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NEWS | Spanish Medicines Agency Launches ePI Pilot Initiative!

May 28, 2024

The Spanish Medicines Agency (AEMPS) has published electronic product information (ePI) for all regulatory procedures as part of a one-year pilot initiative by the European Medicines Regulatory Network (EMRN). This pilot aims to create and test ePI in real regulatory procedures, marking a significant step towards providing accessible and electronic information for patients and healthcare professionals.

What is ePI?

ePI refers to the authorised, statutory product information for medicines in an electronic format for dissemination via the web, e-platforms, and in print. It includes:

  • Summary of Product Characteristics
  • Package Leaflet
  • Labelling

 

Advantages of ePI:

  • Improved Accessibility: Easier for patients and healthcare professionals to access information.
  • Enhanced Searchability: Quickly find relevant information.
  • Multilingual Capabilities: Available in multiple languages.
  • Integration with Healthcare Systems: Seamless access to up-to-date product information.

 

About the Pilot Initiative:

The creation and testing of ePI in real regulatory procedures are being explored through this one-year pilot by EMRN, which includes HMA, EMA, and the European Commission. The ePI initiative is part of the Pharmaceutical Strategy for Europe and is supported by the EU funding program EU4Health.

In a milestone achievement, AEMPS has published ePI for all regulatory procedures in the Spanish pilot. ePI for selected human medicines harmonised across the EU was first published in November 2023 and can be viewed at the PLM Portal, with ePI data accessible via a public application programming interface.

Ongoing and Future Steps:

Pilot procedures are ongoing at EMA and national authorities in Denmark, the Netherlands, and Sweden. The pilot will conclude in July 2024, and its outcomes will inform the path towards full implementation.

Stay tuned for more updates on this transformative initiative!

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