- Registration Date 2016-07-04
- Hit 605
Health Canada released new guidance today 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 over-the-counter health products safely and to find important product safety information like ingredients, directions and warnings. The table is modelled 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.
Division
Written by Risk Information Division