The Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios) has published electronic product information, ePI, for all regulatory procedures in scope for a one-year pilot initiative by European Medicines Regulatory Network. The pilot is to create and test ePI in regulatory procedures. This is a step towards providing information for patients and healthcare professionals in an accessible, electronic, format for medicines.

ePI refers to the authorised, statutory product information for medicines handling in an electronic format for dissemination via the web, e-platforms and in print. Product information includes the summary of product characteristics, the package leaflet and labelling. However the ePI format offers advantages such as improved accessibility, searchability and multilingual capabilities. ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently. 

The creation and testing of ePI in real regulatory procedures is being explored through a one-year pilot initiative by European Medicines Regulatory Network (EMRN). EMRN includes  HMA (Heads of Medicines Agency), EMA and the European Commission (EC). The ePI initiative is an action under the Pharmaceutical Strategy for Europe supported by the EU funding programme EU4Health.

The pilot has published ePI for selected human medicines harmonised across the European Union (EU) for the first time in November 2023. ePI can be viewed at the PLM Portal and ePI data can be accessed via a public application programming interface.
Pilot procedures are still ongoing at EMA and the national authorities in Denmark, the Netherlands, and Sweden. The pilot will conclude in July 2024 and the outcomes will inform the path towards full implementation.