The adoption of the Directive on the Union code relating to medicinal products for human use (2026) marks the most significant overhaul of EU pharmaceutical legislation in over two decades. Replacing Directive 2001/83/EC, the new framework introduces a modernised approach to product information — with digital leaflets (electronic Product Information, ePI) at its core.
This article focuses on the implications of Sections 127–130, Article 63(3) and following provisions (pp. 231–234), and Article 74 (p. 247) of the Council compromise text, with particular attention to how they reshape the future of patient information.
1. A Regulatory Shift Toward Digital Product Information
The new Directive formalises the transition from traditional paper leaflets to digital-first product information systems. While earlier legislation assumed the presence of a printed leaflet inside every medicinal package, the revised framework introduces structured, electronic, and potentially paperless delivery models.
This reflects a broader EU objective: ensuring that medicinal product information is:
- Continuously updatable
- Accessible across Member States
- Machine-readable and interoperable
- Adaptable to patient needs (including accessibility requirements)
Digital leaflets (ePI) are therefore no longer an experimental concept — they are becoming a regulatory standard.
2. Sections 127–130: Core Provisions on Digital Leaflets
Sections 127 to 130 introduce key principles governing how package leaflets may be provided in the future.
2.1 Digital as a Primary Format
The Directive establishes that product information, including the package leaflet, may be made available in electronic format. This enables:
- Centralised updates without reprinting
- Real-time safety communication
- Reduced environmental and logistical burden
2.2 Accessibility and Patient-Centric Design
A critical requirement is that digital leaflets must remain:
- Easily accessible
- Understandable
- Available to all users, including vulnerable populations
This aligns with EU obligations on accessibility and non-discrimination.
2.3 Member State Flexibility
The Directive allows Member States to determine how digital leaflets are implemented, including:
- Whether paper leaflets remain mandatory
- Whether digital-only models are permitted
- How access is ensured (e.g. QR codes, national portals)
This flexibility creates heterogeneity in implementation, at least in the short term.
2.4 Safeguards for Public Health
Despite the shift to digital, the Directive maintains that patient safety and access to information remain paramount, requiring safeguards where digital access may be limited.
3. Article 63(3) and Beyond: From Paper Default to Conditional Paper
Article 63 represents one of the most consequential changes.
3.1 Removal of Mandatory Paper Leaflets
The new provisions allow Member States to replace paper leaflets with electronic versions, marking a departure from decades of regulatory practice.
3.2 Conditional Access to Paper
Where digital leaflets are used, the framework introduces the principle that:
- Patients must still be able to obtain a paper leaflet upon request
- This must be provided free of charge and without undue delay
This creates a hybrid model, where digital becomes the default but paper remains a safety net.
3.3 Continuity with Existing Logic
The evolution builds on earlier regulatory mechanisms that allowed exceptions to leaflet requirements under specific conditions, but expands this from an exception-based approach to a system-level design.
4. Multilingual Requirements and Digital Opportunities (Article 74)
One of the most important — and often underestimated — dimensions of medicinal product information in Europe is multilingual accessibility. Article 74 reinforces this requirement while enabling a more efficient digital approach.
4.1 Continued Obligation for Multilingual Leaflets
The Directive maintains the principle that product information must be available in the official language(s) of the Member State where the medicinal product is marketed.
This ensures that:
- Patients receive information in a language they understand
- Communication remains locally relevant and compliant
- National authorities retain control over linguistic requirements
4.2 From Static Translations to Dynamic Content
Digital leaflets fundamentally change how multilingual content is managed:
- Translations can be centrally updated and synchronised
- Safety changes can be reflected simultaneously across all languages
- Version inconsistencies are significantly reduced
This replaces the traditional model of static, printed translations.
4.3 Smarter Language Delivery
Digital formats enable more advanced and user-friendly multilingual solutions:
- User-selected language interfaces
- Geo-localised content delivery
- Accessibility features, including simplified text or assistive tools
This marks a shift toward user-centric communication, rather than purely compliance-driven translation.
4.4 Reducing Packaging Constraints
Multilingual paper leaflets have historically resulted in dense, multi-language documents folded into small packages.
With digital leaflets:
- Users access only the language they need
- Packaging complexity is reduced
- Readability improves significantly
4.5 Harmonisation with Flexibility
While language requirements remain national, digitalisation enables:
- A single structured source of content (ePI)
- Multiple controlled language outputs
- Greater consistency across Member States
At the same time, national authorities continue to define accepted languages and oversee translation quality.
5. Learning from eIFU: How Paper Leaflets Can Still Be Provided
The transition to digital leaflets closely mirrors the approach already taken with electronic Instructions for Use (eIFU) in the medical device sector.
5.1 The eIFU Model
Under the eIFU framework:
- Instructions may be provided digitally (e.g. via QR code or website)
- A paper version must be available on request
- Clear instructions must explain how to access or request it
5.2 Applying the Same Model to Medicinal Products
A similar approach can be applied to medicinal leaflets:
On-pack communication
- QR code or URL linking to the digital leaflet
- Clear statement indicating paper availability
Multi-channel access
- National or EU web portals
- Pharmacy-assisted access
- Support services (e.g. call centres)
On-demand paper fulfilment
- Provided via pharmacies or delivery services
- Free of charge to the patient
5.3 Benefits of the Hybrid Approach
This model ensures:
- Inclusivity and accessibility
- Regulatory compliance
- Operational efficiency
Paper becomes a targeted, on-demand service, rather than a universal default.
6. Expected Timeline for Implementation
While the Directive has reached a final compromise stage (2026), implementation will occur progressively.
6.1 Legislative Adoption (2026)
Formal adoption and publication in the Official Journal.
6.2 Transposition Period (≈ 18–36 months)
Member States will transpose the Directive into national law and define their approach to digital leaflets.
6.3 Gradual Rollout (2027–2029)
Deployment of electronic product information (ePI) systems, aligned with EMA and HMA initiatives.
6.4 Full Maturity (Post-2029)
Digital leaflets become the default model across most Member States, with paper available on request.
7. What This Means for Stakeholders
For Marketing Authorisation Holders (MAHs)
- Prepare for structured digital content (ePI)
- Implement hybrid delivery models
For Regulators
- Define national frameworks and safeguards
- Ensure equitable access
For Patients
- Benefit from up-to-date, accessible information
- Retain the right to paper versions when needed
Conclusion
The 2026 Directive marks a paradigm shift in how medicinal product information is delivered in Europe. Sections 127–130, Article 63, and Article 74 collectively establish a digital-first, multilingual, and patient-centric framework.
Digital leaflets will improve accessibility, accuracy, and efficiency — while multilingual capabilities ensure that no patient is left behind. At the same time, the continued availability of paper on request reflects a balanced and inclusive transition.
The future of leaflets is clearly digital — but, as demonstrated by the eIFU model, paper is not disappearing; it is evolving into a responsive, on-demand service.
For more insights on digital leaflets and ePI implementation, follow updates on the eLeaflet blog.