EMA Consultation: Electronic product information for human medicines in the European Union – draft key principles

EMA Consultation: Electronic product information for human medicines in the European Union – draft key principles

The European Medicines Agency (EMA) has launched a six-month public consultation on draft key principles for Electronic Product Information (ePI) for human medicines in the EU.

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 product information (PI) of a medicine in the EU includes the package leaflet for patients and the summary of product characteristics for healthcare professionals. As more Europeans gain access to information technologies, digital platforms open additional possibilities to disseminate the PI electronically improving 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 formThe consultation will remain open until July 31, 2019.

Moreover, a report from the EMA/HMA/EC workshop on ePI which took place on 28 November 2018 and the video from this workshop are available at this page.

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