The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU).
The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and is a step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making.This will pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels.
The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. These documents accompany every single medicine authorised in the EU and explain how it should be used and prescribed.
The ePI can be updated immediately, as soon as new information becomes available. The structured nature of ePI will also offer new opportunities to personalise the product information to individual needs and to make it more easily accessible to users with diverse abilities. Future developments of the ePI could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools.
Developing the common standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), National Competent Authorities (NCAs) and the European Commission (EC) in 2021.
A follow-on pilot project supported by the EU’s funding programme EU4Health will develop tools and guidance to pilot the use of ePI prior to implementation.