Forthcoming Regulatory Changes in the Cannabis/NHP Interface

On November 22, 2017, Health Canada proposed their new approach to the regulation of cannabis in Canada. If the proposed framework passes into regulation unchanged, the production and processing of cannabis (as an ingredient) will fall under the Cannabis Act, while the manufacturing of cannabis-containing natural health products (NHPs), pharmaceuticals, medical devices, and veterinary health products will fall under the Food and Drugs Act. This overlap between the two regulatory bodies presents an incredible opportunity for Canadian licensed producers (LPs) to integrate finished health products into their businesses, an initiative necessitating careful consideration of the site licensing, formula, marketing, manufacturing, and product licensing requirements of the NHP framework. For the NHP industry, the introduction of cannabis (and its derivatives) as a new permitted ingredient provides development opportunities for products in various dosage forms (topicals, patches, capsules, tinctures etc.) to alleviate non-serious conditions such as social anxiety, sleep disturbances, and appetite-loss, among others. The proposed framework indicates NHP manufacturers will require both the existing NHP manufacturing site license as well as a processor license under the cannabis framework to legally process, package and label products with cannabis. This presentation will provide an update on the proposed Cannabis Act's intersection with the existing regulatory frameworks for NHPs, pharmaceuticals, medical devices and veterinary health products, highlighting opportunities for businesses on both sides to enter the new industry of cannabis health products in Canada. Moreover, future opportunities for LPs and food industry to integrate cannabis and edibles will also be discussed.