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EMA Guidance: Electronic product information (ePI) submission during centralised procedures
As medicines move toward electronic formats, accurate and up-to-date product information is increasingly important. The European Medicines Agency (EMA) has issued guidance, "Electronic product information (ePI) submission during centralised procedures," explaining how applicants should submit, create, update, and maintain electronic product information (ePI) for centrally authorised medicinal products. The guidance provides practical instructions for managing ePI through the
Sharan Murugan
Sep 55 min read
EMA’s Reflection Paper: Linking to ePI from EU Medicine Packages – A Digital Leap in Patient Information
The European Medicines Agency (EMA) published on 31 March 2025 a draft " Reflection paper on linking to electronic Product Information...
Sharan Murugan
Apr 5, 20254 min read
EU Common Standard for electronic Pproduct Information
ePI refers to medicines' authorised, statutory information (including summary of product characteristics, package leaflet and labeling)...
Sharan Murugan
Mar 3, 20221 min read
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...
Sharan Murugan
Jun 13, 20211 min read