EU Agencies Outline Approach to Electronic Product Information

Regulatory NewsRegulatory News | 29 January 2020 |  By 

The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission on Wednesday released a set of principles for a harmonized approach to electronic product information (ePI) for medicines in the EU.
In the EU, product information (PI) consists of a package leaflet included in a drug’s packaging and summary of product characteristics (SmPC). “These documents accompany every single medicine authorised in the EU and explain how it should be prescribed and used,” EMA writes.
While some medicines have electronic package leaflets available, EMA says these are not interoperable with other electronic health systems and fail to address other patient and healthcare provider needs.
The release of the principles comes after the European Commission identified electronic product information as a way to improve how EU citizens access information about medicines in 2017 and an EMA workshop on the matter in 2018. EMA says it received more than 500 comments from stakeholders during the ensuing public consultation.
Within the 18-page key principles document, the agencies define what a harmonized ePI would be and explain how a common electronic standard would benefit patients, increase regulatory efficiency and fit within the existing legislative framework for product information.
The document defines ePI as the “authorized, statutory product information for medicines (i.e. SmPC, PL and labeling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print.”
Going forward, EMA says the first step will to be to agree on and develop a common standard that will fulfill the needs for ePI across the EU to avoid generating “unnecessary complexity.”
According to the document, ePI would benefit patients by making updated PI available more quickly and allow for greater accessibility for patients with disabilities. “Current PDF and print copy formats of PI do not well serve all citizens equally, given the wide range of abilities throughout society,” the document states.
The document also suggests that providing ePI would not be a legal obligation as electronic PI is not required under current EU legislation and that ePI would not supersede or negate any requirements under Articles 58, 59 and 62 of Directive 2001/83/EC for package leaflets and information on outer or immediate packaging.
Additionally, the document details how a system for ePI would be implemented and governed, as well as how ePI would interface with other EU and global eHealth initiatives.
EMA says the principles have already been endorsed by its Management Board and the HMA and are “expected to be followed by all parties involved in the process of developing and implementing ePI for medicines across the EU.”


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