03 Dec, 2018
The European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) recently organised a workshop on 28th November 2018 in London to agree with various stakeholders on common European Union key principles to pave the way for implementing electronic product information (ePI) in the EU. Electronic formats are becoming ever more important and bring new opportunities for summary of product characteristics and package leaflets.
The workshop offered a platform for healthcare professionals, patients and consumers, academics, non-profit organisations, regulators and the pharmaceutical industry to discuss:
• opportunities, needs and concerns identified by different stakeholder groups
• ongoing initiatives in the EU
• how ePI fits into other EU and global initiatives
The outcome of this workshop will serve as a basis to draft key principles for the use of ePI in the EU, which will be released for a six-month public consultation in January 2019.