Forward Regulatory Plan 2021-2023: 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 Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)
Enabling Act
Food and Drugs Act
Description
Current emergency provisions in the Food and Drug Regulations do not cover emergency preparedness and response activities undertaken by federal, provincial, territorial or municipal Public Health Officials responsible for public health or the Surgeon General of the Canadian Armed Forces responsible for military health.
A new regulatory framework is proposed that would provide appropriate authorities to reflect current operations, facilitating access to unauthorized drugs that could be used to treat mass populations during a Canadian public or military health emergency (e.g., pandemic influenza vaccine, antivirals, etc.).
Regulatory cooperation efforts (domestic and international)
This initiative is not subject to a regulatory cooperation work plan with provincial, territorial or foreign regulatory partners.
Potential impacts on Canadians, including businesses
These amendments will address a long-standing recommendation of the Office of the Auditor General. They will allow for adequate oversight of unapproved drugs to be used on large populations during public health and military emergencies, thereby affording more protection to Canadians.
Consultations
Health Canada engaged the Public Health Agency of Canada (PHAC) and Canadian Armed Forces (CAF) throughout the development of the proposed regulations. In addition, provinces and territories were engaged through the Chief Medical Officers of Health Network.
A regulatory proposal was pre-published in the Canada Gazette, Part I on May 11, 2019, for a 70-day comment period. In addition, a draft guidance document that provided information about the interpretation of the proposal and the process to be followed was also published at that time.
The proposal for regulations concerning the Sale of Drugs for Public or Canadian Armed Forces Health Emergencies was pre-published with a complementary proposal concerning the Sale of a New Drug for Emergency Treatment, which was published in Canada Gazette, Part II, on October 14, 2020.
The regulations concerning the Sale of Drugs for Public or Canadian Armed Forces Health Emergencies are expected to be published in Canada Gazette Part II, in fall 2021. At this time, the final guidance document will also be published.
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, 2018
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