EU ePI Guide: Preparing Pharmaceutical Packaging for Electronic Product Information
The European Union is accelerating the digital transformation of pharmaceutical product information. One of the key initiatives in this shift is Electronic Product Information (ePI), led by the European Medicines Agency (EMA). As ePI moves from pilot programs toward broader adoption, pharmaceutical manufacturers are beginning to reassess how product information is delivered and accessed—particularly through physical packaging linked to digital content.
This article explains what EU ePI is, why it matters, how QR codes are used to access electronic leaflets, and what this means for coding, marking, and labeling on pharmaceutical production lines.
What Is EU ePI (Electronic Product Information)?
Electronic Product Information (ePI) refers to the authorized medicinal product information—such as the Summary of Product Characteristics (SmPC), Package Leaflet (PL), and labeling—made available in a structured, electronic format rather than only as paper inserts or static PDFs.
Under the EMA framework, ePI is designed to:
• Improve patient and healthcare professional access to up-to-date product information
• Enable faster updates compared to printed leaflets
• Support multilingual access across EU member states
• Facilitate integration with digital healthcare systems
In practical terms, EU ePI is often described as a digital or electronic package leaflet, where official medicinal product information is accessed online rather than solely through paper inserts included in the box.
Why the EMA Is Promoting ePI: Regulatory Context and Direction
The shift toward electronic product information (ePI) is driven by clear limitations in traditional paper-based pharmaceutical leaflets.
According to the European Medicines Agency, printed package leaflets are difficult to keep up to date, constrained by physical space, and increasingly complex to manage across multiple EU languages. These challenges reduce accessibility for patients and healthcare professionals and make rapid safety updates harder to implement.
To address these issues, the EMA is promoting EU ePI as a digital, structured format for authorized medicinal product information, enabling faster updates, improved accessibility, and better alignment with EU digital health and sustainability objectives.
To support practical adoption, the EMA and EU national authorities have launched ePI pilot projects within real regulatory procedures. These pilots focus on:
• Standardized electronic product information formats (EU ePI Common Standard)
• Trusted publication of official product information
• Digital access for patients and healthcare professionals
• Interoperability with EU healthcare and regulatory systems
The EMA has stated that these pilots are intended to “pave the way for future implementation of ePI across the EU,” signaling a clear regulatory direction—even though ePI is not yet mandatory for all medicines.
How Patients Access ePI: 2D Codes on Medicine Packaging
A key practical question is how patients and healthcare professionals access electronic product information in real life.
In many industry implementations and pilot projects, 2D codes—such as QR codes or GS1 DataMatrix—have been used to link packaging to electronic product information.
By scanning a 2D codes printed on the medicine packaging, users can be directed to an official ePI webpage that displays:
✔️ The current package leaflet
✔️ Safety updates
✔️ Multilingual versions
✔️ Additional regulatory information
In this model, pharmaceutical packaging becomes the physical access point to trusted digital product information, while the content itself remains centrally managed and kept up to date.
This 2D code does not replace mandatory product identifiers used for serialization or traceability. Instead, it functions as a digital access point, complementing existing regulatory markings.
Preparing Pharmaceutical Packaging for ePI with Hanin Marking and Labeling Solutions
As pharmaceutical regulations evolve, manufacturers are looking for future-ready coding and labeling solutions that support both current compliance needs and upcoming digital initiatives such as ePI.
Hanin provides efficient and reliable coding, marking, and labeling solutions for pharmaceutical and healthcare packaging environments, including:
• Thermal transfer overprinters for flexible packaging, films, and pouches, where durability and contrast are critical
• Thermal transfer printers for cartons, cases, and compliance labels that require clear QR codes alongside batch numbers and expiry dates
These solutions support QR codes, GS1 DataMatrix, and other 2D barcodes, as well as variable data printing such as batch numbers. With 300 dpi or higher resolution, they ensure that even small QR codes printed on paper labels or outer packaging remain easy to scan.
Designed for stability, durability, and system compatibility, Hanin solutions are well suited for regulated, high-reliability pharmaceutical production lines.
By enabling accurate and consistent 2D code printing and labeling, Hanin solutions help manufacturers prepare their packaging operations for ePI-linked digital access—without disrupting existing workflows.
Looking Ahead
EMA ePI represents more than a digital leaflet project. It signals a broader shift toward connected, updateable, and patient-centric pharmaceutical information, where physical packaging becomes a gateway to trusted digital content.
For pharmaceutical manufacturers evaluating how their packaging lines can support QR codes, electronic product information, and evolving EU regulatory requirements, Hanin's solutions provide a practical foundation for ePI-ready packaging.
Contact us to learn more about our pharmaceutical coding, marking, and labeling solutions and real-world application cases.
