In the EU, ePI follows the EU ePI Common Standard, which is based on the FHIR data standard and has been adopted by the European medicines regulatory network. EMA ran an ePI pilot from July 2023, which published 23 ePIs for centrally and nationally authorized medicines. EMA has since published guidance on submitting ePI and a draft roadmap for phasing it in for centrally authorized products. Submission is voluntary for now, and it doesn't replace the Word and PDF product information annexes submitted in eCTD. A QR code or link on the pack is a way to reach ePI, not ePI itself. See also package leaflet.
Why it matters for labeling
The printed and electronic versions of the same content have to match and stay in step. Because ePI is structured data, the text is processed by machines, so errors such as encoding problems, formatting artifacts or missing sections can travel straight into what patients and professionals see. Where a pack carries a link or code to the electronic version, it has to lead to the current one.
Common mistakes
- Electronic and printed versions that differ after a variation
- A structured file converted from a Word document without checking the text
- A link or code on the pack that points to an outdated version
- Assuming ePI replaces the paper leaflet, which depends on the Member State and isn't the case today