European Medicines Regulatory Network Adopts EU Common Standard for Electric Product Information

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

The European Medicines Regulatory Network has adopted a Common Standard for the electric product information (ePI) on medicines in the EU on Feb. 22, 2022. 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.

The product information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. Every single medicine authorized in the EU includes these documents that help explain how it should be used and prescribed.

The adoption of the Common Standard will allow for the spread of unbiased, up-to-date information on all medicines available to patients in the EU. The EU ePI Common Standard will provide the ability to harmonize electronic information on medicines within the EU and improve the delivery of information for patients, consumers, and healthcare professionals for better decision making. The ePI can be updated immediately as new information becomes available and can be personalized to be more easily accessible to users with diverse abilities.

Source: EMA