Transition to electronic Product Information (ePI): How to be operationally ready to remove the paper insert

This publication provides a comprehensive industry-aligned framework to support the operational transition from paper-based to electronic Product Information (ePI) in pharmaceutical packaging. It outlines practical tools and guidance developed by the BioPhorum Secondary Packaging workstream, including a risk assessment matrix for evaluating carton redesign needs, and a lifecycle process map with defined roles and responsibilities for managing ePI data. The aim is to harmonize practices across the industry and support readiness for market-specific regulatory changes that may mandate or enable the removal of paper inserts.