Package leaflet vs electronic leaflet – understanding the pros and cons for pharmaceutical companies

Every authorised medicine is accompanied by a package leaflet, providing patients with essential information on how to use their medicine safely and effectively. While this approach has supported healthcare for decades, it also creates practical challenges for pharmaceutical companies. Updating printed leaflets across multiple markets is time-consuming, resource-intensive and often requires coordinated changes to artwork, packaging and regulatory documentation. At the same time, healthcare professionals and patients increasingly expect immediate access to the latest approved Product Information through digital channels. This growing demand is also accelerating the adoption of electronic Product Information, which aims to make authorised medicinal product information more accessible, searchable and easier to maintain throughout the product lifecycle.

This growing gap between traditional regulatory processes and modern information needs has accelerated interest in the electronic leaflet. However, many organisations mistakenly view the transition as simply replacing paper with digital documents. In reality, implementing an electronic leaflet requires structured Product Information, robust governance, cross-functional collaboration and well-defined regulatory processes. Without these foundations, companies may struggle with inconsistent content, inefficient lifecycle management and increased compliance risks as digital regulatory initiatives continue to evolve across Europe.

Understanding the pros and cons of a package leaflet and an electronic leaflet is therefore about much more than comparing two document formats. It is about determining how Product Information can remain accurate, accessible and compliant throughout the entire product lifecycle while preparing for the future of electronic Product Information (ePI). In this article, we explore the advantages and limitations of both approaches and explain what pharmaceutical companies should consider before beginning their transition to an electronic leaflet.

What is the difference between a package leaflet and an electronic leaflet?

The main difference between a package leaflet and an electronic leaflet is the way authorised medicinal product information is delivered – not the scientific or regulatory content itself. A package leaflet is the printed document included inside every medicine pack, while an electronic leaflet provides the same approved Product Information in a structured digital format that can be accessed online or through other electronic platforms. Both formats are intended to communicate the safe and effective use of a medicine, but the electronic leaflet is designed to improve accessibility, searchability and lifecycle management without changing the regulatory requirements governing Product Information. The European Medicines Agency (EMA), together with the European Commission and Heads of Medicines Agencies (HMA), has established key principles for electronic Product Information (ePI), confirming that electronic information is intended to complement the traditional paper package leaflet while supporting the digital transformation of healthcare across Europe.

For decades, the package leaflet has been an essential component of every authorised medicinal product. It provides patients with scientifically validated information about indications, dosage, contraindications, warnings, possible adverse reactions and instructions for correct medicine use. Because the package leaflet accompanies every medicine pack, it remains one of the most widely recognised regulatory documents in healthcare. Its content is carefully reviewed during the marketing authorisation process and forms part of the approved Product Information alongside the Summary of Product Characteristics (SmPC) and product labelling. Even as healthcare becomes increasingly digital, the package leaflet continues to play a critical role in ensuring that patients receive reliable information at the point of dispensing.

An electronic leaflet, however, expands the possibilities of how Product Information can be managed and accessed throughout the product lifecycle. Rather than existing as a static PDF or printed insert, electronic Product Information is created using a common structured standard that enables information to be searched, reused and shared across multiple digital systems. This structured approach allows healthcare professionals and patients to access the latest authorised information more easily while creating opportunities for integration with electronic health records, prescribing systems and other digital health initiatives. Unlike printed package leaflets, which may remain in circulation until existing stock has been distributed, an electronic leaflet can reflect newly approved regulatory updates much more rapidly, ensuring that users have access to the most current Product Information.

Importantly, pharmaceutical companies should not view the package leaflet and the electronic leaflet as competing alternatives. Current European initiatives do not aim to eliminate the paper package leaflet but to create a harmonised framework in which both formats can coexist while serving different user needs. As regulatory expectations continue to evolve, organisations that understand the strengths of both the package leaflet and the electronic leaflet will be better positioned to build efficient Product Information processes that support compliance today and future digital transformation tomorrow.

Why are many pharmaceutical companies struggling with the transition from a package leaflet to an electronic leaflet?

For many pharmaceutical companies, the biggest challenge is not deciding whether to use a package leaflet or an electronic leaflet – it is managing the complex regulatory and operational processes that sit behind both. While the package leaflet has traditionally been created as a document for printing and inclusion in medicine packs, the electronic leaflet requires organisations to think very differently about Product Information. Instead of managing static documents, companies must manage structured, reusable and continuously maintained regulatory content throughout the entire product lifecycle. Organisations that continue to rely on fragmented document-based processes often discover that their existing workflows are not prepared for this shift, making the transition more complex than initially expected.

One of the most common problems is that Product Information is frequently managed across multiple departments using disconnected systems and inconsistent processes. Regulatory Affairs may own the approved text, Medical Writing may prepare updates, Pharmacovigilance may trigger safety variations, while translation vendors, artwork teams and local affiliates all maintain their own versions of the same information. Although this approach has supported the production of a printed package leaflet for many years, it becomes increasingly inefficient when organisations need to deliver accurate, structured electronic leaflet content across multiple markets. Every variation, safety update or wording change can require significant manual effort, increasing the risk of inconsistencies, duplicated work and unnecessary delays. At the same time, healthcare professionals and patients increasingly expect immediate access to the latest authorised Product Information, placing additional pressure on existing regulatory processes. EMA has identified many of these limitations as key drivers behind the development of electronic Product Information, highlighting the need for better accessibility, interoperability and more efficient lifecycle management.

Another challenge is that many organisations mistakenly approach the electronic leaflet as a technology project rather than a business transformation initiative. Purchasing new software alone does not solve problems related to governance, content ownership or data quality. If Product Information is not standardised before digital implementation begins, companies often transfer existing inefficiencies into new systems instead of eliminating them. Successful implementation therefore starts with understanding how Product Information is created, reviewed, approved, translated and maintained across the organisation. Only after these processes have been optimised can technology deliver the efficiency gains that electronic Product Information is designed to support. Pharmaceutical companies that address these organisational challenges early are significantly better positioned to manage both today’s package leaflet requirements and tomorrow’s electronic leaflet environment with greater consistency, compliance and operational efficiency.

For many pharmaceutical companies, these challenges remain hidden until the first large-scale Product Information update, safety variation or digital implementation project begins. At that point, fragmented processes that were manageable for a traditional package leaflet often become major obstacles to delivering accurate and compliant electronic leaflet content across multiple markets.

Why electronic leaflets are changing Product Information management – not just document formats

The transition from a package leaflet to an electronic leaflet is often described as a move from paper to digital. In reality, it represents a much broader transformation in how pharmaceutical companies manage Product Information throughout the entire lifecycle of a medicinal product. While the content of a package leaflet remains subject to the same regulatory requirements, the introduction of electronic Product Information (ePI) requires organisations to move away from document-based processes and towards structured, reusable and interconnected data. Rather than managing individual Word files, PDFs or locally maintained documents, companies must establish Product Information that can be created once, maintained consistently and distributed across multiple regulatory and digital channels. This shift reflects the broader objectives of the European ePI initiative, which aims to improve accessibility, interoperability and the efficient maintenance of authorised Product Information across the European Union.

For many organisations, this change exposes long-standing inefficiencies that have developed over years of managing the package leaflet through disconnected processes. Product Information is frequently created, reviewed and updated by multiple functions, including Regulatory Affairs, Medical Writing, Pharmacovigilance, Translation, Artwork and Quality. When each department relies on separate documents, systems or local versions, maintaining consistency becomes increasingly difficult as the number of products and markets grows. Implementing an electronic leaflet does not eliminate these challenges on its own. Instead, it requires organisations to establish clear Product Information governance, define ownership of regulatory content and ensure that approved information remains accurate throughout every regulatory procedure and lifecycle update. Without these foundations, companies risk transferring inefficient document management practices into new digital platforms rather than achieving meaningful operational improvements.

The organisations that will gain the greatest value from the electronic leaflet are those that recognise it as an opportunity to modernise Product Information management rather than simply digitise existing documents. By adopting structured content, harmonised workflows and robust governance models, pharmaceutical companies can reduce duplication, improve collaboration across functions and respond more efficiently to regulatory changes. This approach not only supports future electronic leaflet requirements but also strengthens lifecycle management for today’s package leaflet, creating a more scalable and sustainable foundation for regulatory compliance as digital transformation continues across the European medicines regulatory network.

This evolution also reflects the broader transformation of drug labeling, where structured Product Information is becoming increasingly important for efficient lifecycle management.

Why should pharmaceutical companies prepare for electronic leaflets now instead of waiting for regulatory deadlines?

Waiting until electronic leaflet requirements become mandatory may appear to reduce short-term costs, but in reality it often increases implementation complexity and operational risk. Although the traditional package leaflet will continue to play an important role under the current legislative framework, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission are steadily progressing with the implementation of electronic Product Information (ePI). The initiative is supported by a common technical standard, a phased implementation roadmap and practical guidance for marketing authorisation holders, demonstrating that the transition towards structured Product Information is already underway rather than being a distant regulatory concept.

Preparing early gives pharmaceutical companies the opportunity to improve far more than their future electronic leaflet capabilities. As ePI requirements continue to evolve across the European medicines regulatory network, organisations that establish structured Product Information, robust governance and harmonised workflows today will be better positioned to adapt to future regulatory expectations with minimal disruption.

It allows organisations to review how Product Information is created, approved, translated and maintained throughout the entire product lifecycle. Many companies discover that their existing processes rely on multiple disconnected systems, duplicated content and manual document management. These inefficiencies may be manageable when producing a printed package leaflet, but they become increasingly difficult to sustain as structured electronic Product Information requires consistent data, harmonised workflows and reusable content. Organisations that address these challenges before implementation can improve regulatory efficiency, reduce the effort required for lifecycle updates and establish stronger governance across Regulatory Affairs, Medical Writing, Pharmacovigilance and related functions. Rather than reacting to future regulatory obligations, they create processes that are scalable and resilient as digital requirements continue to evolve.

Early preparation also reduces implementation risk. Introducing new technology without first standardising Product Information often results in organisations transferring fragmented processes into a modern digital platform, limiting the value of the investment. By contrast, companies that first establish governance, improve data quality and define ownership of Product Information are better positioned to adopt the EU ePI Common Standard and future digital regulatory initiatives with minimal disruption. As EMA continues to expand guidance, publish implementation resources and develop the ePI roadmap, organisations that invest in readiness today will be able to transition from a traditional package leaflet to an electronic leaflet more efficiently while maintaining regulatory compliance and ensuring patients and healthcare professionals always have access to accurate, up-to-date medicinal product information.

As European regulators continue expanding electronic Product Information initiatives, organisations that postpone preparation may eventually need to redesign Product Information processes under significantly greater time pressure.

What does a successful transition from a package leaflet to an electronic leaflet look like?

A successful transition from a package leaflet to an electronic leaflet is rarely the result of implementing new technology alone. Organisations that achieve the greatest long-term benefits typically begin by strengthening the regulatory and operational foundations that support Product Information management. Rather than treating the electronic leaflet as a standalone deliverable, they establish a structured approach to creating, reviewing, approving and maintaining Product Information across the entire product lifecycle. This enables them to respond more efficiently to safety updates, regulatory variations and changes affecting multiple markets while maintaining consistency across all authorised product information. As the European Medicines Agency continues to advance the implementation of electronic Product Information (ePI), companies with well-governed Product Information processes will be better positioned to adopt the EU ePI Common Standard with minimal disruption.

Successful organisations do not digitise documents, they redesign Product Information processes.

Successful organisations also recognise that the transition affects far more than Regulatory Affairs. Medical Writing, Pharmacovigilance, Quality, Translation, Artwork and Information Technology all contribute to the accuracy and maintenance of Product Information. Without clearly defined governance, responsibilities and standardised workflows, even the most advanced digital platforms cannot eliminate duplicated effort or inconsistent content. By contrast, organisations that harmonise their Product Information processes before implementation are able to improve collaboration, reduce manual activities and establish a single source of truth for both the package leaflet and the future electronic leaflet. This approach supports not only regulatory compliance but also greater operational efficiency throughout the product lifecycle.

Ultimately, a successful transition should not be measured by how quickly a company publishes an electronic leaflet, but by how effectively it manages Product Information after implementation. The organisations that gain the greatest value are those that build sustainable governance, structured content and scalable lifecycle management processes from the outset. This aligns closely with the objectives of the European ePI initiative, which aims to improve accessibility, interoperability and the efficient maintenance of authorised Product Information while complementing the existing paper package leaflet.

Why Billev Pharma East is the right partner for your transition from a package leaflet to an electronic leaflet

Every pharmaceutical company begins its transition from a package leaflet to an electronic leaflet from a different starting point. Some organisations already have mature Product Information governance, while others still rely on fragmented processes developed over many years. As an independent ePI service provider, Billev Pharma East helps pharmaceutical companies prepare for the transition to electronic Product Information by combining Regulatory Affairs, Medical Writing and digital regulatory expertise into a single, integrated service. Rather than focusing solely on technology implementation, we help organisations establish the governance, structured content and Product Information processes required for long-term regulatory success.

Our consultants work closely with pharmaceutical companies to assess organisational readiness, establish Product Information governance, optimise review and approval workflows, prepare structured content and develop practical implementation strategies aligned with evolving European ePI requirements. This integrated approach helps organisations reduce compliance risks while creating sustainable Product Information processes that support both current package leaflet obligations and future electronic leaflet implementation.

Our expertise extends beyond implementation planning. We support organisations throughout the entire Product Information lifecycle, from defining governance and preparing structured content to managing regulatory updates and long-term lifecycle maintenance. Clients also benefit from our direct involvement in the European ePI initiative through Katja Pečjak Reven, who has served as an Industry Subject Matter Expert within the EMA/HMA electronic Product Information initiative since 2022. This provides practical insight into how electronic leaflet requirements are evolving across Europe and how organisations can prepare before implementation becomes routine across the EU regulatory network. As the European rollout of ePI progresses through a phased implementation supported by EMA and national competent authorities, companies that establish robust Product Information processes today will be significantly better positioned for tomorrow’s regulatory landscape.

Our support extends beyond implementation projects. We help organisations establish sustainable Product Information governance that improves collaboration between Regulatory Affairs, Medical Writing, Pharmacovigilance, Translation and Quality teams. This enables companies not only to prepare for electronic leaflet implementation but also to improve the efficiency and consistency of Product Information management throughout the entire lifecycle of every medicinal product.

Preparing for the future of package leaflets and electronic leaflets

The discussion surrounding the package leaflet and the electronic leaflet is no longer simply about paper versus digital information. It reflects a broader transformation in how pharmaceutical companies create, govern and maintain Product Information throughout the product lifecycle. Organisations that begin strengthening their Product Information processes today will not only be better prepared for future electronic Product Information requirements but will also improve regulatory efficiency, data quality and lifecycle management across their entire portfolio. In an increasingly digital regulatory environment, preparation is no longer a competitive advantage—it is becoming a business necessity. Organisations that invest in Product Information management today will be better positioned to adapt to future electronic Product Information initiatives while improving regulatory efficiency, data quality and patient access to trusted medicinal product information.

Frequently asked questions

Can an electronic leaflet replace a package leaflet?

At present, an electronic leaflet is intended to complement rather than fully replace the traditional package leaflet. While electronic Product Information (ePI) is being introduced across Europe, the printed package leaflet remains an important regulatory requirement in many markets.

Why is the electronic leaflet becoming important in Europe?

The electronic leaflet supports better access to up-to-date Product Information, improves searchability and enables more efficient lifecycle management. It is a key component of the European electronic Product Information (ePI) initiative, which aims to modernise how medicinal product information is managed and shared.

When should pharmaceutical companies prepare for electronic leaflets?

Pharmaceutical companies should prepare for electronic leaflets as early as possible. Early preparation allows organisations to optimise package leaflet processes, improve Product Information governance and establish structured content before future ePI requirements become more widely implemented.

What is electronic Product Information (ePI)?

Electronic Product Information (ePI) is a structured digital format for authorised medicinal product information, including the Summary of Product Characteristics (SmPC), package leaflet and labelling. It enables Product Information to be more accessible, searchable, interoperable and easier to maintain throughout the product lifecycle.

Sources: 1 – European Medicines Agency (EMA). (2020). Electronic product information for human medicines in the European Union – Key principles, 2 – European Medicines Agency (EMA). (2020). Key principles for the use of electronic product information for EU medicines, 3 – European Medicines Agency (EMA). (2020). Electronic product information for human medicines in the European Union – Key principles (PDF), 4 – European Medicines Agency (EMA). (2026). ePI Frequently Asked Questions (FAQs), 5 – European Medicines Regulatory Network (EMRN). (2025). Electronic Product Information (ePI) Implementation Guide, 6 – European Medicines Agency (EMA). (2026). ePI Guidance documents and training material.