Do Canadian drug labels have to be bilingual, and where do translation errors creep in?

Partly. Canada's Food and Drug Regulations (section A.01.015) require label statements to be in English or French, in addition to any other language. Directions for use have to be in both English and French when a drug is sold without a prescription from an open self-selection area. Our view: where both versions are required, each one has to be right.

This page is general information, not legal or regulatory advice.

What the Canadian rule says

• Required label statements must be in either English or French, plus any other language on the label.
• Directions for use must be in both English and French if the drug is sold without a prescription in an open self-selection area.

This differs from the US rule, where every required statement must appear in every language the label uses. See bilingual and translated drug labels in the US.

Where translation adds wrong words

Our view, as practice advice rather than a rule:

• A correct translation of a wrong source word passes every translation check, because the translator rendered what was there.
• Machine translation can pick a real word with the wrong sense. It's spelled right in the target language, so spellcheck says nothing.
• Back-translation shows whether the target says what the source says. It doesn't show whether the source was right.
• Two versions can drift after one is edited and the other isn't.

What helps

Check the source for meaning before it goes to translation. Have a fluent reviewer read each language's directions and warnings for meaning, and compare the two versions line by line after every change. See how to proofread label sections for meaning.

Sources

• Justice Laws Website: Food and Drug Regulations (C.R.C., c. 870)
• eCFR: 21 CFR 201.15

Last reviewed: October 14, 2026

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Do Canadian drug labels have to be in English and French?

Required label statements must be in English or French. Directions for use must be in both when the drug is sold without a prescription in an open self-selection area.

Can a correct translation still contain a wrong word?

Yes. If the source has a wrong word, an accurate translation carries it into the other language.

Does back-translation catch wrong words?

It shows whether the translation matches the source. It doesn't show whether the source itself was right.