Electronic product information (ePI) for European Union (EU) medicines will benefit patients and healthcare professionals (HCPs) by providing up-to-date information on safe and effective use at the point of need.

It contributes to the objectives of the European Medicines Agencies Network Strategy, the European Medicines Agency (EMA) Regulatory Science Strategy and the European Commission (EC) Pharmaceutical Strategy for Europe.

Achievements to date include adoption of a harmonised standard for ePI, the EU ePI Common Standard, by the European medicines regulatory network (EMRN), development of tooling for ePI creation and management, and the conclusion of a one-year pilot, the subject of this report. The ePI initiative is supported by the EU funding programme EU4Health.

 

ePI pilot report :Experience gained from creation of ePI during regulatory procedures for EU human medicines