ePI - Open for consultation: reflection paper on accessing ePI from medicine package
A reflection paper, currently open for public consultation, outlines considerations for linking to ePI by scanning a code on the medicine package. Comments can be submitted before end June 2025
date: 01/04/2025
The goal is to provide patients, consumers, and healthcare professionals with direct access to the most current and relevant information on a medicine’s safety, benefits, and usage, ensuring that patients and healthcare professionals have the right information when needed. This will support informed decision-making by patients and healthcare professionals and improve patient safety overall.
A reflection paper, currently open for public consultation, outlines considerations for accessing ePI by scanning a code on the medicine package. The paper proposes that ePI, in particular the package leaflet, displayed in html format, should be available via straightforward scanning of the medicine package.
In order to support meaningful, patient-friendly solutions, the pharmaceutical industry is encouraged to lead and maintain a cross-company initiative providing access to information with wide coverage of a large number of EU medicines.
Regulators are encouraging and supportive of any future industry-led initiative to create a solution for medicines with EU-wide coverage. Importantly, early action on an EU-wide solution will promote an optimised user experience for patients and healthcare professionals, with equality of access to ePI throughout Europe.
Comments on the reflection paper can be submitted until the end of June 2025.
Following the close of the consultation, comments received will be processed and final version of the paper will be published on the EMA website for public reference.