Roadmap for the Introduction of the Electronic Package Leaflet

The European Medicines Agency (EMA) has published a draft plan for the introduction of electronic product information. The roadmap outlines the stages of ePI implementation from 2026 onwards. It includes technical preparations, a phased roll-out and a central EU portal for displaying the information.

Background

'Electronic Product Information' (ePI) refers to the authorised, legally required product information for medicinal products, including the Summary of Product Characteristics (SmPC), package leaflet and labelling, which has been adapted for electronic processing and distribution via the internet and electronic platforms, as well as in printed form.

Switching to ePI offers benefits such as improved accessibility, searchability and multilingualism. ePI can also be integrated into electronic health systems, providing healthcare professionals and patients with more convenient access to accurate, up-to-date product information.

The draft roadmap for the implementation of electronic product information outlines the planned development stages for 2026, the phased introduction of centrally authorised medicinal products (CAPs) and nationally authorised products (non-CAPs), the implementation process and the future public provision of ePIs.

For CAPs, a voluntary, phased go-live is planned following industry user acceptance testing (UAT):

• Q4 2026 for vaccines,
• H1 2027 for oncology products and
• H2 2027 for all other CAPs

For non-CAPs, a survey of the relevant National Competent Authorities (NCAs) and a Readiness Assessment are planned for 2027, followed by national implementation in 2027/2028.

The launch of the implementation is not intended to disrupt ongoing evaluation procedures. In the future, as well as submitting Word/PDF documents, applicants will create or upload the ePI via the PLM Portal. Once product information is available electronically, it will remain so for all subsequent variations. For CAPs, the initial ePI must be created in English. Additional languages are optional, with full multilingual support to follow at a later date.

The information will be made available to the public via the European Medicines Web Portal (EMWP) in future. Until the EMWP is available, the relevant EPAR page on the EMA website will serve as an interim solution for CAPs. NCAs may also use their own national websites for NAPs. In the future, all ePIs will be freely available to third parties.

Further details of the roadmap can be found on the EMA website.