European Union Adopts a Common Standard for Electronic Information about all Medicines in the Region

Residents in the European Union will soon have access to a single electronic database with information about all medicine available in the region, following the European Medicines Regulatory Network’s adoption of a common standard for electronic product information (ePI). 

“This will enable any EU resident to get up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels,” according to the European Medicines Agency on Tuesday.

This information will include the package insert for patients on how the product should be used and the summary of product characteristics (SmPC) for healthcare professionals, explaining how it should be prescribed. 

“The EU ePI Common Standard will support the provision of harmonised electronic information on medicines within the EU and is a step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making,” according to the EMU.

It added that developing the common standard was one of the key deliverables of an ePI project run by the European Medicines Agency (EMA), National Competent Authorities (NCAs) and the European Commission (EC) in 2021.

A follow-on pilot project supported by the EU’s funding programme EU4Health will develop tools and guidance to pilot the use of ePI prior to implementation. 


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