Electronic product information for human medicines in the European Union – key principles

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.

Current version

Electronic product information for human medicines in the European Union - key principles

Adopted

Document history

Electronic product information for human medicines in the European Union - key principles

Adopted

Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles'

Electronic product information for human medicines in the European Union - Contributions received following public consultation (partially anonymised)

Electronic product information for human medicines in the European Union - Categorised comments received following public consultation (partially anonymised)

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

Consultation dates: 31/01/2019 to 31/07/2019Draft: consultation closedReference Number: EMA/849614/2018Summary:

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. 

We wish to ask the public whether they agree with the key principles we have identified and whether there is any additional topic that should be reflected. Comments should be submitted via an online form.