Health Canada Regulations to Support Coming Into Force of the Cannabis Act

Article by Health Canada

Regulations to support coming into force of the Cannabis Act

Who this information is for

Regulations under the Cannabis Act will establish the rules and standards that will apply to the production, distribution, sale, importation and exportation of cannabis by federal licence holders. Those regulations will be published in the Canada Gazette, Part II, on July 11, 2018.

There are two main sets of regulations under the Cannabis Act:

  • Cannabis Regulations
  • the new Industrial Hemp Regulations

When the new regulations come into force

When the Cannabis Act and its regulations come into force on October 17, 2018, cannabis will cease to be regulated under the Controlled Drugs and Substances Act (CDSA). It will be regulated under the Cannabis Act instead. At that time we will repeal 2 regulations under the Controlled Drugs and Substances Act:

Certain regulations under the Food and Drugs Act will also be amended, including the:

Cannabis Regulations

As set out in the Cannabis Regulations:

  • licences will be required for:
    • cultivating and processing cannabis
    • sale of cannabis for medical purposes
    • analytical testing of and research with cannabis
  • permits will be required to import or export cannabis for:
    • scientific or medical purposes, or
    • industrial hemp
  • licence holders will be subject to strict physical and personnel security requirements
  • plain packaging will be required for cannabis products:
    • the Regulations set out strict requirements for:
      • logos
      • colours
      • branding
    • cannabis products must also be labelled with:
      • mandatory health warnings
      • standardized cannabis symbol
      • specific information about the product
  • access to cannabis for medical purposes will continue to be provided for patients who need it:
    • the Regulations will substantively incorporate the current rules for access to cannabis for medical purposes, as set out in the Access to Cannabis for Medical Purposes Regulations
    • certain changes have been made to create consistency with rules for non-medical use of cannabis, to improve patient access and to reduce the risk of abuse of the system
  • manufacturers of prescription drugs containing cannabis, while primarily subject to the Food and Drugs Act and its Regulations, will also be subject to certain regulatory requirements set out in the Cannabis Regulations

Industrial Hemp Regulations

Industrial hemp is cannabis that contains 0.3% tetrahydrocannabinol (THC) or less in the flowering heads and leaves.

The new Industrial Hemp Regulations under the Cannabis Act set out the requirements for cultivators of industrial hemp. As is currently the case, cultivators of industrial hemp must grow from the hemp varieties approved for commercial cultivation.

While the new Industrial Hemp Regulations are generally consistent with the current Industrial Hemp Regulations:

  • some changes have been made, with the goal of aligning licence requirements to the relatively low risk posed by industrial hemp as compared with other varieties of cannabis
  • the sale of hemp plants (flowers, leaves and branches) to licensed cannabis processors will be permitted, to provide a source of low THC, high cannabidiol (CBD) cannabis products

Consultations

The regulatory framework was built on:

  • existing regulations for current producers of cannabis for medical purposes and industrial hemp
  • extensive consultations undertaken by the Task Force on Cannabis Legalization and Regulation, with:
    • experts
    • patients and advocates
    • employers and industry
    • provinces, territories, and municipalities
    • Indigenous governments and representative organizations

In addition, we undertook consultations with interested parties on a detailed consultation paper entitled Proposed Approach to the Regulation of Cannabis.

During the 60-day public comment period we received more than 3,200 responses to an online questionnaire and 450 written submissions. We also undertook targeted consultations (both in-person and web-based) with:

  • the provinces and territories
  • Indigenous governments and representative organizations
  • the cannabis industry (existing and prospective licensees)
  • public health organizations
  • patients and patient advocates

In March 2018, we published a Summary of Comments Received During the Public Consultation, which summarized the feedback received from thousands of Canadians.

Documents incorporated by reference in the regulations

“Incorporation by reference” is a term used to describe a mechanism that allows a document or list that is not in the text of the regulations to be made a part of the regulations.

Documents incorporated by reference have the force of law.

This is a list of documents that have been incorporated by reference as part of either the Cannabis Regulations or Industrial Hemp Regulations:

The following documents will soon be made available on the Government of Canada website:

  • Consumer Information – Cannabis
  • Standardized Cannabis Symbol
  • Cannabis Health Warning Messages
  • Limits for Residual Solvents in Cannabis Products
  • Tolerance Limits for the Net Weight and Volume Declared on Cannabis Product Labelling
  • Form and Manner Requirements – Documents Provided to the Minister of Health under the Cannabis Act
  • Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis

The following documents are already available on the Government of Canada website at the links below:

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