electronic product information

Formal Definition

ePI is authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print. ePI fulfils the key principles.

EMA HMA Electronic product information for human medicines in the EU: key principles 2019
  • Abbreviation(s): ePI
  • Categories: Regulatory