COVID-19 Compliance

Plain Language Labelling Compliance & French Translation

Get assisted by Health Canada experts to make your drug labels and packaging easier to read and understand, thereby meeting requirements of Plain Language Labeling (PLL) compliance and French Translation. We assure your drug application contains the PLL format label when submitted.   

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Plain Language Labelling Compliance

Applied for non-prescription/Over-the-Counter drugs, Plain Language Labeling (PLL) Regulations aim to ensure safe use of drugs.  Its goal is to keep language simple and easy-to-read to reduce 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’ name to avoid confusion;
  • Provide information in an easy-to-read
  • Choose standardized format to understand easily
  • Show how to report harms on product’s label;
  • Provide a Canadian Drug Facts Table (CDFT)

What Products Come within PLL Regulations Range

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, 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.

PLL Regulations Range

How We Help Meet Plain Language Labelling Compliance Regulations

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. Get assistance from Health Canada officials and experienced French Translators. We will help review language labelling, compliance, assure no modification is required to meet regulations and prepare mock-ups of drug package if needs arise.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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