Electronic Product Information (ePI) is becoming a practical implementation topic for marketing authorisation holders across Europe. Driven by the future EU pharmaceutical framework and EMA's implementation roadmap, ePI will move from pilot activity toward broader regulatory use over the coming years. The first operational focus will be on creating, validating and submitting ePI through the European regulatory infrastructure.
But the strategic challenge goes beyond submission readiness. ePI introduces a new operating requirement for managing authorised product information in a structured, consistent and lifecycle-capable way. Organisations will need to coordinate regulatory content, product master data, variation processes, multilingual requirements and publication channels more tightly than in today's document-centric environments.
This white paper explores what this shift means in practice — examining the operational impact and key challenges organisations face as ePI requirements take hold, the technology and solution considerations needed to support a structured, lifecycle-capable approach, and, ultimately, how to create ePIs within this evolving regulatory landscape.
Download the white paper to understand what's ahead — and how to prepare.
Authors
- Christian Mehrmann, Director of Solution Portfolio, cormeo
