAF] Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs

• 2026-01-19 [eAF] New variation classification in eAF