Forward Regulatory Plan 2022-2024: Regulations Amending the Food and Drug Regulations (Public or Canadian Armed Forces Health Emergencies)

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations Public or Canadian Armed Forces Health Emergencies)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Food and Drug Regulations to facilitate access to a drug that is not available in Canada that could be used by appropriate authorities to treat large populations during a Canadian public or military health emergency.

The proposed amendments would provide a regulatory pathway to facilitate access to drugs that are not available in Canada, for emergency preparedness and response activities undertaken by Canadian public health officials.

These amendments would address a long-standing recommendation of the Office of the Auditor General.

Regulatory cooperation efforts (domestic and international)

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

Potential impacts on Canadians, including businesses

It is anticipated that the proposed amendments would impact public health officials including federal, provincial, territorial or municipal Medical Officers of Health responsible for public health, or the Surgeon General of the Canadian Armed Forces responsible for military health.

Health Canada would expect potential impacts to include ensuring adequate oversight of unapproved drugs to be used on large populations during public health and military emergencies.

Consultations

Health Canada pre-published the proposed changes in Canada Gazette, Part I, on May 11, 2019, for a 70-day comment period.

Health Canada plans to publish the proposed amendments in the Canada Gazette, Part II, in fall 2022.

Additional notes

At the time of pre-publication, this initiative was combined with a complementary initiative. The proposed changes entitled: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) were published in Canada Gazette, Part II, on October 14, 2020.

Further information

Related information can be found on:

Draft Guidance Document: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling

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 2018

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:

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: