Electronic product information (ePI)

The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic product information (ePI) for human medicines in the European Union (EU). 

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.

Pilot project to test ePI

EMA and a group of EU national competent authorities are testing the use of ePI in a one-year pilot project from July 2023. 

Update: During the pilot, companies create and manage ePIs during regulatory procedures, using an ePI authoring tool on the Product Lifecycle Management Portal. Once approved and published by regulators, the ePIs are publicly available on the portal and via an application programming interface (API). To access the ePIs:  Published ePIs (Product Lifecycle Management Portal) Application programming interface for ePIs

The pilot covers both centralised and national regulatory procedures. 

Participating countries include Denmark, the Netherlands, Spain and Sweden.

Updated information on the pilot's progress is made available at quarterly public system 'demo' events:

• Quarterly System Demo – Q3 2023 (21/09/2023)
• Quarterly system demo - Q2 2023 (22/06/2023)
• Quarterly system demo - Q1 2023 (22/03/2023)
• Quarterly system demo - Q4 2022 (21/12/2022)
• Quarterly system demo - Q3 2022 (28/09/2022)

This pilot is supported by the EU funding programme EU4Health.

EU ePI Common Standard

ePI uses a semi-structured format, based on a common electronic standard for product information.

The EU ePI Common Standard is available, based on Fast Healthcare Interoperability Resources (FHIR), a technical standard describing data formats and elements and an application programming interface for exchanging electronic health records:

• EU ePI Common Standard (on GitHub)

The EU ePI Common Standard has been adopted by the European medicines regulatory network to support the provision of harmonised electronic information on medicines within the EU.

Development of ePI

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: 

• Electronic product information for human medicines in the European Union – key principles

Report on public consultation on EU Common Standard for electronic product information (ePI) - Summary of comments received and next steps

EU Common Standard for electronic product information (ePI) - categorised comments received following public consultation

European Medicines Agency action plan related to the European Commission’s recommendations on product information

Reference Number: EMA/680018/2017Summary:

The European Medicines Agency (EMA) recognises the importance of the European Commission report and its recommendations to improve the European Union (EU) product information. This represents a unique opportunity to improve the information EU patients receive on their medicines, within the boundaries of the current legislation.