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Cannabis Regulations Published in the Canada Gazette, Part II

July 25, 2018

The Cannabis Act received Royal Assent on June 21, 2018. The Cannabis Regulations, which outline the rules for the legal production, distribution, and sale of cannabis, were published on July 11 2018, in Canada Gazette II.

Guidance on the regulatory framework for health products containing cannabis or for use with cannabis that are approved under the Food and Drugs Act (FDA) is now available online at https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-cannabis-act-food-and-drugs-act-related-regulations.html. This guidance document provides information on requirements for licensed activities, rules that apply to the health products themselves, and obligations for certain healthcare professionals.

The documents incorporated by reference in the Cannabis Regulations, such as: the Consumer Information – Cannabis, the Cannabis Health Warning Messages, and the Standardized Cannabis Symbol have been posted online at: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/regulations-support-cannabis-act.html

In addition, certain guidance documents, such as Guidance for health products containing cannabis or use with cannabis, have been posted online at: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/cannabis-licensing-guide.html.  

This is another important step in the process of legalizing and strictly regulating cannabis in Canada. 

For questions related to submissions and applications for health products containing cannabis or for use with cannabis, natural health products containing permitted parts of the cannabis plant, or clinical trial requirements, please contact the cannabis single-window at the Health Products and Food Branch of Health Canada: hc.hpfb_cannabis_dgpsa.sc@canada.ca.

Please note that the single-window does not address veterinary products. Inquiries related to health products intended for animal use should be sent to vetdrugs-medsvet@hc-sc.gc.ca or hc.VHP-PSA.sc@canada.ca.