A collaboration between the European Commission (EC), European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has led to the publication of key principles regarding the use of electronic product information (ePI) in the European Union (EU).
ePI refers to electronic versions of the summary of product characteristics (SmPC) for healthcare professionals (HCPs) and the package leaflet (PL) for consumers/patients. The document on key principles stems from an identification of shortcomings in the SmPC and PL. Workshops, draft documents and a stakeholder consultation have culminated in the release of a key principles document which aims to harmonise the approach for ePI across the EU.
The key principles cover the proposed benefits for public health, the potential efficiency gains for regulatory procedures as well as how all of this will comply with the existing legislative framework. Furthermore, the document outlines principles governing the processes involved in implementing ePI along with how this programme interacts with other ongoing initiatives. The importance of ePI being able to support all official EU languages, including Icelandic and Norwegian, in order to benefit all EU citizens is also highlighted.
To read the key principles document in full, click here.