Forward Regulatory Plan 2022-2024: Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)
Title of Regulatory Initiative
Regulations Amending Certain Regulations Concerning the Sales of Drugs (Public or Canadian Armed Forces Health Emergencies)
Enabling 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) which were published in Canada Gazette, Part II, on October 14, 2020.
Further information
Related information can be found on:
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:
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