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Drugs and Health Products

Consultation on the Plain Language Labelling Initiative

Health Canada recognizes that labels are critical for communicating information about health products.  The purpose of the Plain Language Labelling Initiative is to make improvements to ensure health product labels are clear, accurate, easily understandable, and minimize opportunities for confusion with labels, packages or names.  There are two types of improvements being suggested:  proposed amendments to the existing Food and Drug Regulations that govern drug product labelling and proposed modifications to processes at Health Canada.  The proposed regulatory amendments are posted in Canada Gazette, Part I, and are explained in documents below. Information is provided for drug manufacturers to understand what they will need to do in order to comply with the proposed regulatory amendments for mock-ups of labels and for a Fact Table, while the document for Canadians provides information about the proposed regulatory and process changes under this initiative.  All of these changes will lead to differences in labelling materials.

How to get involved

This consultation is open for comment until September 6, 2013. Please read through the information provided and select the appropriate links below.

Information for Canadians

Details about what Canadians can expect to see from the changes proposed under the Plain Language Labelling Initiative are available on the Health Canada website.

Draft regulations

The proposed amendments to the Food and Drug Regulations will require health product labels to be more clear, accurate and easier to understand. On June 22, 2013, Health Canada published in Canada Gazette, Part I, a regulatory proposal to amend the Food and Drug Regulations.

To access and comment, please Next link will take you to another Web site visit the draft regulations.

Information about future guidance documents

The proposed regulatory amendments under the Plain Language Labelling Initiative will be supported by the creation of new documents for some provisions and by revisions to guidance documents for industry. Information on how Health Canada plans to implement the proposed requirement for a Fact Table and the requirement to submit mock-ups are available below.

To access and comment, please go to:

For more information

To comment on the individual consultation elements, click on the above links.

For general questions and concerns, please contact:

policy_bureau_enquiries@hc-sc.gc.ca

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C5
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

Interested parties are encouraged to provide comments and suggestions by September 6th, 2013.