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 French.
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 labels.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
