Cannabis Health Products: Canada

Canada has been in the marijuana spotlight since 2013 when Health Canada implemented regulations for (dried forms of) marijuana for medical purposes. As a follow-up, all eyes are still on Canada as the finish line looms for recreational marijuana, and potential to sell additional product formats besides dried marijuana becomes a reality.

Currently health products and cosmetics containing cannabis are permitted for sale in Canada as long as two conditions are met: no other controlled substance is contained in the same natural health product, and the upper limit of THC in the product does not exceed 10 micrograms per gram (also expressed as 10 parts per million). Applicants seeking approval for their natural health products containing cannabis can make use of pre-cleared information on file at Health Canada to speed up the review process. At this time, the parts of the cannabis plant that may be included in these products are hemp seeds and mature stalks without leaves, flowers or branches. Cannabis flowers on the other hand have been excluded from these regulations based on the fact that are included and regulated under the Controlled Drugs & Substances Act.

Health Canada recently released their Proposed Approach to the Regulation of Cannabis announcement with the natural health product application route being identified as a logical point of entry for health products containing cannabis parts regulated under the CDSA (such as cannabis flowers). Manufacturers filing NHP product license applications to Health Canada should bear in mind that the upper limit of 10 ppm of THC in products would be maintained in order to minimize potential risks. Applicants should also be prepared to provide comprehensive safety and efficacy information with all applications, including support for proposed indication, recommended dose and target populations. While the task at hand may seem daunting at first sight, the opportunity to file cannabis health product applications via the NHP route is encouraging given that these set of regulations are modern (relative to the Food & Drug Regulations) with reasonable review times; all in all an encouraging step in the right direction. Those groups with experience filing Class III NHP product license applications to Health Canada will be in an advantageous position once the final adjustments are made to the Natural Health Product Regulations.