Electronic product information is transforming how pharmaceutical companies manage and deliver regulatory-approved product information in the digital era.
If you want to better understand the concept behind electronic product information, you can explore our article on What is Electronic Product Information? and how it relates to modern e-labelling strategies.
From strategic planning to operational implementation, our experts support the full lifecycle of electronic product information (ePI) — ensuring your product information is structured, accessible and ready for the future of digital healthcare.
One of the most important advantages of electronic product information (ePI) is improved digital accessibility.
Modern e-labelling access enables healthcare professionals and patients to access the most up-to-date medicine information across multiple digital channels, improving both compliance and patient safety. Learn more about e-labelling access and digital channels.
Digital access to up-to-date product information is one of the key goals of the European electronic product information initiative.
Successful electronic product information adoption requires a structured strategy aligned with regulatory expectations. Our experts support companies in planning their e-labelling implementation and developing a clear roadmap for ePI implementation in line with evolving EMA labelling guidelines.
Transitioning to electronic product information requires more than simply converting documents into digital format. Pharmaceutical companies must ensure that product information — including the Summary of Product Characteristics (SmPC), package leaflet and labelling — is structured, compliant and compatible with evolving regulatory systems.
At Billev Pharma East, we help pharmaceutical companies successfully implement and manage electronic product information (ePI) by combining regulatory expertise, digital solutions and lifecycle data management.
We support organisations in defining a clear roadmap for adopting electronic product information, including readiness assessments, governance models and alignment with emerging EU regulatory frameworks.
Our experts guide pharmaceutical companies through the practical implementation of electronic product information, including structured data preparation, document transformation and integration with regulatory systems.
We help organisations establish efficient processes and digital infrastructure for maintaining electronic product information throughout the medicinal product lifecycle, ensuring that updates and regulatory changes are reflected quickly and consistently.
As electronic product information becomes increasingly integrated with digital health platforms and regulatory systems, we support companies in aligning their product information with modern data standards and interoperable formats.
Together with our trusted technology partners, we deliver end-to-end data and document management services that help pharmaceutical companies and healthcare organizations efficiently implement, digitize, and maintain compliant electronic product information (ePI) across the entire product lifecycle.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
Product information is regulated and scientifically validated to aid healthcare professionals in prescribing and dispensing, and to inform patients about the safe use of medicines. The development of electronic product information (ePI) aims to improve access to current product data exactly when it’s needed — whether through mobile, web, or integrated systems.
ePI is official, structured product information for EU medicines, based on the EU Common Standard. Developed by the EMA, national authorities, and the pharmaceutical industry, it ensures regulatory consistency and digital readiness.
Using XML and standard metadata, electronic product information can be integrated into eHealth systems and updated faster than printed leaflets. As part of the EU’s digital shift, e-leaflets and digital PILs offer interactive, mobile-friendly access to the latest approved information—anytime, anywhere.
This transition improves safety, supports adherence, and reduces paper waste.
The EU ePI Common Standard is based on Fast Healthcare Interoperability Resources (FHIR), enabling structured exchange of electronic product information (ePI) across the European medicines regulatory network. This standard ensures that electronic PILs, electronic leaflets, e-leaflets, and e-labeling are compatible with eHealth systems and can be easily accessed by patients and healthcare professionals. By supporting real-time updates and integration with digital platforms, the FHIR-based approach enhances the availability, accuracy, and usability of digital leaflets throughout the medicine lifecycle.
Our representative, Katja Pečjak Reven, was invited as a Subject Matter Expert (SME) to the ePI pilot project team, demonstrating our active role in shaping the future of electronic product information (ePI) in Europe. In collaboration with our partners, we provide end-to-end support for managing electronic PILs, digital leaflets, e-leaflets, and e-labeling—ensuring your pharmaceutical data is accurate, accessible, and aligned with regulatory standards for electronic product information.
February 26–27, 2026 – Amsterdam (The Netherlands):
Billev Pharma East participated in the 24th Regulatory Affairs Conference (RAC26) organised by Medicines for Europe, bringing together regulators and industry experts to discuss the future of pharmaceutical regulation and digitalisation in Europe.
Katja Pečjak Reven, M.Sc. Pharm., Head of Regulatory Affairs at Billev Pharma East, was one of the speakers in Session 2: “How to smoothly transition to modern ways of accessing medicine information by patients?”. The session addressed upcoming changes in EU pharmaceutical legislation affecting Product Information and explored how stakeholders can support the transition to modern, digital access to medicine information. Read more
February 26–27, 2026 – Amsterdam (The Netherlands): At the upcoming 24th Regulatory Affairs Conference (RAC26), Billev Pharma East will spotlight the transformative potential of Electronic Product Information (ePI) as the pharmaceutical industry prepares for new regulatory and digital realities. Katja Pečjak Reven, M.Sc. Pharm. and Head of Regulatory Affairs, is scheduled to present a forward-looking keynote on why ePI will evolve beyond a compliance requirement to become a strategic enabler for digital health and patient access to medicine information. This session will explore how ePI can improve accessibility, interoperability, and regulatory readiness in a landscape increasingly shaped by digitalisation and forthcoming EU legislation changes. Read more
November 11 2025 – Budapest (Hungary): At the recent event in Budapest, Billev Pharma East’s Head of Regulatory Affairs, Katja Pečjak Reven, M.Sc. Pharm., delivered a pivotal keynote titled “Why your company can’t wait: ePI as a catalyst for digital health”, emphasising that electronic Product Information (ePI) is now much more than compliance — it’s a strategic driver of digital transformation.
She outlined a phased roadmap for readiness — governance, tools, data and processes — arguing that organisations which act now will gain competitive advantage by embedding data-centric thinking across regulatory, quality, product and supply-chain functions. Read more
October 21 – 23 2025 – Berlin (Germany): At the Global Pharmaceutical Regulatory Affairs Summit 2025, Billev Pharma East’s Head of Regulatory Affairs, Katja Pečjak Reven, M.Sc. Pharm., delivered two key presentations — “Service Update: Product Management Service” in the “Regulatory Information Management & Digital Transformation” stream, and “Industry Case Study: Experiences with ePI” in the “Global eSubmissions” stream — underlining the company’s commitment to regulatory innovation and digital readiness in the pharmaceutical sector. Read more
September 29 – October 1 2025 – Berlin (Germany): At the TOPRA Symposium 2025, Katja co-led a session titled “Regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard,” emphasising how ePI drives digital transformation and interoperability in the pharmaceutical sector. Read more
May 2025 – Portorož (Slovenia): Katja delivered a presentation on electronic Product Information (ePI) at the 50th SFD Congress, where she explored digital transformation in pharma and the emerging regulatory landscape. She emphasised how ePI supports patient access to up-to-date product information and increases operational agility for manufacturers. Read more
February 2025 – Amsterdam (The Netherlands): Katja delivered a presentation on electronic Product Information (ePI) and its role in the pharmaceutical industry’s digital transformation. She highlighted critical regulatory changes and practical strategies for implementing ePI across the EU. Read more
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