The pharmaceutical industry is entering one of the most significant changes in product information management in decades. While the traditional package leaflet remains a regulatory requirement, companies are now preparing for the gradual introduction of the electronic leaflet through the European Medicines Agency’s electronic product information (ePI) initiative. This transition is now anchored in the revised EU pharmaceutical legislation: the European Parliament and Council reached a provisional political agreement on the reform package in December 2025, which is expected to be formally adopted later in 2026. Rather than replacing the paper leaflet overnight, ePI introduces a structured digital layer that will fundamentally change how product information is created, maintained, submitted, and distributed throughout the product lifecycle.

For many pharmaceutical companies, however, the challenge extends far beyond understanding the differences between an electronic leaflet and a package leaflet. Existing regulatory processes were designed around Word documents, PDFs, manual reviews, and country-specific workflows. Transitioning to ePI introduces new requirements for structured data, governance, cross-functional collaboration, and digital infrastructure. Without careful planning, organisations risk selecting unsuitable technologies, redesigning inefficient processes, increasing regulatory complexity, and placing additional pressure on already resource-constrained Regulatory Affairs teams.

Understanding the ePI vs traditional package insert pros and cons is therefore no longer simply an academic exercise. It is becoming a strategic business decision that will influence regulatory efficiency, operational costs, submission quality, and long-term lifecycle management. Companies that begin preparing early can establish a clear implementation roadmap, avoid costly rework, and transition to ePI in a controlled and compliant manner. Those that delay may face compressed implementation timelines, limited external support, and greater operational disruption as regulatory expectations continue to evolve.

What is an electronic leaflet?

An electronic leaflet is a structured, machine-readable version of authorised medicinal product information that complements the traditional package leaflet. As part of the European Medicines Agency’s electronic product information (ePI) initiative, it enables product information—including the Summary of Product Characteristics (SmPC), package leaflet, and labelling—to be created, maintained, and exchanged in a standardised digital format based on the HL7 FHIR data model.

Unlike a PDF or Word document, an electronic leaflet is designed to be interoperable with healthcare systems, pharmacy software, accessibility technologies, and future digital health services. This allows authorised product information to be updated more efficiently while improving accessibility for healthcare professionals, patients, and regulatory authorities.

Importantly, the electronic leaflet does not immediately replace the traditional package leaflet. During the transition to ePI, pharmaceutical companies will need to maintain both formats while preparing their internal systems, governance, and regulatory processes for structured electronic product information.

What pharmaceutical companies need to do before implementing an electronic leaflet

Preparing for an electronic leaflet involves far more than converting an existing package leaflet into a digital format. The transition to electronic product information (ePI) requires pharmaceutical companies to rethink how product information is created, governed, maintained, and submitted throughout the entire product lifecycle. Because ePI is based on the EU ePI Common Standard and the HL7 FHIR data model, organisations must establish processes that support structured, machine-readable product information while continuing to maintain traditional regulatory documents during the transition period.

The first step is to assess organisational readiness. Companies should evaluate their existing product information portfolio, regulatory processes, submission volumes, language requirements, and internal capabilities to identify potential implementation gaps. This assessment should also determine whether current systems, governance models, and operating procedures can support structured authoring, data management, future ePI submissions, and evolving ePI requirements. At the same time, organisations should define a clear implementation roadmap, establish cross-functional governance involving Regulatory Affairs, Medical Affairs, Quality, IT, and translation teams, and assign clear ownership for ePI activities. These elements are consistently highlighted as critical success factors for successful implementation.

Equally important is selecting the right long-term implementation strategy. Rather than focusing solely on software, companies should carefully evaluate how future workflows, structured authoring, quality control, data validation, translation processes, and lifecycle management will operate together. Teams responsible for maintaining the package leaflet and electronic leaflet should also receive appropriate training to understand structured product information, FHIR principles, and the operational changes introduced by ePI. Organisations that invest in readiness, governance, and process redesign early will be significantly better positioned to implement ePI efficiently, minimise regulatory risk, and support future regulatory requirements with confidence.

How Billev Pharma East helps companies successfully transition to an electronic leaflet

Successfully implementing an electronic leaflet requires much more than technical expertise. Choosing the right ePI service provider means selecting a partner who understands European regulatory expectations, the operational realities of pharmaceutical companies, and the strategic decisions that determine whether an ePI project succeeds or becomes a costly long-term challenge. At Billev Pharma East, we help pharmaceutical companies navigate every stage of the transition from a traditional package leaflet to structured electronic product information with confidence, clarity, and regulatory certainty.

Unlike software vendors, we take a vendor-neutral approach focused on finding the solution that best aligns with your portfolio, regulatory obligations, internal processes, and long-term business objectives. Every engagement begins with a comprehensive ePI readiness assessment, during which we evaluate your existing product information processes, organisational readiness, governance, submission complexity, multilingual requirements, and internal capabilities. Based on these findings, we develop a practical implementation roadmap that supports informed investment decisions, minimises implementation risks, and helps organisations avoid costly vendor lock-in. This methodology is reflected in our three-phase approach: Readiness Diagnostic, Selection & Implementation Support, and Execution.

Our support extends far beyond strategy. We help organisations redesign regulatory workflows, establish governance models, evaluate software vendors, prepare structured product information, oversee content migration, perform quality control, support testing, and guide implementation from initial planning through long-term lifecycle management. Most importantly, our clients benefit from the expertise of Katja Pečjak Reven, an ePI subject matter expert who has served as an Industry Subject Matter Expert within the EMA/HMA ePI initiative since 2022. This gives our clients access to practical insight into how ePI is evolving across Europe—not just how the guidance is written, but how it is being implemented in real regulatory practice. When pharmaceutical companies partner with Billev Pharma East, they gain more than an implementation provider—they gain an experienced strategic advisor committed to making their transition to an electronic leaflet efficient, compliant, and future-ready.

Electronic leaflet vs package leaflet: pros and cons

When evaluating the ePI vs traditional package insert pros and cons, it is important to recognise that both the electronic leaflet and the traditional package leaflet serve the same regulatory purpose: providing approved medicinal product information. The difference lies in how this information is created, maintained, distributed, and used throughout the product lifecycle.

The traditional package leaflet has served patients and healthcare professionals for decades and remains an essential regulatory document. However, maintaining multiple language versions, implementing frequent safety updates, and managing numerous national variations often creates significant operational complexity for pharmaceutical companies.

By comparison, an electronic leaflet introduces structured product information that can be integrated with digital healthcare systems, updated more efficiently, and reused across multiple regulatory and operational processes. Industry position papers from the Inter-Association Task Force (IATF) — representing AESGP, EFPIA and Medicines for Europe — highlight additional advantages, including a reduced environmental footprint from lower paper and ink use and greater supply chain agility, since electronic product information makes it easier to reallocate multi-country packs to markets facing shortages. At the same time, successful implementation requires investment in governance, structured authoring, workflow redesign, and organisational readiness.

Advantages of an electronic leaflet

Compared with a traditional package leaflet, an electronic leaflet offers several advantages for pharmaceutical companies. Structured product information supports greater consistency across markets, improves lifecycle management, facilitates multilingual updates, and enables integration with digital healthcare systems. Industry position papers also point to concrete patient-facing benefits, including the ability to adjust font size, the use of video and interactive content, search functionality, and even personalised information for specific patient groups. It allows authorised product information to be reused across multiple regulatory processes and provides a stronger foundation for future digital health initiatives. Beyond the patient experience, moving away from paper is also expected to support environmental sustainability and help mitigate medicine shortages, by making it easier to move multi-country packs to where they are needed. As ePI adoption progresses, these capabilities are expected to improve operational efficiency while supporting more effective management of medicinal product information.

Challenges of an electronic leaflet

Despite its advantages, implementing an electronic leaflet requires significant organisational preparation. Pharmaceutical companies must redesign regulatory workflows, establish governance for structured product information, train cross-functional teams, and ensure that existing systems can support the creation, maintenance, and submission of ePI. Companies must also plan for patients who are not yet ready to rely solely on digital information: under the revised EU legislation, patients retain the right to request a free printed copy of the package leaflet where it is only made available electronically, and industry position papers explore practical ways to meet this obligation, such as printing at the point of dispensing, self-service kiosks in pharmacies and health centres, or community printing hubs. Organisations should also recognise that implementing an electronic leaflet is fundamentally a change management programme rather than simply a software implementation project. Companies that prepare early — including for the practicalities of serving patients with limited digital access — are better positioned to minimise implementation risks and achieve a smoother transition from the traditional package leaflet.

Benefits of an electronic leaflet for pharmaceutical companies

For pharmaceutical companies, adopting an electronic leaflet offers benefits that extend well beyond regulatory compliance. Structured product information improves consistency across markets, simplifies lifecycle management, supports multilingual content updates, and reduces reliance on document-based processes.

An electronic leaflet also enables closer integration with regulatory information management systems, translation workflows, and future digital healthcare platforms. As regulatory requirements continue to evolve, companies with mature ePI capabilities will be better positioned to manage product information efficiently while improving data quality, operational scalability, and regulatory compliance.

Beyond regulatory compliance, an electronic leaflet can improve collaboration between Regulatory Affairs, Medical Affairs, Quality, and translation teams by enabling structured product information to be managed more consistently across multiple markets. It also supports future digital healthcare initiatives and creates a stronger foundation for long-term regulatory lifecycle management.

Challenges of implementing an electronic leaflet

Although the long-term benefits are considerable, implementing an electronic leaflet presents several organisational challenges. Most pharmaceutical companies must redesign established regulatory workflows, introduce structured authoring processes, train multidisciplinary teams, and establish governance models capable of supporting structured product information throughout the product lifecycle.

Another common challenge is selecting the appropriate implementation approach. Technology alone is rarely sufficient. Organisations must ensure that software, regulatory processes, quality management, translation workflows, and lifecycle governance operate as a single integrated system. Companies that begin planning early are significantly more likely to avoid costly implementation delays and unnecessary operational disruption.

ePI vs traditional package insert: what pharmaceutical companies should consider before making the transition

There is no universal answer to whether an electronic leaflet is “better” than a traditional package leaflet. While the benefits of ePI are significant, successful implementation depends on how well an organisation prepares for the transition. The most successful projects are not driven by technology alone—they begin with a clear understanding of regulatory requirements, organisational readiness, business objectives, and long-term lifecycle management. Companies that treat ePI as a strategic transformation rather than a simple digital conversion are far more likely to achieve efficient and compliant implementation.

One of the most important considerations is that ePI does not simply replace existing product information. During the transition period, pharmaceutical companies will need to maintain both the traditional package leaflet and the electronic leaflet, ensuring consistency across all authorised product information while introducing structured, machine-readable content based on the EU ePI Common Standard and HL7 FHIR. This requires robust governance, well-defined processes, cross-functional collaboration, and reliable quality control. Organisations should also evaluate whether their current regulatory systems, document management practices, translation workflows, and variation management processes are capable of supporting this new operating model.

Industry experience gathered through the IATF also points to a practical sequencing question many companies underestimate: products administered by healthcare professionals (in hospitals, clinics, or specialist care settings) are generally further along in this transition than products patients take home and self-administer. Pilot projects already running in markets such as Belgium, Luxembourg, Spain and the Baltics have tested removing the paper leaflet for HCP-administered products first, on the basis that healthcare professionals can access and interpret ePI directly. Companies with mixed portfolios should factor this distinction into their readiness assessment and roadmap, since HCP-administered products may reach electronic-only product information sooner than self-administered ones, and the pace of any transition will also depend on decisions taken at Member State level under the new legislation.

Equally important is the selection of the right implementation strategy. Rather than focusing solely on software capabilities, companies should assess long-term scalability, integration with existing regulatory processes, internal resource availability, training needs, and future lifecycle management. Early planning allows organisations to establish realistic budgets, redesign workflows before implementation begins, and avoid rushed decisions as ePI adoption accelerates across Europe. Ultimately, when evaluating the ePI vs traditional package insert pros and cons, the greatest determinant of success is not the technology itself, but the quality of preparation before implementation starts.

Why pharmaceutical companies should prepare for ePI now

Although mandatory ePI implementation will be introduced gradually, delaying preparation can significantly increase both costs and implementation risks. As more pharmaceutical companies begin their ePI programmes, demand for specialised expertise, implementation resources, and technology providers is expected to grow rapidly.

The pace of change is already picking up. The revised EU pharmaceutical legislation reached political agreement in December 2025 and is moving through the final steps of formal adoption in 2026. In March 2026, EMA and the EU medicines regulatory network published a draft roadmap for a coordinated ePI rollout, with vaccines expected to go live on a voluntary basis in the third quarter of 2026, followed by oncology products in the fourth quarter of 2026. Early preparation allows organisations to assess their readiness, establish realistic budgets, redesign internal workflows, and make informed implementation decisions before regulatory timelines become more demanding. Companies that start planning today will be better positioned to transition from the traditional package leaflet to the electronic leaflet in a structured, efficient, and compliant manner.

Preparing for the future of electronic product information

The transition from a traditional package leaflet to an electronic leaflet is not simply a regulatory milestone—it represents a fundamental transformation in how pharmaceutical companies create, manage, and maintain product information throughout the entire product lifecycle. Organisations that begin preparing today will be better positioned to meet future regulatory expectations, streamline regulatory operations, and reduce implementation risks as ePI adoption continues across Europe.

At Billev Pharma East, we help pharmaceutical companies turn this complex transition into a structured, practical, and compliant implementation programme. From ePI readiness assessments and implementation roadmaps to vendor-neutral advisory, workflow redesign, content migration, quality control, and long-term lifecycle support, our team provides end-to-end expertise tailored to your organisation. If you are evaluating the ePI vs traditional package insert pros and cons or preparing your first electronic leaflet project, our specialists are ready to help you build a future-ready ePI strategy with confidence.

Whether you are evaluating the advantages of an electronic leaflet, comparing the ePI vs traditional package insert pros and cons, or planning a portfolio-wide implementation programme, Billev Pharma East provides the regulatory expertise and practical support needed to ensure a successful transition. From readiness assessments and implementation planning to structured content migration and long-term lifecycle management, we help pharmaceutical companies build sustainable ePI capabilities with confidence. Contact Billev Pharma East to discuss your ePI readiness and develop an implementation strategy that supports both today’s regulatory requirements and tomorrow’s digital product information landscape.

Frequently asked questions

Sources: 1 – European Medicines Agency. (2026). Electronic product information (ePI), 2 – European Medicines Agency, Heads of Medicines Agencies, & European Commission. (2020). Electronic product information for human medicines in the European Union – key principles, 3 – European Medicines Regulatory Network. (2025). Electronic Product Information (ePI) Implementation Guide, 4 – Product Lifecycle Management (PLM) Portal. (2024). FHIR Implementation Guide for ePI – Now live, 5 – European Medicines Regulatory Network. (2025). EU ePI Common Standard – FHIR Implementation Guide, 6 – European Medicines Agency. (2024). Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines, 7 – Inter-Association Task Force (AESGP, EFPIA & Medicines for Europe). Position paper on phasing in of electronic product information and phasing out of the paper package leaflet, 8 – Inter-Association Task Force (AESGP, EFPIA & Medicines for Europe). Alternative ways of providing the printed package leaflet of medicinal products, 9 – European Parliament. (2025-2026). Revision of the EU pharmaceutical legislation – Legislative Train Schedule and background note on the provisional agreement (11 December 2025), 10 – European Medicines Agency. (2026). Electronic product information (ePI) roadmap (draft, March 2026).