Reflection Paper on Patient Access to Electronic Product Information (ePI)
Recommendation
14/15 October 2025
Understanding the Importance of GMP
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A draft reflection paper on patient access to electronic product information (ePI) is available for public consultation. The reflection paper examines 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. The feedback period for this public consultation ends on 30 June 2025.
ePI Pilot Project
The term electronic product information (ePI) for a medicinal product refers to the electronic versions of the summary of product characteristics (SmPC), the labeling and the package leaflet. These documents provide the most important information about the medicinal product for patients/consumers and healthcare professionals.
A pilot project of the EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), was carried out jointly by EMA and four national EU regulatory authorities (Denmark, the Netherlands, Sweden and Spain) from mid-2023 to mid-2024, to generate and publish the ePI in the Product Lifecycle Management (PLM) portal of the European authorities. A summary report on this project was published in December 2024.
Call for Participants: User Testing of FHIR import for ePI
The EMA ePI team is looking for testers able to create their own FHIR XML (Fast Healthcare Interoperability Resources) ePI files compliant with the EU ePI Common Standard to test ePI validation and import into the PLM portal. This is an opportunity to test whether your FHIR ePI is compliant with the standard that will be required by EU regulators in future, and to provide feedback that will be incorporated into ongoing development..
Testers are requested to provide feedback on the following:
- How to create an ePI in FHIR XML format
- How to use the ePI guidance on the PLM portal
- How to use the FHIR ePI implementation guide
- How to import the FHIR into the PLM portal
More details can be found at the EMA website Electronic product information (ePI).
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