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ePI news

Announcements, including go-lives, upcoming changes, and other important updates

  • 2026-09-25 [ePI] ePI Training for Applicants now available in the PLM portal
  • 2026-09-08 [ePI] Guide on submitting ePI in centralised procedures published
  • 2026-09-04 [ePI] ePI Guide for Translators available
  • 2026-08-28 [ePI] Call for testers: User testing of electronic product information underway
  • 2026-07-20 [ePI] NCA ePI Open Day supports readiness for implementation across the EU regulatory network
  • 2026-05-27 [ePI] Newly appointed ePI NCA SMEs
  • 2026-04-10 [ePI] Updated ePI FAQ document available
  • 2026-04-10 [ePI] Draft ePI roadmap published
  • 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
  • [eAF/PMS/ePI] Email authentication to EMA systems - Timeline to convert your user
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