Europe – Key principles for the use of electronic product information for EU medicines

EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) have published today key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the European Union.
The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. These documents accompany every single medicine authorised in the EU and explain how it should be prescribed and used. The package leaflet is provided in the medicine’s box and can also be found, often as a pdf document, on the websites of EU regulators. However, digital platforms open additional possibilities to disseminate the PI electronically. This 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 uptodate information on medicines available at the right time…