European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)
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The objectives of this joint workshop are to agree with all stakeholders on common key principles for the use of electronic summary of product characteristics (SmPC) and package leaflet formats in the European Union (EU) and create a draft proposal of these key principles for public consultation.
The European Commission, HMA and EMA are working together to facilitate the development of electronic tools to improve access of patients and healthcare professionals to product information in the EU. Electronic formats bring new opportunities for summary of product characteristics and package leaflets.
As more Europeans gain access to information technologies, it is important to agree with all stakeholders on common key EU principles as to how electronic formats can be used to provide product information to EU citizens in accordance with existing legislation.