Packaging
Labelling rules by destination, and the mistakes that get containers held
A carton that is right for India is wrong almost everywhere else. Getting this fixed before production costs an email. Getting it fixed after costs a reprint and six weeks.
What each market requires on the pack
| Market | Language | Mandatory on pack |
|---|---|---|
| European Union | Language of each member state where sold | QRD template, MA holder and manufacturer block, MA number, batch and expiry, withdrawal periods for food species, "For animal treatment only" |
| United Kingdom | English | Distribution category (POM-V, POM-VPS, NFA-VPS, AVM-GSL), VM number, MA holder, withdrawal periods |
| Canada | English and French, both | DIN or NN, MA holder, Canadian importer, bilingual directions and cautions |
| Australia & NZ | English | APVMA approval number, restraints, safety directions, first aid, storage and disposal statements |
| GCC & Middle East | Arabic and English | Registration number, local agent block, manufacturing and expiry in Gregorian format, Halal statement where the buyer requires it |
| Africa | English, French or Portuguese by territory | National registration number, local responsible person, batch and expiry, often an import permit reference |
| Southeast Asia | Local language insert plus English pack | Importer block, registration number, storage condition in local units |
| Latin America | Spanish or Portuguese | Registration number, local legal representative, net content in metric |
This is a summary, not a regulatory opinion. Requirements change and a local reviewer should sign off the final artwork. The per-market detail is on the market pages.
Artwork origination
Three routes. Standard manufacturer artwork, which is what most first orders ship on and which suits markets where you are importing under an existing registration. Adapted artwork, where we keep the manufacturer's layout and change language, the responsible person block and the registration number. Full private label, where the pack carries your brand and your design, covered on the private label page.
Adapted artwork takes about two to three weeks from brief to print-ready proof: draft, your review, local regulatory review, colour proof, then print. Charged per SKU at cost, and the charge is credited against the first production order.
Primary packaging options
- Oral liquids in HDPE or amber PET, 30 ml to 5 litres, with tamper-evident caps and a measuring cup or dosing syringe
- Tablets in alu-alu or alu-PVDC blister, or HDPE containers with induction seal and desiccant
- Injectables in Type I or Type II glass vials with bromobutyl stoppers and flip-off seals
- Powders in laminated sachets, HDPE jars or multiwall paper sacks for premix
- Topicals in aluminium tubes, HDPE bottles with trigger sprays, or single-dose spot-on pipettes
Pack format affects shelf life, so changing from alu-alu to PVC blister to save cost can shorten stability. The manufacturer will tell us and we will tell you before you decide.
Serialisation and track and trace
India requires GS1 barcoding on tertiary and secondary packaging for pharmaceutical exports, and we apply it as standard. Some destinations require their own datamatrix or national code on the pack, which is generally the registration holder's obligation rather than the exporter's. If that applies to you, raise it before artwork sign-off.
Five label mistakes that cause customs holds
- Date format. A pack reading 03/09/2027 is ambiguous. Use MMM YYYY or an explicit format on every carton.
- Net content in non-metric units where the market requires metric.
- A missing local responsible person or importer block, which most Gulf and African authorities treat as fatal.
- An HS code on the invoice that does not match the product description on the carton.
- Withdrawal periods omitted on food-producing species products, which is a direct residue-control issue and gets escalated fast.
Common questions
Can you print packs in Arabic, French or Spanish?
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Yes. We work with the manufacturer's artwork studio and a local reviewer in the destination market. Translation is not the hard part. Fitting a bilingual mandatory text block onto an existing carton without dropping required statements is, and it sometimes forces a larger carton.
Who is responsible if a label is wrong?
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Artwork is approved in writing by both sides before printing. If we print something different from what was approved, that is on us and we replace it. If the approved artwork turns out not to satisfy the destination authority, that sits with whoever holds the registration, which is normally you or your agent. Nobody enjoys this conversation, which is why the approval step is formal.
What is the minimum quantity for a custom pack?
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The manufacturer's minimum batch, which for most oral liquids and tablets is in the ten to twenty thousand unit range. Custom artwork on an existing pack size is cheaper than a custom pack size, because the latter may need new tooling or a new carton die.
Do veterinary products need serialisation?
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Not in the same way human medicines do in the EU and US. Some markets are moving toward it, and India requires track and trace barcoding on export cartons for pharmaceuticals, which we apply. Tell us if your market has its own requirement, because it usually sits with the registration holder rather than the exporter.