Pharmaceutical Folding Cartons: Braille, Tamper Evidence and Space for Serialisation
Quick answer
For medicines sold in the EU, the name of the medicinal product must generally appear in Braille on the outer packaging (Directive 2001/83/EC, Article 56a). Most prescription medicines also need an anti-tampering device and a unique identifier printed as a 2D DataMatrix. Plan all three on the dieline at the same time: Braille away from folds, glue flaps and the code area; a tamper feature that shows when the pack has been opened; and an unvarnished zone for inline coding. Confirm the exact requirements for each product with your regulatory team.
Quick facts: Custom Pharmaceutical Packaging
- Indicative unit price: about US$0.05–0.10 per piece. This is a guide, not a quotation: the final price depends on size, material, print colours, finish and order quantity.
- MOQ: typically from 500 pcs per size and artwork; the confirmed minimum depends on material, print method and features and is stated on the quotation.
- Lead time: Physical samples 5–7 working days after artwork is confirmed; bulk production 20–30 days after sample approval.
- Who makes it: BestPackFactory’s own factory in Longhua District, Shenzhen, China. Free dieline and artwork proof within 24 hours. See real samples and videos.
- Specifications and quote: Custom Pharmaceutical Packaging · Request a quote
Carton layout checklist
| Element | Typical requirement or practice | What to check on the dieline |
|---|---|---|
| Braille | Product name in Braille on the outer pack (EU); strength often added | Panel, position, distance from creases and glue flap |
| Tamper verification | Anti-tampering device on most prescription medicines (EU) | Type of feature, which flap it sits on, opening direction |
| Unique identifier | 2D DataMatrix plus human-readable data, printed per pack | Size and position of the coding window, free of varnish |
| Batch and expiry | Printed or embossed per batch | Space that does not overlap Braille or the code |
| Leaflet and contents | Patient leaflet folded inside | Inside dimensions allow for leaflet thickness |
This guide covers layout planning. It is not regulatory advice; requirements differ by market and product, and your regulatory affairs team should confirm them.
Braille: what the EU requires and how it is produced
Article 56a of Directive 2001/83/EC (added by Directive 2004/27/EC) requires that the name of the medicinal product, as defined in Article 54(a), be expressed in Braille format on the packaging, and that the package leaflet be made available in formats suitable for blind and partially sighted people on request from patients' organisations. Some products, for example those intended to be administered only by healthcare professionals, may be treated differently under guidance; check this with your regulatory team rather than assuming an exemption.
In practice, Braille on cartons is embossed by the cutting and creasing tool or by a separate embossing step, using raised dots formed in the board. Points to plan:
- Text: confirm the exact Braille text for each market. Article 54(a) refers to the name followed by strength and pharmaceutical form, and national authorities and Commission guidance explain how much of this must appear in Braille, so get the approved text from your regulatory team.
- Dot height and spacing: EN ISO 17351 (Braille on packaging for medicinal products) is the usual reference. It recommends the Marburg Medium spacing convention unless a national rule says otherwise and sets a target dot height of about 0.2 mm, with limits on how many measured dots may fall below lower thresholds. Agree the target and the measuring method with the supplier.
- Position: keep Braille on a flat panel, clear of creases, the glue flap and the tamper feature. A line of Braille that crosses a fold is hard to read.
- Reverse side: embossing raises the board on the inside too; check that it does not interfere with the product, leaflet or cartoning machine.
- Print overlap: Braille can be embossed over printed areas, but avoid placing it over small text or the barcode, where the dots would make printed information hard to read.
- Verification: ask for a Braille check on the sample, against the approved Braille text, and keep the record with your artwork approval.
Tamper evidence: choose a feature that fits the line
In the EU, Delegated Regulation (EU) 2016/161 under the Falsified Medicines Directive requires safety features, including an anti-tampering device, on most prescription medicines. EN ISO 21976 describes tamper verification features for medicinal product packaging and is commonly used as a reference; it also expects the feature not to compromise the readability of statutory information, including tactile markings such as Braille. Common carton-based options include:
| Feature | How it works | Points to confirm |
|---|---|---|
| Glued tuck flap with perforated tear-off | The carton must be torn along a perforation to open | Glue position, tear strength, how the pack looks after opening |
| Tamper-evident label or seal | A label across the opening breaks, tears or shows a pattern when removed | Label application on the packing line, label size and position |
| Tear strip or zip opening | A cut strip that cannot be closed again once pulled | Opening direction, effect on carton strength |
Choose a carton-integrated feature when your cartoning machine can glue the closing flap; choose a label or seal when you need to add tamper evidence without changing the carton or line. Test the opened pack: a pharmacist or patient should see at once that it has been opened.
Space for serialisation
The unique identifier is normally printed on the packing line, so the carton must provide a clear coding window: unvarnished or with a varnish that accepts the ink, sized for the DataMatrix and the human-readable product code, serial number, batch and expiry, and placed where the line's printer and camera can reach it. Keep Braille, the tamper feature and creases out of this window. Code content, symbol size and verification are covered in the pharma carton GS1 DataMatrix checklist, so they are not repeated here.
What to send in your RFQ
- Carton dimensions, style (for example tuck end or glued bottom) and the product it holds, with the leaflet.
- Approved Braille text per market and the dot specification you require.
- Tamper feature type and which flap it is on; cartoning machine details.
- Coding window size and position, and your coding equipment.
- Artwork files, board grade preference and finish (noting the unvarnished zone).
- Quantity per SKU and market, and the documents your quality team needs.
BestPackFactory quotes pharmaceutical folding cartons and other custom pharmaceutical packaging as B2B projects with MOQ 500 PCS. Braille embossing method, tamper feature options and documentation are confirmed in the quotation.
Common mistakes
- Placing Braille across a crease or on the glue flap.
- Embossing Braille over the coding window or small mandatory text.
- Adding tamper evidence after the dieline is approved, forcing a new tool.
- Varnishing the whole carton, leaving no surface the coding ink can key to.
- Approving Braille without checking it against the approved text on a physical sample.
- Stacking cartons under heavy pressure in transit, which can flatten Braille dots.
Frequently asked questions
Is Braille required on medicine cartons in the EU?
Under Article 56a of Directive 2001/83/EC, the name of the medicinal product must be expressed in Braille on the packaging. Some products may be treated differently under guidance, so confirm with your regulatory team.
Where should Braille be placed on a folding carton?
On a flat panel, clear of creases, the glue flap, the tamper feature and the coding window, and not over small printed text or barcodes.
What tamper-evident options work on folding cartons?
Common options are glued flaps with perforated tear-offs, tear strips and tamper-evident labels or seals. Choose based on your cartoning line and test the opened pack.
Why must the coding window be free of varnish?
The serialisation code is usually printed on the packing line, and many varnishes stop the ink from bonding or drying properly. Leave an unvarnished zone or use a varnish confirmed for your coding ink.
Related pages
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Send your carton dimensions, Braille text, tamper feature, coding window and quantity per SKU. Projects are quoted as B2B orders with MOQ 500 PCS. You can also reach Lisa on WhatsApp +86 158 8653 0985 or at lisa@colorprintingpackage.com.
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