Electronic Product
Information (ePI) in
Europe

Electronic Product Information (ePI) is moving from pilot activity toward broader regulatory use in Europe. Driven by the future EU pharmaceutical framework and EMA’s implementation roadmap, ePI will require marketing authorisation holders to create, validate, submit, and maintain authorised product information in a structured electronic format.

But ePI readiness goes beyond producing a technically valid submission. As electronic product information becomes part of the regulatory lifecycle, organisations need to coordinate regulatory content, product master data, variation processes, multilingual requirements, quality control, and publication channels more closely than in traditional document-centric environments.

This white paper explores the practical implications of this transition. It examines the operational impact of ePI on submission and lifecycle processes, as well as recurring implementation challenges such as content governance, data quality, master-data alignment, multilingual management, validation, ownership, and scalability. It also explains the role of the FHIR-based European ePI approach and considers the options organisations have for creating ePI, from portal authoring and conversion of approved documents to structured-content generation.

Download the white paper to understand what is ahead and how your organisation can build a structured, compliant, and lifecycle-capable approach to ePI.



Author:

-  Christian Mehrmann, Director Solution Portfolio, cormeo