Added on 22 April 2025:
'FHIR import testing: open call for participants' section
Electronic product information (ePI) refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print.
Transitioning to ePI offers advantages such as improved accessibility, searchability and multilingual capabilities.
ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.
The ePI initiative is supported by the EU funding programme EU4Health:
EMA makes updated information on ePI available at quarterly public system 'demo' events.
Select the expandable panel below (via the arrow symbol) to access event pages featuring insight such as meeting agendas and video recordings for individual quarterly system demos:
A draft reflection paper on patient access to electronic product information (ePI) is available for public consultation.
The reflection paper explores how patients, consumers and healthcare professionals across the EU can access up-to-date information on medicines safety, benefits and conditions of use, in their preferred language where available.
It outlines a proposal for accessing the ePI of a medicine by using a smart phone to scan a two-dimensional code printed on medicine packages.
You can send your feedback to this public consultation by 30 June 2025 via the form available below:
EMA and a group of EU national competent authorities tested the use of ePI in a one-year pilot project from July 2023 to August 2024.
Its achievements include:
To access the ePIs, see:
The pilot covered both centralised and national regulatory procedures.
Participating countries included Denmark, the Netherlands, Spain and Sweden.
A detailed report with the results of the pilot is available below. It includes recommendations for integrating ePI into regulatory procedures.
ePI uses a semi-structured format, based on a common electronic standard for product information.
The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR).
This technical standard describes data formats and elements, and an application programming interface for exchanging electronic health records.
The European medicines regulatory network has adopted the EU ePI Common Standard to support the provision of harmonised electronic information on medicines within the EU.
For more information, see:
EMA is inviting testers to participate in a user acceptance testing of FHIR import of ePI.
The FHIR import functionality enables users to import electronic product information in FHIR XML format directly into the PLM portal.
EMA is asking testers to create their own test files in XML format.
As testers, provide your feedback on:
Express your interest in participating in the FHIR testing by 19 May 2025, via the EU survey link below:
For more information, see:
EMA, the Heads of Medicines Agencies (HMA) and European Commission published key principles to guide the development and use of ePI for human medicines in the EU in 2020.
For more information: