Health Canada Releases new Industry Guidance for Health Product Labels

Improved labels aim to minimize the risk of confusion and harmful medication mistakes.

Improved labels aim to minimize the risk of confusion and harmful medication mistakes.
Improved labels aim to minimize the risk of confusion and harmful medication mistakes.

Health Canada released new guidance for industry that will help improve the safe use of health products. This will make product labels and packages easier for consumers and health professionals to read and understand.

This guidance is provided in two "Good Label and Package Practices" guides, one for non-prescription (i.e. over-the-counter) drugs and natural health products, and the other for prescription drugs. Together, they will provide industry with direction for designing clear and effective health product labels and packages.

As part of the guidance, instructions are provided for a new standardized Facts Table that will be required on the outer labels of non-prescription drugs, such as cough syrups, pain and fever relievers and allergy remedies.

Using the new Facts Table will make it easier for Canadians to read, understand and use OTC health products safely and to find important product safety information like ingredients, directions and warnings. The table is modeled after the Canadian Nutrition Facts table for foods and a similar table used for non-prescription drugs in the U.S., and is a requirement that will be phased into the Canadian marketplace starting June 2017.

The guides are a part of Health Canada's Plain Language Labelling Initiative, under which important action has been taken to make product labels and packaging information easier to read and understand. This includes introducing the Plain Language Labelling Regulations with new requirements for clear, understandable labels—including the Facts Table for non-prescription drugs—that are being phased into effect. The guides were developed collaboratively by Health Canada and the Institute for Safe Medication Practices (ISMP) Canada, in consultation with stakeholders and an expert panel that included Canadian health professional and patient safety groups along with international regulatory authorities and experts.

“As Minister of Health, I am personally committed to improving the health and safety of Canadians every day. Making labels easier to read and understand helps us all—consumers, patients, families, doctors, nurses and pharmacists—to use health products the way they're meant to be used and avoid dangerous mistakes," Said Jane Philpott, Minister of Health.

“Clear, easy-to-understand labels and packages are essential for using medications safely and avoiding harm. I'm pleased to have worked closely with Health Canada and the members of the expert panel to develop the guides, which I think will go a long way to improving health product labels and packages in Canada,” said David U, President and Chief Executive Officer, Institute for Safe Medication Practices Canada.

More in Pharmaceutical