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Guidance and training materials are available to support users in getting access to and navigating the PLM portal – eAF
Guidance and training materials are available to support users in getting access to and navigating the PLM portal – ePI
Guidance and training materials are available to support users in getting access to and navigating the PLM portal – PMS
2026-01-19 [PMS] Save the date: PMS Info-Day is coming up on 9 June 2026!
2026-01-19 [PMS] Q&A clinics on PMS Product User Interface (PUI) and Application Programming Interface (API) - from Jan to May 2026
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2025-04-24 [PMS] Explore the updates to the Substance and Product Management Service webpage
2025-02-20 [PMS] MAHs and NCAs users can now use PMS dynamic product reports to identify Union list of critical medicines (ULCM) products
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2025-06-27 [eAF] Training session on Human variations web-based eAF for non-CAPs - 1 Jul 2025
2025-02-27 [eAF] Updates and training sessions in Quarter 1 2025
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)
2025-04-04 [eAF] Update on web-based Human variation electronic Application Forms (eAFs) timeline
2024-12-13 [eAF] Update on the start of strongly recommended use of web-based eAF for NCA submissions
2025-09-23 [eAF] Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs
2025-05-21 [eAF] Recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs
2026-01-19 [PMS] Save the date: PMS Info-Day is coming up on 9 June 2026!
2026-01-19 [PMS] Q&A clinics on PMS Product User Interface (PUI) and Application Programming Interface (API) - from Jan to May 2026
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2025-04-24 [PMS] Explore the updates to the Substance and Product Management Service webpage
2025-02-20 [PMS] MAHs and NCAs users can now use PMS dynamic product reports to identify Union list of critical medicines (ULCM) products
2025-07-11 [PMS] PMS EU IG updates and upcoming events in Q3 and Q4 2025
2025-06-26 [PMS] PMS Info Day 2025: Strengthening Product Data Integration and Readiness
2025-08-08 [PMS] Release of updated PMS EU IG chapter 2 and PMS API Write IG
2025-06-30 [PMS] SOR & XEVMPD monthly Q&A clinics planned in 2025 (& extended PMS Q&A Clinics)
2025-04-14 [eAF/PMS/ePI] Email authentication for EMA applications – Complete your account conversion by 8 May 2025
2025-01-30 [eAF/PMS/ePI] Reminder of email authentication to EMA systems
2024-07-22 [ePI] FHIR Implementation Guide for ePI - Now live
2024-09-05 [ePI] Pilot closes
2025-09-22 [ePI] ePI Style guide available
2025-07-11 [ePI] User testing of FHIR Import of electronic product information completed
2024-09-02 [ePI] Two new ePI NCA SMEs appointed
2024-05-31 [ePI] Sweden and the Netherlands complete their ePI pilots
2025-01-27 [ePI] Successful ePI pilot paves the way for ePI implementation: read the final report
2025-04-22 [ePI] Regulatory information - User testing of FHIR Import of electronic product information underway
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EMA Account Management portal | How to create a new EMA account