List of Conditions that Threaten Public Health in Canada
The List of Conditions that Threaten Public Health in Canada is an incorporated by reference (IbR) List published on the Government of Canada’s website. This list is IbR into paragraph C.08.003(2)(b.1) of the Food and Drug Regulations (Regulations). Health Canada maintains and updates this list as required.
Conditions on the List of Conditions that Threaten Public Health are listed once the Minister of Health has determined the criteria outlined in C.08.001.2 of the Regulations as well as has reasonable grounds to believe that:
(a) the condition presents, or is the result of, a significant risk to public health in Canada; and
(b) immediate action is required to deal with the risk.
This list is further IbR in the Regulations in sections C.01A.005, C.01A.006, C.01A.008, C.08.001.1 of the definition of public health emergency drug, C.08.001.2, C.08.001.3, and C.08.002.
A listed condition is eligible for a rolling review, modified requirements and terms and conditions. A sponsor of a drug included on this list may file a new drug submission or a supplement to a new drug submission.
For more information, please refer to the following guidance:
Guidance on the Food and Drug Regulations for Public Health Emergency Drugs
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