Skip to main content
Skyniv Atelier

Braille Artwork Execution for Pharma Packaging

Ensuring 100% compliance with EU Directive 2004/27/EC and Marrakesh Treaty standards through validated prepress and embossing grid engineering.

Global Braille Compliance

Explore Global Braille Compliance

In the regulated pharmaceutical industry, accessibility for blind and visually impaired patients is a mandatory compliance requirement across European, North American, and Latin American markets. Incorporating Braille onto outer cartons is not merely a design task—it is a critical safety parameter governed by strict international standards.


At Skyniv Atelier, we bridge the gap between regulatory requirements and print execution, delivering print-ready Braille artwork assets that guarantee legibility, structural integrity, and zero text collisions.

Core Regulatory Standards

EU Directive 2004/27/EC (Article 56a)

  • Mandatory inclusion of the medicinal product name, strength, and pharmaceutical form in Braille on outer packaging.h, and pharmaceutical form in Braille on outer packaging.

  • Precise formatting for multi-strength formulations to prevent dosage errors.

Can-Braille & FDA Guidelines

Customized dot geometry, tactile elevation, and precision spacing engineered specifically for North American distribution networks, strictly adhering to Can-Braille accessibility standards and US FDA packaging guidelines.

Marrakesh Treaty & European Standard (EN 15823)

  • Standardized Marrakesh dot height (minimum 0.12 mm to 0.20 mm) and cell spacing.

  • Adoption of standard Marrakesh medium/large font sizes across European Member States.

Our Technical Prepress Precision

Separate Embossing Layers

Braille is created on a dedicated, non-printing technical layer (Male/Female die specification) isolated from CMYK/PMS print layers.

Knockout & Varnish Zone Alignment

Identification & mentioning of varnish or UV coatings under Braille zones to ensure maximum dot elevation during embossing.

Text Collision Prevention

 Intelligent layout adjustments that prevent Braille dots from obscuring critical legal text, barcodes, or batch/expiry variable data fields.

Character-by-Character Proofreading

Verify to ensure translated Braille dots match the approved text verbatim.