Plain Language Labelling Compliance & French Translation

These regulations attempt to improve the safe use of drugs by making drug labels and packaging easier to understand.  The compliance standards impose obligations on health product suppliers to provide information in plain language, so your drug application contains the PLL format label once submitted.  Its goal is to keep language simple and easy to read to reduce the risk to consumers who may face difficulty in reading or interpreting a drug label. 

The PLL Regulations put new obligations on health products manufacturers or sellers with an objective to:

• Give information in plain language
• Submit mock-ups of packages and labels for review
• Assess their health products’ names to avoid confusion
• Provide information in an easy-to-read
• Choose the standardized format to understand easily
• Show how to report harms on the product’s label
• Provide a Canadian Drug Facts Table (CDFT)

PLL Regulations apply to biologic drugs, prescription, and non-prescription pharmaceutical drugs, disinfectants, and radiopharmaceuticals. However, there are some specific requirements that only apply to subsets of these products. For instance, the Canadian Drugs Facts Table (CDFT) requirement is only applicable to non-prescription drugs.

PLL Regulations do not apply to medical devices, veterinary drugs, and drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces or natural health products.

When a DIN application is submitted, a mock label must also be submitted. This mock label must be bilingual (English and French) and contain the correct colour, font size, and type. Labels are provided in an editable format so that Health Canada can make notes on the pdf.