This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU
What is the definition of Product Information (PI) and which documents does it include?
Product information (PI) is defined as documents providing officially approved information for healthcare professionals and patients on a medicine. They consist of the following:
- The summary of product characteristics (SmPC)
- package leaflet (PL)
- labelling
What is electronic Product Information (ePI)?
Electronic Product Information (ePI) is authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the
world wide web, e-platforms and print.
About the electronic Product Information (ePI) Initiative
The ePI initiative was launched to support the digital transformation of healthcare across the EU, and the commitment laid out by the European Commission to prioritise innovations that will empower citizens and build a healthier society. It is also in line with the Euroopean Medicine Agency’s (EMA’s) current digitalisation efforts aiming to make best use of available resources and prepare for future challenges.
What do the key principles of the ePI initiative outline?
The European Medicines Agency, in collaboration with Heads of Medicines Agencies (HMA) and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU.
They outline how ePI will:
- benefit public health
- create efficiency gains for regulatory systems
- align with the existing legislative framework and complement the paper package leaflet;
- fit into the EU’s multilingual environment
- interact with other ongoing digital initiatives at EU and global level.
What are some examples of benefits and functionality that ePI could bring?
- Immediate access to the most recently regulator-approved product information.
- Attractive, presentable and user-friendly interface with other potential supportive features (e.g. user font modification) would motivate patients to take a more active interest in their health status.
- Availability of additional materials to the statutory information: video and audio facilities accessible to support and improve health literacy and safe use of the product.
- Alerts for major updates to the leaflet.
How is it envisaged that ePI will be made available to users?
It is envisaged that ePI will be made available:
- to users (e.g. patients/consumers and HCPs) through websites at EMA level and if available, Member State level.
- for use:
- in other e-health systems, such as electronic health records and e-prescribing systems.
- by third-parties who can reproduce ePI and make it available to patients and HCPs (as is already the case for PI today).
Will ePI supersede or negate the requirement to include a package leaflet in all medicine packs?
No, ePI will not supersede or negate the requirement of the pharmaceutical legislation (Article 58 of Directive 2001/83/EC) to include a PL in the packaging of all medicines or directly convey all information required (by Articles 59 and 62 of the Directive) on the outer or immediate packaging.
Since the current legislation does not require the use of an electronic version of PI, the use of ePI will not constitute a new legal obligation.
About the 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:
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.
Are there any published ePIs available to view?
Yes there are.
EMA and a group of EU national competent authorities tested the use of ePI in a one-year pilot project from July 2023 to July 2024.
The pilot has concluded. Its achievements include:
- Enabling companies to create and manage ePIs during regulatory procedures by using an ePI authoring tool on the Product Lifecycle Management Portal
- Making ePIs created during the pilot publicly available on the portal and via an application programming interface (API)
Updates on ePI progress
EMA makes updated information on ePI available at quarterly public system ‘demo’ events. You can access information on these events via this page.
Timeline of the progress so far
A timeline is provided below. You can also view a summary timeline in this presentation.
| Date | Event/Action |
|---|---|
| July 2023-July 2024 | EMA and a group of EU national competent authorities tested the use of ePI in a one-year pilot project from July 2023 to July 2024. The pilot has concluded. Its achievements include: • Enabling companies to create and manage ePIs during regulatory procedures by using an ePI authoring tool on the Product Lifecycle Management Portal • Making ePIs created during the pilot publicly available on the portal and via an application programming interface (API) |
| 22 Feb 2022 | Report on public consultation on EU Common Standard for electronic product information (ePI) – Summary of comments received and next steps |
| 5 July 2021 | Here is a link to the Information Workshop on electronic Product Information (ePI) held in July 2021. The workshop consisted of presentations providing information on the following: • Background to the ePI initiative • Introduction to the FHIR initiative and description of EU common standard • ePI prototype description and demonstration • Next steps for ePI and roadmap development |
| 1 Jan 2021 – ePI set-up project started | In 2021, EMA, national competent authorities and the European Commission started an ePI set-up project. It aims at developing a common electronic standard for ePI, carrying out a proof-of-concept exercise for implementing the standard and creating a roadmap for implementation across the EU. |
| 29 Jan 2020 – Finalised key principles | The finalised key principles were published on the EMA website and communicated to stakeholders through meetings and dissemination channels. They now represent EMA-HMA-EC guidance on ePI and form the basis of follow-up implementation plans for ePI. |
| 31 Jan 2019 – Draft key principles | The draft key principles from 2018 were the subject of a 6-month public consultation (from 31 Jan – 31 July 2019). Following the consideration of submissions received during the public consultation, the key principles were updated. |
| 28 Nov 2018 -Workshop | This workshop (Nov 2018) brought stakeholders together to discuss their needs and concerns and decide how to move forward with a common approach. The outcome of the workshop was a draft proposal for ‘key principles’, to form the basis of follow-up implementation plans for ePI. |
| 24 Nov 2017 EMA action plan related to the European Commission’s recommendations on product information | The EMA action plan together with the EC report (see above) identified areas where medicines’ product information (PI), which includes the summary of product characteristics (SmPC) and package leaflet (PL), could be improved to better meet the needs of patients and healthcare professionals (HCPs) and proposed actions to address these shortcomings. These wide-ranging actions relate to enhancing readability, improving patient input in development and testing, promoting best practices and developing an electronic format. |
Source: EMA