Electronic product information (ePI)

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:

• EU4Health programme 2021-2027 – a vision for a healthier European Union

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:

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:

• Enabling companies to create and manage ePIs during regulatory procedures via the Product Lifecycle Management Portal
• Making ePIs created during the pilot publicly available on the portal and via an application programming interface (API)

To access the ePIs, see: 

• Published ePIs (Product Lifecycle Management Portal)
• Application programming interface for ePIs

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 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 PLM portal)

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.

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