Staroveski, Ales, Rey, Manuel, Clay, Miller, Garcia, Eva, Laurent, Fleuret, Arroyo, Fernandito, Boeckxstaens, Jan, Melgar, Estefanía, Carrasco, Eva Maria, Moreno, Mari Carmen, Kiyanitsa, Andrey, Salb, Bernhard and Le Gatt, Alice (2026) Transition to electronic Product Information (ePI): How to be operationally ready to remove the paper insert. BioPhorum.

Abstract

The pharmaceutical industry is steadily moving toward a digital future, with
increasing regulatory support for electronic Product Information (ePI) as a
replacement for traditional paper-based inserts. This shift offers significant
benefits in terms of operational efficiency, improved access to up-to-date
information for patients and healthcare professionals, and supports overall
sustainability goals. However, past experiences—such as the rapid
implementation of ePI during the COVID-19 vaccine rollout—have shown that
sudden regulatory changes can leave companies with limited time to adapt. To
avoid repeating this scenario, this publication aims to align on a common riskbased
approach and harmonized operational practices, so that the industry can
proactively influence the development of globally applicable standards and
ensure readiness for future ePI mandates. Building on BioPhorum’s foundational
2021 publication, “Electronic Product Information in the Pharmaceutical Industry:
Implementation and Solutions Overview from a Packaging Perspective” (1), this
paper incorporates new insights from close collaborations with key stakeholders—
including GS1 Healthcare—and other international initiatives, to support a unified
and forward-looking strategy.

Item Type:	Article
Date Deposited:	14 Apr 2026 00:45
Last Modified:	14 Apr 2026 00:45
URI:	https://oak.novartis.com/id/eprint/59641