Introduction
The European Accessibility Act (EAA) — Directive (EU) 2019/882 — applies across the EU from 28 June 2025. It harmonises accessibility requirements for a wide set of products and services in the internal market, driving a step-change in how organisations plan, design, and verify accessibility. AccessibleEU confirms the 28 June 2025 application date and multiple legal analyses underline the same timeline.
Medicines already have a distinct rule: the name of the product must appear in Braille on the outer packaging under Directive 2004/27/EC (amending Directive 2001/83/EC, Article 56a).
Key Development
The EAA introduces cross-sector accessibility obligations—spanning digital interfaces, e-commerce, self-service terminals and more.
Even though medicinal packaging is not an EAA-listed product category, the Act’s systems view of accessibility will influence regulated industries: purchasers, quality teams, and notified bodies will increasingly expect integrated accessibility evidence rather than isolated, checklist-style fixes.
For pharmaceutical manufacturers, this means moving from compliance-only Braille labelling towards a holistic accessibility mindset—where tactile, visual and digital design considerations are planned together from the outset.
Technical and Regulatory Impact
For pharmaceutical packaging, the baseline remains unchanged: EU law mandates Braille on outer packaging, and ISO 17351:2013 defines the technical method — including the Marburg Medium spacing, dot-height tolerances, and legibility verification.
Complementary guidance from the European Commission and EMA on labelling readability continues to apply.
What changes with the EAA is the expectation of lifecycle integration:
- Inclusive information design: Maintain clear print hierarchy and contrast while ensuring Braille placement does not compromise sighted readability — consistent with ISO 17351 principles.
- Process integration: Build accessibility into design inputs, supplier controls, validation (including Braille dot height and reader testing), and change control.
- Physical–digital continuity: Link printed packs with accessible electronic product information (ePI), ensuring equivalent usability across media.
The convergence of ISO 17351 and EAA principles strengthens the expectation that accessibility data be traceable and verifiable throughout the supply chain.
Actionable Implications
- Update internal standards – Embed EAA principles into packaging SOPs and style guides alongside ISO 17351 and EU labelling rules. Reference Marburg Medium spacing and national Braille codes explicitly. For artwork creation, use PharmaBraille fonts and procedures to ensure correct sizing and spacing.
- Strengthen supplier requirements – Require converters to demonstrate compliance for Braille dot height, spacing, and legibility verification, and to document accessibility controls within their quality systems.
- Tighten documentation – Include explicit accessibility acceptance criteria in artwork approvals, Design History Files, and Supplier Quality Agreements. Record the rationale for Braille layout and readability outcomes.
- User engagement – When measurement verification is constrained, conduct legibility tests with qualified Braille readers as described in ISO 17351 Annex A.2.
- Digital parity – Align electronic product information and online materials with accessible design patterns (headings, logical order, ARIA attributes where relevant).
- Country-specific implementation – The EU rule for Braille on outer packs continues to apply; verify national guidance (e.g. Fimea, FAMHP) for local expectations and templates.
References
- Directive (EU) 2019/882 (European Accessibility Act): AccessibleEU overview
- Directive 2004/27/EC amending Directive 2001/83/EC (Article 56a — Braille): EUR-Lex
- ISO 17351:2013 — Packaging — Braille on packaging for medicinal products
- EC Guideline on the readability of labelling and package leaflets of medicinal products
- EMA Product Information Requirements and Templates
- National guidance: Fimea (Finland) | FAMHP (Belgium)
Leave a Reply