The transition to electronic Product Information (ePI) is often viewed as a regulatory requirement driven by the evolving European pharmaceutical legislation. While compliance is undoubtedly a key objective, ePI has impact far beyond meeting regulatory obligations. It changes how medicinal product information is governed, maintained, distributed, and accessed throughout its lifecycle.
Unlike traditional paper leaflets, ePI introduces the opportunity to provide up-to-date information through digital channels, making it easier for patients, healthcare professionals and other stakeholders to access. As a result, organisations should consider not only the regulatory approval and lifecycle of product information, but also how ePI can be easily accessed and consumed by patients and healthcare professionals in an increasingly digital healthcare society.
This broader perspective highlights the importance of governance, interoperability, multilingual access, information dissemination, and patient-centered experience, emerging initiatives and technologies:
demonstrate that the success of ePI comes from combining strong regulatory compliance with the ability to deliver authoritative information efficiently and reliable to patients.
Organisations that embrace ePI as more than a compliance exercise can unlock real opportunities to improve information accessibility, patient engagement, and operational efficiency. Realising the full value of ePI requires a holistic approach that considers both the creation and the dissemination of medicines information across the European healthcare ecosystem.
National medicines compendia, such as Rote Liste Service GmbH in Germany or medicines.ie in Ireland, already play an important role in the European medicines-information ecosystem. Where they have an established presence across a number of European Member States, they provide established, trusted and widely used access points for authorised medicinal product information. Their role is not limited to the passive publication of package leaflets or summaries of product characteristics. Rather, they play a critical role in improving health literacy for patients in their country, acting as practical dissemination channels that make regulated information findable, usable and accessible in national healthcare contexts.
The value of compendia is based on three complementary capabilities.
In the context of European ePI, compendia should therefore be seen as part of the broader dissemination and access layer. EMA and national competent authorities will define regulatory standards, validation requirements and official infrastructure, but successful ePI implementation also requires user-facing channels that work in national languages, national healthcare settings and real-life usage scenarios. Compendia are trusted to help bridge this gap by combining authorised product information with established publication processes, local healthcare knowledge and user-oriented digital services.
This role becomes particularly important as Europe moves toward a more interoperable ePI environment. Structured ePI creates the technical foundation for consistent exchange and reuse, but it does not automatically solve questions of discovery, localisation, usability or integration into daily healthcare practice. National compendia can contribute to this implementation layer by making authorised information accessible through trusted, familiar and nationally embedded channels. In this sense, they are a complementary access and dissemination infrastructure that can help translate ePI from a regulatory standard into practical value for patients, healthcare professionals and marketing authorisation holders.
The Alliance for Medicines Information (AMI) is a European alliance of established national medicines compendia from Denmark (Medicin.dk), Ireland (medicines.ie), Finland (Pharmaca Fennica), Norway (Felleskatalogen), Germany (Rote Liste), and Sweden (Fass). It was created to explore a practical, scalable path toward trusted, regulator-approved electronic medicines information and a pan-European approach to electronic Product Information (ePI). AMI builds on existing national infrastructures, established relationships with regulators and industry, and decades of experience in providing quality-controlled medicines information to patients, healthcare professionals and pharmaceutical companies. Across the six participating countries, the founding compendia collectively provide access to approximately 30,000 digital package leaflets, integrated into healthcare systems and routinely used by millions of patients and healthcare professionals across Europe, demonstrating that ePI implementation in Europe does not need to start from a blank slate. Instead, AMI proposes to reuse proven national systems and connect them through an interoperable AMI Hub and portal, enabling users to retrieve validated, up-to-date medicines information from trusted national sources across borders.
In the European ePI landscape, AMI’s role is particularly relevant because it addresses one of the central implementation risks: fragmentation. Without a coordinated approach, Europe could face multiple national platforms, divergent technical interfaces, duplicated processes for marketing authorisation holders, and inconsistent access routes for patients and healthcare professionals. AMI therefore aims to provide a harmonised, multilingual and interoperable pathway for the dissemination of validated ePI, aligned with European standards while still respecting national regulatory frameworks and local healthcare contexts. Importantly, AMI is positioned not as a replacement for the future EMA repository, but as a practical implementation layer that can complement European infrastructure by connecting established national compendia, supporting national adaptations and enabling user-friendly access in real-world settings.
For pharmaceutical companies and trade associations, AMI offers the prospect of a single, coordinated channel for distributing regulator-approved ePI across multiple European markets. This could reduce operational workload, manual rework, duplicated submissions and compliance complexity, while supporting real-time access to validated, structured information. For regulators, AMI can contribute practical implementation experience, governance models and technical learnings from countries where digital medicines information is already embedded in healthcare systems. For patients and healthcare professionals, the added value lies in reliable access to official, current and understandable medicines information, including multilingual content, accessibility features and enriched services such as product images, instructional videos or other national support materials where available. In this way, AMI can help strengthen health literacy, support safe medicine use and counter misinformation by ensuring that authoritative scientific information remains easy to find, easy to trust and easy to use.
Start your ePI journey with our latest blog post Introduction of ePI - The Future of Medicines Information, or discover our dedicated cormeo ePI resource hub, bringing together everything you need to know about electronic Product Information in one place.