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EMA publishes electronic product information for human medicines

Published on: 08 November 2023
Published by LNB News

LNB News 08/11/2023

Document Information

Issue Date: 08 November 2023

Published Date: 08 November 2023

Jurisdiction(s): European Union

Article summary

The European Medicines Agency (EMA) has published electronic product information (ePI) for selected human medicines. In line with the EU ePI Common Standard, the ePIs aim to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms. A one-year pilot has been launched to create and test ePIs and enable the transition to the electronic system for medicines evaluated nationally and at a European level. The ePIs, containing a summary of the medicine’s characteristics, labelling and package leaflet, accompany every authorised medicine in the EU and explain how they should be used and prescribed. Future developments could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction.

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