The label and package are the first points of interaction between a health product and a consumer. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This sometimes made it difficult for the consumer to easily identify information necessary for appropriate selection and proper use of the product. In some cases, the information appeared in small type, with poor contrast between the label text and the background. All of these factors can prevent the consumer from finding the information needed to make informed purchasing decisions in a timely manner.
As part of Health Canada’s PLL initiative, the outer label of non-prescription drugs is required by regulations to display a Canadian Drug Facts Table (CDFT) to place information required by the regulations in a standardized, easy-to-read format and in a consistent location on the label in order to enhance the safe and effective use of non-prescription drugs. The concept is similar to that of the Nutrition Facts Table for foods in Canada and the Drug Facts box required by the Food and Drug Administration for over-the-counter (OTC) drugs in the United States.
What are the Plain Language Labelling (PLL) Regulations?
The PLL Regulations impose new obligations on health products sponsors to:
- Provide information in plain language;
- Assess the name of their health products to avoid confusion;
- Submit mock-ups of labels and packages for review;
- Indicate how to report harm(s) on their product’s label;
- Provide information in an easy-to-read and standardized format, and;
- Provide a Canadian Drug Facts Table (CDFT).
What products are within the scope of the PLL Regulations?
The PLL Regulations apply to prescription and non-prescription pharmaceutical drugs, biologic drugs, radiopharmaceuticals and disinfectants. However, there are specific requirements that only apply to subsets of these products. For example, the Canadian Drug Facts Table requirement only applies to non-prescription drugs. These PLL Regulations do not apply to medical devices, veterinary drugs, drugs that are represented as being solely for use as a disinfectant on hard non-porous surfaces, or natural health products.
When do the PLL Regulations come into force for non-prescription drugs?
For non-prescription products, the PLL Regulations came into force on June 13, 2017. New PLL requirements will be applied to submissions received on or after the coming into-force date.
By June 30, 2021, all non-prescription drug products must be in full compliance with the PLL Regulatory requirements at the retail level.
What is the purpose of submitting label mock-ups?
The Plain Language Labelling Regulations obliges sponsors to provide Health Canada with full color 2-dimensional mock-ups of labels and packages that represents the information consumers and health professionals will see at the time of filing an application for a drug identification number. These mock-ups will be reviewed by Health Canada to ensure labels comply with existing regulatory requirements on labelling. The review will focus on (but is not limited to) comprehension, legibility, accuracy and valid application of the CDFT, and design elements such as font size, type, colour, and placement.
What flexibilities are available for the Canadian Drug Facts Table (CDFT)?
All products under the scope of the PLL Regulations must provide a CDFT. However, some products and package sizes may not present sufficient space to accommodate the CDFT in the standard format on the label. In some cases, an innovative label may be the most effective way to accommodate the space requirements of the CDFT. In other cases, a modified format with graduated flexibilities may be considered according to the criteria outlined in Table 3 of the Guidance Document: Labelling Requirements for Non-prescription Drugs.
If you want to be sure your product labels and packages are in compliance with Canadian Plain Language Labelling requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.
References
Guidance document: Labelling Requirements for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling-requirements-non-prescription-drugs.html
Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs, 2018-09-28, Health Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-questions-answers-plain-language-labelling-regulations-non-prescription-drugs-contact-lens-disinfectants.html