EMA Preps for Better Electronic Delivery of Package Leaflets, Product Information

Regulatory NewsRegulatory News | 21 November 2018 |  By 

Next Wednesday, the European Medicines Agency (EMA) is holding a workshop with the Heads of Medicines Agencies and European Commission to discuss the various ways to implement electronic product information (ePI) in the EU.

EMA said the outcome of the 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.

Currently, product information of a medicine, which includes the package leaflet and the summary of product characteristics, is provided in paper form and attached to each medicine dispensed in the EU.

The workshop follows the recent release of an EC report exploring how electronic access to product information could improve the way EU citizens access medicines information. For instance, EMA notes that although the package leaflet is available in PDF format on regulators’ websites, novel digital platforms could open additional possibility to disseminating package leaflets electronically.

“This can enhance access to up-to-date information and offer new opportunities to better tailor this information to the needs of patients. In addition, ePI will support patients with visual impairments and citizens with low literacy levels,” EMA said.

The workshop offers a platform for stakeholders, including health professionals, nonprofits, regulators and the pharmaceutical industry to discuss: opportunities, needs and concerns, ongoing initiatives in the EU and how ePI fits into other EU and global initiatives.

The workshop will also discuss initiatives to make the package leaflet easier to understand, how to strengthen patients’ input into the preparation of the leaflet and how to update EU guidance and the sharing of best practices on preparing the leaflets.

EMA also notes that the timelines of these activities may need to be adjusted in view of EMA's business continuity plan in the context of Brexit and the agency's relocation to the Netherlands.



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