Electronic Product Information (ePI)—often referred to in common parlance as a “digital package insert”—is changing the way professional information, package inserts, and labeling will be provided in the future. For pharmaceutical companies, this is not just a technical issue: The ongoing reform of EU pharmaceutical legislation is introducing new standards, deadlines, and requirements regarding comprehensibility, for which marketing authorization holders should begin preparing now.
What is Electronic Product Information (ePI)?
The ePI consolidates the legally required drug information—the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labeling—into a structured, electronic format. Unlike a simple PDF, it is designed to be machine-readable and can be searched, filtered, and integrated into other digital systems, such as electronic health records or e-prescription applications.
Access is generally intended to be provided via a 2D barcode on the package, which links to a version of the information that is always up to date—on a central EU portal, a company website, or, in the future, directly within health insurance apps. Important to note: The ePI does not currently replace the paper insert, but rather supplements it.
What are the legal frameworks and standards at the EU level?
The regulatory framework for ePI has evolved over several years:
• 2018 – Guideline on Mobile Technologies (EMA/493897/2015 Rev. 1): For the first time, this guideline permits the use of QR codes, NFC, and 2D barcodes for centrally authorized medicinal products, with mandatory multilingual information for all countries where the product is marketed (updated in 2026 with Rev. 2).
• January 2020 – “Key Principles” from the EMA and HMA (EMA/766923/2019): seven principles for the ePI, including harmonization, interoperability, technology neutrality, patient safety, and multilingualism.
• February 2022 – Release of the EU ePI Common Standard: a structured data format based on FHIR (Fast Healthcare Interoperability Resources), whose specification is publicly available on GitHub. A follow-up project under the EU4Health initiative is testing its practical implementation.
The key legal lever is the major reform of EU pharmaceutical legislation: the proposed directive to replace Directive 2001/83/EC and the new regulation to replace Regulation (EC) No. 726/2004. The current final compromise text of the new directive (ST 6367/26) provides for the gradual digitization of product information. In principle, both electronic and printed package inserts are to be provided. However, Member States may stipulate that package inserts be made available exclusively in electronic form. In this case, a paper version must continue to be provided to patients free of charge upon request.
The Council and the European Parliament reached a political agreement on the reform on December 11, 2025; the final compromise texts were published in March 2026. Formal adoption has not yet taken place. As things stand, the new legal acts are scheduled to enter into force in 2026, followed by a transition period at the end of which—expected to be in 2028—the new regulations will apply throughout the EU. Companies should keep an eye on this timeline, as details may still change before the final publication in the Official Journal.
What is the current situation in Germany, and what pilot projects are already underway?
At the European level, Germany generally supports the further development of EU pharmaceutical legislation. The German legal framework will need to be specifically adapted to the new European requirements once they have been finally adopted and have entered into force.
It remains to be seen how Germany will implement the new EU requirements at the national level. The current compromise text gives member states some flexibility: Germany could continue to require a paper version as part of every medication package, or switch to electronic package inserts as the standard, in which case patients would still be entitled to a free paper version upon request.
Pilot Projects to Date: The EMA has already successfully tested ePI in an initial phase (2023–2024) in collaboration with national authorities (including Denmark, the Netherlands, Sweden, and Spain) to evaluate the creation and lifecycle management of ePI within the central EU portal. In addition, there are various national initiatives across Europe (such as approaches to “Patient Information 4.0” in Germany or hospital pilot projects).
Current User Acceptance Tests (UAT): The EMA conducts structured user acceptance tests to specifically evaluate the practical application and usability of the Product Lifecycle Management (PLM) portal.
What unresolved issues are currently shaping the political debate?
Two discussions are currently shaping the future of the ePI:
• “Key Information Section”: In 2025, the EMA conducted a public consultation on a potential standardized “Key Information Section” in the package insert. The goal of such a section would be to make particularly important safety warnings and information on a drug’s benefit-risk profile easier to find. Industry associations such as Pharma Deutschland oppose this—in their view, the digital navigability of the ePI renders a separate summary unnecessary and instead creates additional regulatory burdens without any clear safety benefit.
• Digital divide: Organizations such as the ABDA (Federal Union of German Pharmacists' Associations) and the VdK social welfare association warn that older patients or those who are not very tech-savvy must not be disadvantaged, and call for printed package inserts to remain available indefinitely.
Added to this is accessibility: As of June 28, 2025, the European Accessibility Act (Directive 2019/882) will be mandatory in the EU. Among other things, it requires text-to-speech functions, zoom options, and multilingual content. Regardless of this, accessibility is a key goal of ePI development. These requirements directly affect the approximately 30 million people with visual impairments in the EU and must be taken into account from the very beginning when designing digital product information.
What does ePI mean for readability tests and user testing?
One key point is easily overlooked in the debate on digitization: The requirement for clear and understandable design is not waived simply because the information is in electronic form. According to Article 64(3) of the new proposal for legislative amendments (ST 6367/26), package inserts must continue to reflect the results of consultations with target patient groups (readability user tests) to ensure that they are easy to read, understandable, and user-friendly—regardless of whether the information is read on paper or on a screen.
Digital formats present their own challenges that traditional readability tests have not yet addressed:
• Navigation and user experience (UX) across various devices—from smartphones to tablets used in medical practices.
• "Layering"—that is, organizing information into chapters and subsections—must remain intuitive to navigate.
• Compatibility with screen readers and other assistive technologies.
• Clarity of icons, pictograms, and search functions—not just the body text.
Those who develop digital product information should therefore incorporate digital user testing into the established readability testing methodology early on, rather than adding it as an afterthought shortly before submission.
Where can I get help preparing for electronic product information?
Beate Beime Pharma Consulting supports pharmaceutical companies in the preparation and implementation of electronic product information (ePI)—from the analysis of existing product information through its structured formatting to implementation and quality assurance. In doing so, we combine our many years of experience in regulatory affairs, product information, and readability user testing with the evolving requirements for the electronic provision of drug information.
We assist you with:
• Analysis and evaluation of existing product information
• ePI Readiness and Gap Analysis
• Structuring and formatting product information
• ePI Conversion and Implementation
• Review of content and data structures
• Quality Control and Regulatory Review
• Integration of ePI and patient-centered information
In addition, we conduct readability tests of package inserts using the interview method validated and standardized by Dr. Beate Beime—including for digital product information. You can find more information about our services on our “Electronic Product Information (ePI)” and “Readability User Test” pages.
Sources
• European Medicines Agency ( medicinal product, EMA): Reform of EU pharmaceutical legislation
• Directive 2001/83/EC, as well as the proposed replacement directive COM(2023) 192 and regulation COM(2023) 193
• EMA/HMA: Key Principles for Electronic Product Information (EMA/766923/2019)
• EU ePI Common Standard (FHIR Specification, as of February 2022)
• Section 11 of the German Medicines Act (AMG)
• BPI, Pharma Deutschland, Pro Generika, vfa: Information on the “diGItal” pilot project
• Directive (EU) 2019/882 – European Accessibility Act