ePI - Regulatory information - User testing of FHIR Import of electronic product information underway
EMA has opened a call for testers to participate in a UAT for FHIR import of ePI. Applications can be submitted via a sign-up survey until 19 May.
date: [22/04/2025]
EMA has opened a call for testers to participate in a UAT of FHIR import of ePI.
FHIR import functionality enables users to import ePI in FHIR XML format directly into the product lifecycle management (PLM) portal.
EMA is looking for interested companies that have experience in working with FHIR XML, that can create FHIR files by following the Implementation Guide provided and that can bring their own test files to user testing. EMA will not provide test files for this round of testing.
For further details and to express interest in taking part, companies should use the sign-up survey.
Further information on the EU ePI Common Standard for ePI can be found in the ePI Implementation Guide, the User Guide for Applicants and in the Guide on validating ePI locally.