First Electronic Product Information (ePI) for Human Medicines

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU).
The product information of a medicine includes the following: 

  • The Summary of Product Characteristics (SmPC),
  • The Labelling,
  • The Package Leaflet (PL).

These documents accompany every medicine authorized in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators, with a printed package leaflet usually also provided in the medicine's box.

One-Year Pilot Project

Digital platforms open new possibilities to share information electronically, keep it constantly updated and make it more accessible to end users such as healthcare professionals and patients. Thus, the EMA and a group of EU national competent authorities are testing the use of ePI in a one-year pilot project from July 2023. During the pilot, companies create and manage ePIs during regulatory procedures, using an ePI authoring tool on the Product Lifecycle Management Portal. Companies participating in the pilot create and submit the ePI as part of their regulatory application (the pilot covers both centralized and national regulatory procedures). The ePIs can then be viewed at the Product Lifecycle Management Portal in English for centrally approved medicines and in the local language for nationally approved ones. Testing is ongoing to allow access to ePIs in all EU languages. Participating countries include Denmark, the Netherlands, Spain and Sweden.

Does this mean the End of the Printed Package Leaflet?

Once approved and published by regulators, the ePIs are publicly available on the portal. In addition, ePI data can be accessed via a public application programming interface (API) where developers can explore the potential of this new format within existing digital platforms. The pilot will end in July 2024, and the outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU. Future developments could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools.

More information is available in the EMA communication: First electronic product information (ePI) published for selected human medicines.

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