How confident are you that your French labelling is compliant?
While the Food and Drug Regulations require drug labels to
display most of the information in both official languages (i.e.
English and French), draft labels for drugs and natural health
product (NHPs) only have to be submitted for approval by Health
Canada in either English or
Even if the version submitted to Health Canada is compliant,
that does not mean that the final and bilingual text is. Keep in
mind that consumers will likely only read one of the two versions
– English or French – regardless of which version was
approved. Consumers expect the information in both versions to have
the same meaning.
What happens if there are discrepancies between the information
in the two languages in the final bilingual text, such as
translation errors or omissions? An error or omission (e.g. missing
warning, recommended use not consistent with the product license or
erroneous directions of use), although present in only one of the
two versions, could represent a significant risk to health and
safety and attract enforcement action by Health Canada.
As labelling errors can become a serious compliance issue,
manufacturers, importers and distributors of drugs and NHPs must
ensure that labels display the same approved information in both
official languages. To that end, it is recommended that companies
seek assistance from professional translators with sufficient
experience in this area instead of relying on online translation or
translation software, and ensure that there are sufficient checks
in place to confirm regulatory compliance of bilingual
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