We specialize in developing Electronic Product Information (ePI) to ensure healthcare professionals and patients have timely access to regulated, scientifically validated information about medicines. Our solutions support the transition from traditional paper leaflets to electronic PILs (Patient Information Leaflets), also known as electronic leaflets, e-leaflets, or e-labeling, ensuring up-to-date, accessible, and user-friendly content.
With digital leaflets becoming a cornerstone of modern healthcare communication, the adoption of ePI represents a significant step toward improving patient engagement, reducing errors, and promoting sustainability. Whether presented as a digital leaflet on a mobile device or integrated into clinical decision support tools, electronic product information helps bridge the gap between regulatory data and real-world use.
Together with our partners, we can provide a comprehensive set of services related to data and document management, supporting pharmaceutical companies and healthcare organizations in digitizing and maintaining electronic product information.
Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202
1000 Ljubljana
Slovenia
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
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.
With a focus on expert guidance and strategic insights, we propel your projects forward with confidence, ensuring every step is handled with precision.
Regulatory Affairs
Pharmacovigilance
Medical Consultancy
Quality/GxP
Digital Consultancy
