EU Medical Agencies Defines Key principles for the use of electronic product information (ePI)
The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC) have published Key principles outlining a harmonised approach to develop and use of ePI – electronic product information.
In the European Union (EU), a medicine’s product information (PI), which includes the summary of product characteristics (SmPC, intended for healthcare professionals [HCPs]), labelling (outer and inner packaging information) and package leaflet (PL, for patients / consumers and generally included as a printed copy in the medicines package1), is a pivotal source of regulated and scientifically validated information that assists HCPs in prescribing and dispensing the medicine and informs patients and consumers about its safe use.
The ePI initiative was launched to support the digital transformation of healthcare across the EU, and the commitment laid out by the European Commission to prioritise innovations that will empower citizens and build a healthier society.
The document defines ePI as the “authorized, statutory product information for medicines (i.e. SmPC, PL and labeling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print.”
The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU.
The EU outline how ePI:
- benefits public health;
- creates efficiency gains for regulatory systems;
- aligns with the existing legislative framework and complements the paper package leaflet;
- fits into the EU’s multilingual environment;
- interacts with other ongoing digital initiatives at EU and global level.
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