ePI news

• 2024-05-31 [ePI] Sweden and the Netherlands complete their ePI pilots

• 2024-07-22 [ePI] FHIR Implementation Guide for ePI - Now live

• 2024-09-02 [ePI] Two new ePI NCA SMEs appointed

• 2024-09-05 [ePI] Pilot closes

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

• 2025-01-27 [ePI] Successful ePI pilot paves the way for ePI implementation: read the final report

  The ePI pilot report outlines essential development work and recommendations for implementing electronic Product Information in EU regulatory procedures

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

• [ePI] How to validate ePI against the EU ePI Common Standard

  Article describes how to validate FHIR files against the EU ePI Common Standard on a user's local machine

• 2025-04-01 [ePI] Open for consultation: reflection paper on accessing ePI from medicine package

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

• 2025-04-22 [ePI] Regulatory information - User testing of FHIR Import of electronic product information underway

• 2025-07-11 [ePI] User testing of FHIR Import of electronic product information completed

• 2025-09-22 [ePI] ePI Style guide available

• ePI QRD template lists

  Quality Review of Documents template lists provide identifiers, term names, term translations, hierarchy and attributes