This document provides information for industry on how Health Canada intends to implement the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) and answers frequently asked questions about plain language labelling. The Regulations are intended to improve the safe use of drugs by making drug labels and packaging easier to read and understand. Key elements of the proposal include requirements to: provide information in plain language; include a look-alike sound-alike assessment of product names to avoid confusion; submit mock-ups of labels and packages for review; indicate how to report harms on product labels; and for some products, to provide information in a drug facts table.
The regulations come into force at two different times: for prescription products and those administered or obtained through a health professional, the new regulations will apply twelve months after registrationin Canada Gazette (CG) Part II. For nonprescription products, the coming into force date is three years after registration in CG Part II. As a result, the information provided below on how the Regulations will be implemented for prescription products and products administered or obtained through health professionals is more detailed; the intention is for this document to provide the basis for consultation on how various guidance documents addressing these types of products will be modified to reflect the new regulations.
This consultation is open for comment until September 2, 2014. Please select and read through the link below titled "consultation document". Sponsors are asked to review the information carefully and to provide their comments on the proposed implementation of the Regulations for prescription products and those products administered or obtained through a health professional, in writing, to the address below before September 2, 2014.
Please note: the implementation of provisions for brand name assessment were the subject of previous consultation and as such, are published here for information only.
For nonprescription products, sponsors are advised that consultation on the implementation of the new regulations will take place at a later date prior to the coming into force of the Regulations in three years.
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Address Locator 3102C5
Holland Cross, Tower B
1600 Scott Street
Interested parties are encouraged to provide comments and suggestions by September 2, 2014.
Health Canada will make the results of this consultation available on this web site.
If you have any questions, contact us at Bureau of Policy, Science and International.