Electronic product information for human medicines in the European Union – draft key principles
Table of contents
A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about safe use. The development of electronic product information (ePI) is intended to improve access to up-to-date product information when and where it is needed. The European Medicines Agency, in collaboration with Heads of Medicines Agencies and the European Commission, has developed some key principles through stakeholder consultations to guide future development of ePI for medicines in the EU.
Stakeholders and members of the public are invited to submit comments on these key principles and any additional topic that should be reflected via an online form.