The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission on Wednesday released a set of principles for a harmonized approach to electronic product information (ePI) for medicines in the EU.
In the EU, product information (PI) consists of a package leaflet included in a drug’s packaging and summary of product characteristics (SmPC). “These documents accompany every single medicine authorised in the EU and explain how it should be prescribed and used,” EMA writes.
While some medicines have electronic package leaflets available, EMA says these are not interoperable with other electronic health systems and fail to address other patient and healthcare provider needs.
The release of the principles comes after the European Commission identified electronic product information as a way to improve how EU citizens access information about medicines in 2017 and an EMA workshop on the matter in 2018. EMA says it received more than 500 comments from stakeholders during the ensuing public consultation…