Electronic product information for human medicines in the European Union – key principles
Human
Data on medicines
Product information
A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about their medicine and its safe use.
The development of electronic product information (ePI) is intended to improve access to up-to-date product information on medicines when and where it is needed.
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.
They 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.