Health Canada’s Proposed Cannabis Regulatory Framework
Posted: Monday December 11th, 2017
Author: Pinky Mazumder
Bill C-45, the proposed Cannabis Act (the “Act”), was introduced earlier in 2017 and is scheduled to be in force by July 2018. The Act will provide restricted access to cannabis for recreational purposes, as well as regulate its production, importation, exportation, distribution, sale, and possession. The Act will provide provinces and territories will the power to regulate the distribution of cannabis. To date, several provinces have announced their proposed distribution schemes.
On November 2017, Health Canada published a consultation paper on the proposed regulatory framework to support the implementation of the Act titled: the Proposed Approach to the Regulation of Cannabis. The consultation paper is open to the public and stakeholders to share their views and comments on or before January 20th, 2018.
The Act proposes to introduce a system of licensure, permits, and authorization for various activities conducted with cannabis, such as cultivation and research. The purpose of licensure is to allow a diverse yet competitive industry for the production of quality-controlled cannabis products. The proposed Regulations will also establish rules based on public health and safety risks. In addition to licensure, the Regulations will also require certain members of the industry, holding sensitive business information, to be subject to security clearance. The Minister will even be allowed to refuse to grant security clearances upon evaluation of the individual’s associations and past convictions (currently this practice is also in place for medical marijuana production as well).
Cannabis Tracking System
The Act will also establish a Cannabis Tracking System to track the movement of cannabis through the supply chain in order to prevent diversion from the legal market. Information will be required to be reported into the tracking system, to allow for a collection of data on inventory and production of Cannabis in Canada. However, the tracking system will not require the industry to report information on the consumers of their cannabis products. The proposed Regulations will also for the sale of dried cannabis, cannabis oil, and fresh cannabis among other product types, to people 18 years of age and above.
Packaging and Labelling
The proposed Regulations will also establish requirements for the labelling and packaging of cannabis products for safe handling and transportation. In addition, the packaging and labelling of cannabis products will also be required to meet tamper-evident and child-resistant requirements. Moreover, with the intent to curtail the appeal of cannabis to youth, Health Canada will limit the colours and graphics used on the packaging of cannabis products.
Health Products and Cosmetics Containing Cannabis
Currently, manufacturers are required to submit a New Drug Submission for prescription drug products containing cannabis. This regulatory requirement will continue after the coming into force of the Act. In addition, manufacturers may also seek marketing approval for medical devices used for medical cannabis consumption. However it is now also proposed that cannabis may be used in non-prescription drug products and natural health products. For natural health products containing cannabis, Health Canada would impose a strict limit of no more than 10ppm of Tetrahydrocannabinol (THC). For more information on the proposed regulatory framework for cannabis and the consultation paper, please see the References below.
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