On 10 June 2026, representatives of the State Agency of Medicines (SAM) participated in the European Medicines Agency (EMA) information event “ePI Open Day”, dedicated to the implementation of electronic Product Information (ePI) in the European Union.
During the meeting, EMA presented the latest developments and a draft roadmap for the implementation of ePI (i.e. summary of product characteristics, package leaflet and labelling) within the European Medicines Regulatory Network (EMRN). It was explained that the implementation of ePI is closely linked to the forthcoming EU pharmaceutical legislation, which will introduce significant changes to the preparation, publication and accessibility of product information.
Upon entry into force of the new pharmaceutical legislation, ePI will become a mandatory requirement:
- for new marketing authorisations, ePI will be required immediately at the time of authorisation;
- for already authorised medicinal products, ePI will need to be implemented within three years, with the objective of ensuring ePI for all medicinal products by 2031.
ePI is authorised, statutory product information for human medicines in a semi-structured format created using the EU ePI Common Standard. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.
The implementation of ePI aims to improve the accessibility, quality and usability of product information by ensuring that patients, healthcare professionals and other stakeholders always have access to up-to-date information in digital format.
More detailed information on the ePI initiative is available on the EMA website.
The draft roadmap for ePI implementation is available here.
The SAM encourages marketing authorisation holders to familiarise themselves with the information published by EMA on ePI and to follow further developments in order to ensure preparedness for the upcoming changes.
