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EU adopts electronic product information standard for medicines

The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information (ePI) on medicines in the European Union (EU).

According to the European Medicines Agency (EMA), the standard will enable the wider dissemination of unbiased, up-to-date information on all medicines available to patients in the EU through an expanding range of electronic channels.

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and, according to the EMA, is a step towards improved delivery of information for patients, consumers, and healthcare professionals.

The ePI can be updated immediately with new information. The structured nature of ePI will also offer new opportunities to personalise the product information to individual needs and to make it more easily accessible to users with diverse abilities, said EMA. Future developments of the ePI could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools

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