Key principles for harmonised approaches to develop and use electronic product information (ePI) for human medicines across the European Union

EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) have published key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the European Union.

The key principles derive from extensive discussions and consultations carried out in 2018 – 19 by EMA, HMA and the EC with representatives of all stakeholder groups concerned, from patients, healthcare professionals and regulators to the pharmaceutical industry.

ePI is intended to facilitate dissemination of the medicines’ package leaflet and summary of product characteristics electronically, be 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.

More information is available in the press release on the EMA website.

For more information on the European regulatory system for medicines, please click here(available in official EU languages).

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