Forward Regulatory Plan 2020-2022: 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

Health Canada sought input through a consultation (June - September 2019) to seek feedback from Canadians, as well as the cannabis and health products industries, regarding the kinds of products they would be interested in manufacturing, selling or purchasing, should a legal pathway to market for these products be established.  Following the consultation, Health Canada is gathering external scientific advice through a science advisory committee on health products containing cannabis on the appropriate evidence standards required to demonstrate safety and efficacy.

The potential regulatory approach would have, as a key objective, that the public health and safety requirements of the Food and Drugs Actand the Cannabis Actare met. Health Canada will consider the advice from the science advisory committee, as well as feedback from the spring 2019 consultation in the development of a potential regulatory approach.

Any decision regarding access to non-prescription health products containing cannabis will be based on evidence. Advice sought from the Committee will be considered by the Department to determine appropriate evidence standards for these types of products and will help Canadians make informed choices to maintain and improve their health.

Any regulatory proposals are expected to follow regular consultation procedures, including publication of draft regulations in Canada Gazette, Part I.

Regulatory cooperation efforts (domestic and international)

N/A. Cannabis remains a controlled substance internationally, so these regulations are expected to have a minimal impact, if any, outside of Canada.

Potential impacts on Canadians, including businesses

Feedback obtained from this public policy consultation and from the science advisory committee will support Health Canada in developing a potential regulatory approach for non-prescription health products containing cannabis in a way that protects both public health and safety, and supports Canadians in making informed decisions about their health.

Consultations

On June 19, 2019, Health Canada launched an on-line consultation to obtain feedback from Canadians and interested stakeholders on the potential market for cannabis health products that would not require practitioner oversight. The 75 day comment period will closed September 3, 2019.

From February 27, 2020 to May 11, 2020, Health Canada launched a call for applications for the Science Advisory Committee for Health Products Containing Cannabis to provide the Department with scientific and clinical advice for health products containing cannabis that would not require a prescription. Health Canada has assessed all applications and has notified applicants of the committee’s membership decisions.

The summary report of the June 19, 2019 online consultation was published on September 25, 2020 and key stakeholders were notified of its publication.

Further information

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: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

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

April 1, 2019

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