One week ago, Health Canada’s labelling regulations for all non-prescription, off-the-shelf drugs, has changed under the new Plain Language Labelling Regulations (PLL). Health Canada has outlined new rules requiring all drug companies selling off-the-shelf drugs to ensure that the labels are designed with relevant information in a clear table format. The changes are designed to help consumers make correct choices when purchasing and using a product. Health Canada now requires that by June 30, 2021, all labels be PLL compliant.
Like the Nutritional Facts box on food and partially modelled after the Drug Facts box printed on all U.S. non-prescription drugs, Canada's Drug Facts table must have a specific structure without any words touching the lines and some information within the table must be preceded by bullet points.
Key information should be no smaller than 6 points, headings must be in bold with only the first letter capitalized, language must be easy to understand and specific information must be noted.
Luckily, TVT has built-in functionality to help meet Health Canada’s Plain Language Labelling Regulations:
- Font Size: TVT can confirm required font sizes are respected as well as ensuring non- Health Canada compliant fonts are highlighted as deviations.
- Headings: TVT can also identify where certain fonts need to be in bold headings or not capitalized.
- Tables: TVT has special functionality & logic to accurately inspect content inside of tables.
- Bullet Points: TVT can identify misplaced or irregular bullets.
TVT can also be set to ensure corporate style guides are respected. This takes pressure off the graphic team when proofreading.
Finally, TVT can be used to provide assurance that the final document submitted as the mock-up to Health Canada is not only representing all the information that the company had intended to present, but that the document meets the required formatting to be submitted as a mock-up to Health Canada for final approval before production.
While pharmaceutical companies have some time to comply with the new regulations, the guidelines apply immediately for any new off-the-shelf medications production lines.
TVT can make this easy for you: Register for a free TVT inspection with our team and it will be our pleasure to review your old labels to your new PLL compliant labels. We will even provide you with the report to impress your boss!