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Open Consultation for EU common standard on electronic product information- EMA

The European Medicines Agency (EMA) on 8th June 2021 launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.

An EU Common Standard for ePI refers to the technical features of ePI to be agreed upon by regulators and stakeholders. The documentation for the draft EU Common Standard is currently the subject of open public consultation.


The development of electronic product information (ePI) is intended to improve access to up-to-date product information on medicines when and where it is needed.


EU Common Standard for electronic product information (ePI) is authorized, statutory product information for EU medicines (the summary of product characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients/consumers]) in a semi-structured format created using the EU Common Standard.


EMA says ePI is adapted for electronic handling and allows dissemination via the web, e-platforms, and print.


Check out the – key principles in Electronic product information for human medicines in the European Union for more information.

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