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Electronic product information (ePI)

EMA
2026/08/28

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:

Updates on ePI progress

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:

Quarterly system demo events

ePI user acceptance testing: call for participants

EMA is inviting testers representing pharmaceutical companies to participate in a user acceptance testing (UAT).

This testing covers the main functionalities of the electronic product information (ePI) project.

It aims to test relevant business scenarios for the creation, management and submission of ePI within the product lifecycle management (PLM) portal. This is also meant to evaluate the general usability of the portal.

Testers provide their feedback on the following aspects:

  • Test results for available functionalities
  • User experience of ePI tooling at the PLM portal
  • Available guidance and training materials

You can sign up by 18 September 2026 to participate in this testing via the survey below:

Patient access to ePI

A draft reflection paper on patient access to electronic product information (ePI) was 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.

Stakeholders were able to provide their input between March and June 2025.

Draft Reflection paper on linking to electronic product information (ePI) from EU medicine packages

Draft: consultation closed

Consultation dates:

31/03/2025

to

30/06/2025

Reference Number:

EMA/95076/2025

Summary:

Comments should be provided using the EUSurvey form. For any technical issues with the form, please contact the EUSurvey Support.

English (EN) (351.56 KB - PDF)

First published:

31/03/2025

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Pilot project to test ePI

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:

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.

Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines

English (EN) (1.22 MB - PDF)

First published:

16/12/2024

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EU ePI Common Standard and Fast Healthcare Interoperability Resources (FHIR)

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:

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:

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

English (EN) (753.47 KB - PDF)

First published:

22/02/2022

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

English (EN) (186.42 KB - XLSX)

First published:

22/02/2022

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

Reference Number:

EMA/680018/2017

Summary:

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.

English (EN) (134.58 KB - PDF)

First published:

15/11/2017

Last updated:

15/11/2017

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Draft roadmap

A draft roadmap is available to ensure a timely and coordinated delivery of ePI across the EU medicines regulatory network.

This is in line with upcoming legal requirements under the new pharmaceutical legislation.

EMA and the Network made this draft roadmap available in March 2026.

Electronic product information (ePI) roadmap

English (EN) (220.98 KB - PDF)

First published:

20/03/2026

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Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

See update history

28 August 2026

Section on 'ePI user acceptance testing: call for participants' created.

20 March 2026

Section on a 'draft roadmap' for the ePI created.

Related content

External content

Summary

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).