Electronic Product Information (ePI)
The patient information leaflet provides patients with essential information on how to use their medicine. In today’s digital age, traditional print and PDF formats for medicinal product information are becoming less effective. Consequently, ePI has been developed, an electronic format that modernises the way patients and healthcare professionals access medicines information. The MEB is honoured to be at the forefront of this initiative, working in collaboration with other national medicines agencies in Europe, the EMA, and various stakeholders to implement ePI.
Definition and standard
Electronic product information (ePI) is authorised, statutory product information for medicines. It includes the patient information leaflet and the Summary of Product Characteristics for the healthcare professional. ePI has a semi-structured format at the level of the text headings which uses the common EU electronic standard. It is adapted for electronic handling and allows dissemination via the internet and healthcare information systems, while still offering the option to print.
In 2020, the European Medicines Regulatory Network established the 'Key principles for ePI', setting the foundation for the development of ePI. The common EU electronic standard for ePI, adopted in 2021, is based on the widely-used healthcare technical standard, FHIR, ensuring efficient access to product information for both patients and healthcare professionals.
Enhancing healthcare with ePI
With ePI, updates can be made instantly as new information emerges. Its structured nature enables the adaptation of product information to individual needs, accommodating users with diverse skills. Future ePI developments of the ePI may encompass automatic update notifications, supplementary video or audio content, and online reporting tools for adverse events.
Pioneering ePI creation and provision
An ePI Authoring portal has been developed to facilitate the creation, publication, and provision of ePI. The MEB is involved in the pilot project to create ePI according to the common standard within this portal, covering both European and nationally authorised medicinal products for human use.
The ePI Authoring portal, located on the Product Lifecycle Management portal, enables ePI creation prior to submission and storage in a repository following approval of the text. An application programming interface (API) subsequently makes the approved ePI available for display on websites, healthcare information systems, personal health environments and apps. Pilots are scheduled for 2023 and 2024, and will take place in the Netherlands, Spain, Denmark, Sweden and Malta. These are coordinated by the national medicines agencies. The MEB is carrying out a pilot for a limited number of procedures at the national level. The EMA is conducting a pilot for centralised procedures.
Connecting to the health information system
The MEB is conducting exploratory discussions with various healthcare parties in the Netherlands to ensure a smooth integration of ePI with the Dutch health information system. This process involves examining the position of ePI within the Dutch healthcare data infrastructure and analysing data exchange scenarios in the context of the Medication Process where ePI provides added value.
For further information about ePI, please contact the project team at ePI@cbg-meb.nl.