EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) have launched a six-month public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.

Stakeholders and members of the public are invited to submit comments on these key principles via an online form until 31 July 2019.

The product information (PI) of a medicine in the EU 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 used and prescribed. The package leaflet is currently provided in the medicine’s box and can also be found, mainly as a pdf document, on the regulators’ websites. However, digital platforms open additional possibilities to disseminate the PI electronically. This can address some of the current limitations and better meet patients’ and healthcare professionals’ needs for accessible, up-to-date information on medicines at the point of need.

Following the consultation, the final version of the key principles will be agreed. They will then form the basis to support a harmonised approach to ePI across the EU.