Health Canada
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About Health Canada

Plain Language Labelling

June 2013

News Release: Harper Government Launches Plain Language Labelling Initiative to Improve Drug Safety for Canadians - Proposed changes will make it easier for Canadians to read drug labels

Drug product labels and packages contain critical information about the safe and effective use of health products and are important tools to help Canadians make informed decisions about their health. To work properly and reduce the chance of harm, drugs should be taken according to the information provided on the label or package.

Yet, drug product information can be confusing to follow. Improvements to drug product labelling and packaging are needed so health professionals, patients and consumers can more easily find out how to use the drug, how often to take it, and when it should not be taken.

What is plain language?

Plain language is a clear writing style that is designed to be easy to read and understand by the intended audience.

The Plain Language Labelling Initiative

The Plain Language Labelling Initiative aims to improve the safe use of drugs by making drug labels and packaging information easier to read and understand. This will be achieved through regulatory and guidance updates and development, as well as through outreach opportunities.

The proposal would advance key safeguards, such as:

  • requiring labels to be in plain language
  • standardizing the format of non-prescription drug labels (such as a "Drug Facts" table) to help users locate important information
  • requiring that companies include contact information on labels so that users can report problems and adverse drug reactions
  • requirements for manufacturers to provide mock-ups of labels and packages for review, and
  • requirements for manufacturers to provide evidence that drug names will not be confused with other authorized products

Timelines

Health Canada plans to roll-out these changes in phases beginning with prescription and then non-prescription drugs. This will be accomplished by updating the regulations, providing guidance and education, and engaging with key stakeholders along the way. This multi-phased project is currently in development with the formal 75-day consultation on the regulatory proposal extending through the summer, followed by analysis of the comments prior to publication in the Canada Gazette, Part II.