The pharmaceutical world is standing on the brink of a major transformation. The move toward electronic Product Information (ePI) is gathering pace, replacing static, printed inserts with digital, structured content that can be updated, accessed, and shared more easily.
When the Kallik team recently attended the Pharma Packaging & Labeling Innovation Forum in Berlin, it became clear that ePI has become one of the most discussed topics in the industry. For those of us working in labeling, artwork, and regulatory content, it’s not just another compliance change. It’s a complete rethinking of how medical information is created, controlled, and delivered.
What Does ePI Really Mean?
Electronic Product Information uses the same regulated content we already produce, such as the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and labeling details, but it is delivered in a digital and structured format.
Rather than distributing these materials as PDFs or Word files, ePI enables approved content to be published digitally through QR codes on packaging, online portals, or even directly integrated into healthcare IT systems. The European Medicines Agency (EMA) has already piloted ePI submissions to test how this approach can work in practice.
In essence, ePI doesn’t change what we say, but how we say it. It’s a smarter way of storing, managing, and sharing critical medicine information with patients and healthcare professionals.
Why ePI Is Gaining Momentum
Several forces are driving this shift. Regulators are keen to modernize the management of medical information, aiming to make it more accessible, responsive, and sustainable. With ePI, updates can go live almost immediately after approval, eliminating the delays associated with print runs or re-packaging.
For patients, ePI means easier access to accurate and up-to-date information. It can support larger fonts, multiple languages, or even audio for visually impaired users. For healthcare professionals, it ensures they always have access to the most current version of a product’s information.
The move to digital also supports environmental goals, cutting paper use and waste. Most importantly, ePI allows product information to connect with wider healthcare systems, creating a bridge between regulatory content and the digital health ecosystem.
How Does ePI Impact Labeling and Packaging?
The introduction of ePI will significantly reshape how labeling and packaging content is managed. Traditional labeling relies on static documents that are updated manually. ePI, however, uses structured and reusable content components, allowing for faster updates and greater consistency across regions and formats.
This new approach means that updates to product information must appear instantly and consistently across both printed and digital versions. Achieving that requires tighter integration between content management, artwork, and packaging systems, as well as robust version control and validation processes.
Packaging design will also evolve. Many products will soon include QR codes that link directly to the approved digital leaflet. Designers will need to consider placement, readability, and verification to ensure those links always direct users to the correct version.
During the transition, organizations will likely need to maintain both digital and paper versions, which adds complexity but also creates opportunities to streamline processes and improve overall content governance.
What Are the Main Challenges With ePI?
It’s clear there are many benefits to ePI, but it’s no secret that there are some concerns among professionals in the industry about the challenges ePI will bring.
- Regulatory adoption is uneven across regions, and companies worry about inconsistent standards and timelines. Many organizations still rely on legacy document systems, making it difficult to convert years of labeling content into structured, digital formats.
- There are also concerns about validation and compliance. Digital systems must meet the same regulatory standards as printed labeling, including audit trails and data integrity.
- Accessibility remains another key issue, as not all patients have access to digital devices or reliable internet connections.
These are valid concerns, but it’s important to understand that these are not reasons to delay as the benefits significantly outweigh these challenges, which can be overcome with the right preparation and the right software. The transition to ePI will take time, but early adopters will have a significant advantage in building compliant, future-proof labeling systems.
What This Means for Kallik and Our Clients
At Kallik, we’ve always believed labeling is more than artwork creation. It’s about accuracy, compliance, and patient safety. ePI reinforces that view by placing data integrity and content control at the heart of labeling operations.
To prepare, pharmaceutical companies will need to adopt structured content management, ensuring that every label, leaflet, and artwork version originates from a single source of truth. They will also need to integrate digital validation processes to maintain accuracy across printed and electronic formats.
For Kallik and our clients, ePI presents an opportunity to move beyond traditional labeling workflows toward truly connected, data-driven systems. Our experience in automating labeling and artwork approval processes puts us in a strong position to guide companies through this evolution.
How to Start Preparing for ePI
Preparing for ePI begins with understanding where your product information lives and how it moves through your organization. From there, you can assess which systems and processes need to evolve to support structured content and digital publishing.
Running small-scale pilot projects is a practical way to explore ePI-linked packaging or QR code validation while identifying any gaps in workflow or technology. Training teams across regulatory, artwork, and packaging functions will also be vital to ensure everyone understands the implications of the shift.
The transition will not happen overnight, but the direction of travel is clear. Organizations that start now will be far better prepared for when ePI becomes the industry standard.
The Future of Labeling Is Digital
The move to electronic Product Information marks a defining moment for pharmaceutical labeling. It promises faster updates, more accessible information, and improved sustainability. It will also redefine how companies approach compliance and collaboration across departments.
Kallik is ready to support this transformation. Our technology, expertise, and deep understanding of regulated content make us a trusted partner for organizations looking to modernise their labeling operations and prepare for an ePI-enabled future.
Ready to begin your ePI journey?
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