On July 2, 2014, amendments to the Food and Drug Regulations (the Regulations) were issued relating to the labelling and packaging of drug products. In view of the importance of drug labels in providing health professionals, patients and consumers with information relating to the safe and proper use of drugs, the changes are aimed at emphasizing plain language labelling of drugs in Canada. These amendments will apply to human non-prescription and prescription pharmaceutical and biologic drugs for human use.
The amendments include five targeted requirements:
- Plain Language Requirement: The amendments create a general requirement for clear, understandable plain language labels. The format or presentation of labels must also not impede consumer comprehension. Readability of labels can be met by certain elements, such as clear writing, colour contrast, font size and layout of text.
- Contact Information Requirement: The amendments also include a requirement that contact information be placed on labels so that consumers can report medication errors, injury or other events. Consumers must be provided with a clear and transparent mechanism to contact someone responsible for the product in Canada in the event of a reaction or if they have a question or concern.
- Standard Table Format for Non-Prescription Drugs: The amendments include a requirement that outer labels for non-prescription drug include a standard table format to help consumers more readily locate important information. The information in the table is required in both English and French and must include adequate directions for use. The table is intended to assist consumers in locating critical information about a product and in making informed decisions at the point of selection and purchase.
- Submission of Mock-ups of Labels and Packages: The amendments require that a drug submission includes mock-ups of labels and packages displaying an accurate representation of what will be available on the market after the product is approved. Significant changes to label and packaging following product authorization which impact safety will require resubmission of the mock-ups.
- Look-alike/sound-alike [LASA] Name Assessment: Finally, the amendments codify the current Health Canada policy that requires manufacturers to include in their drug submissions evidence that the drug being submitted for approval would not be confused with another drug because of a similar name. For drug names, manufacturers will be need to submit an assessment that the brand name of their drug would not likely be mistaken for the brand, common or proper name of a different authorized drug.
The amendments to the Regulations will come into force in phases in order to provide drug manufacturers with time to implement necessary labelling and packaging changes, and to allow Health Canada properly update its processes and publications. Specifically, a one-year transition period will be granted for prescription drugs and a three-year transition period will be granted for non-prescription drugs.
For more information, the full text of the Regulations amendments can be found here.
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