EMA publishes principles of electronic product information

The European Medicines Agency (EMA) has launched its principles explaining how EU Member States can work towards an international standard electronic product information system.

EMA collaborated with the European Commission (EC) and the Heads of Medicines Agencies (HMA) to prepare the principles. They say moving to an electronic product information (ePI) system:

“…can address some of the current limitations (e.g. the current PI is not interoperable with other electronic health systems such as e-prescription and electronic health records) and better meet patients’ and healthcare professionals’ needs for accessible, trustworthy and up-to-date information on medicines available at the right time.”

The principles describe the integration of ePI into existing process and law, and how ePI would work with, or replace, the summary of product characteristics (SmPC) and package leaflet.

Read more and download Key principles for the use of electronic product information for EU medicines here.

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Published on 31. January 2020 in News, News EU