July 27, 2015
Health Canada will be enforcing the new Plain Language Labeling regulations beginning June 13, 2015 as part of the government initiative to improve drug safety by having product labels easier to understand. A guidance document has been released to assist the industry and health care professionals with compliance.
The regulation covers prescription drugs, such as biologics and radiopharmaceuticals. Compliance for non-prescription drug label compliance is required beginning June 13, 2017.
The following is required:
- Submission of information in plain language
- Assessment of the health products’ name to avoid confusion
- Submission of mock-ups of labels and packages for review
- Indication of how to report harms on their product’s label
- Submission of information in an easy-to-read format
The labeling requirements include:
- The labeling information that is required by these Regulations shall be:
- Prominently displayed
- Readily discernible to the purchaser or consumer under the customary conditions of purchase and use
- Expressed in plain language, both in English and French
- The format of the label, including the displayed text and graphics, shall not hinder the comprehension of the required information by these Regulations
- Adequate directions for use of the drug
- Quantitative list of the drug's medicinal ingredients by their proper names or, if they have no proper names, by their common names
- The drug's non-medicinal ingredients listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients
- Contact Information
The regulations do not apply to:
- Existing products since these rules do not apply retroactively but existing products are expected to eventually conform
- Other healthcare products such as medical devices, veterinary medicines or natural health products, which will retain current labeling requirements