Forward Regulatory Plan 2022-2024: Proposed Approach to the Regulation of Health Products Containing Cannabis that would not require practitioner oversight

Title of Regulatory Initiative

Proposed Approach to the Regulation of Health Products Containing Cannabis that would not require practitioner oversight

Enabling Act

Food and Drugs Act

Description

The proposed regulatory amendments will be informed by the recommendations provided by the Science Advisory Committee on Health Products Containing Cannabis, and Departmental policy decision-making. The proposed regulatory amendments would enable health products containing cannabis that would not require the oversight of a practitioner (i.e., available without a prescription).

The proposed amendments would enable safe, effective and high quality health products containing cannabis that would not require the oversight of a practitioner.

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts on Canadians, including businesses

The proposed amendments would apply to businesses interested in the sale of heath products containing cannabis in Canada.

It is anticipated that this proposal would result in access to safe, effective and high quality health products containing cannabis without the need for a prescription, as well as opportunities for businesses interested in expanding into the sale of these products in Canada.

Consultations

Stakeholder engagement and consultation was undertaken in 2019.

Health Canada launched the Science Advisory Committee for Health Products Containing Cannabis in 2020.

Although regulatory amendments would be necessary to accomplish the objective of this initiative, Health Canada is gathering external scientific advice on the appropriate evidence standards required to demonstrate safety, efficacy and quality for these products.

Health Canada intends to engage further with key stakeholders in 2022.

Further information

Related information can be found on:

Science Advisory Committee for Health Products Containing Cannabis

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 2019

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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