The Heads of Medicines Agencies (HMA), the European Commission (EC), the European Medicines Agency (EMA) and a number of pharma companies have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU).
The creation and testing of ePIs in real regulatory procedures is being explored through a one-year pilot initiative: it involves 25 medicines and will conclude in July 2024. The outcomes will inform how to integrate the ePIs into common practice and expand their use across the EU.
The published ePIs are for medicines evaluated by EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden.
The EU ePI Common Standard is available, based on the FHIR standard. ePI will allow third-parties to convert the PI into accessible formats, making it easier to add authorised or supportive video or audio content or other interactive materials.
The ePIs can be viewed at the Product Lifecycle Management Portal in English for centrally approved medicines and in the local language for nationally approved ones: Have a look
ePI data can also be accessed via a public application programming interface where developers can explore the potential of this new format within existing digital platforms. More info