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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
2026-04-17 [PMS] The new mandate for PMS Subject Matter Experts (SMEs)
2026-04-17 [PMS] PMS public API pilot release: powering EU health data exchange
2026-04-10 [eAF] Upcoming mandatory use of PLM web-based eAF for CAPs
2026-04-10 [ePI] Updated ePI FAQ document available
2026-04-10 [ePI] Draft ePI roadmap published
[ePI] How to validate ePI against the EU ePI Common Standard
2025-01-27 [ePI] Successful ePI pilot paves the way for ePI implementation: read the final report
2026-01-19 [PMS] Save the date: PMS Info-Day is coming up on 9 June 2026!
2025-01-10 [PMS] SPOR & XEVMPD Status update webinar
2026-01-19 [PMS] Q&A clinics on PMS Product User Interface (PUI) and Application Programming Interface (API) - from Jan to May 2026
2026-04-10 [eAF] Upcoming mandatory use of PLM web-based eAF for CAPs
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
2025-04-04 [eAF] Update on web-based Human variation electronic Application Forms (eAFs) timeline
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
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
2026-04-17 [PMS] The new mandate for PMS Subject Matter Experts (SMEs)
2026-04-17 [PMS] PMS public API pilot release: powering EU health data exchange
2026-01-19 [PMS] Save the date: PMS Info-Day is coming up on 9 June 2026!
2025-01-10 [PMS] SPOR & XEVMPD Status update webinar
2026-01-19 [PMS] Q&A clinics on PMS Product User Interface (PUI) and Application Programming Interface (API) - from Jan to May 2026
2026-01-19 [PMS] Registration open for SPOR, XEVMPD and PMS webinar series in 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
2026-04-10 [ePI] Updated ePI FAQ document available
2026-04-10 [ePI] Draft ePI roadmap published
[ePI] How to validate ePI against the EU ePI Common Standard
2025-01-27 [ePI] Successful ePI pilot paves the way for ePI implementation: read the final report
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
2025-09-22 [ePI] ePI Style guide available
2025-07-11 [ePI] User testing of FHIR Import of electronic product information completed
2025-04-22 [ePI] Regulatory information - User testing of FHIR Import of electronic product information underway
2025-04-01 [ePI] Open for consultation: reflection paper on accessing ePI from medicine package
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