User testing of FHIR UAT Import of electronic Product Information completed
20 organisations successfully completed the FHIR Import UAT for electronic Product Information. The analysis of the feedback clears the way for the further development of this important ePI feature
date: 11/07/2025
The European Medicines Agency (EMA) has successfully completed the User Acceptance Testing (UAT) for the Fast Healthcare Interoperability Resources (FHIR) import functionality of electronic Product Information (ePI).
This functionality enables users to import ePI in FHIR XML format directly into the Product Lifecycle Management (PLM) portal.
This User Acceptance Testing was designed to simulate the import process of a FHIR file from the perspective of a pharmaceutical company or a service provider, with the goal of identifying potential enhancements and collect feedback from the end users about the functionality.
The UAT kicked off on 16 June and involved 20 organisations - pharmaceutical companies and service providers. Participants tested the import functionality with FHIR XML files they had created themselves conducting the test by accessing the PLM Portal, simulating the application process for an ePI by importing the FHIR file directly within the platform. The testing activities were supported by the Implementation Guide available in the PLM Portal, and walk-in support sessions.
Testing concluded on 27 June, with a positive outcome: the participants were able to successfully import their FHIR files.
The valuable feedback gathered through User Acceptance Testing will be analysed and will inform further development of the FHIR import functionality on the PLM Portal, with the objective of enhancing the process of creating or updating an existing ePI.
Further information on the EU ePI Common Standard can be found in the ePI Implementation Guide, the User Guide for Applicants and in the Guide on validating ePI locally.