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11 November 2020
On 16 October 2020 the minister of health approved the Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19, which introduces new tools to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated by the COVID-19 pandemic.(1) Health Canada has also published a notice, explanatory note and guidance document relating to the interim order.
The interim order authorises the minister to request information from any party that sells a drug, except for personal information in respect of a consumer of said drug, where there are reasonable grounds to believe that:
The person selling the drug can be an individual or a company and the drug can be any drug that is not a veterinary or natural health product. Requests for information will be accompanied by the reason for the request, which will be based on evidence available to the minister. Evidence may, for example, be in the form of:
The minister can request information only that is in the control of the person and cannot require a person to create new information in response to the request.
The requested information must be provided within the time limit specified by the minister, which can be as soon as 24 hours after the request or even sooner if the minister believes there to be a serious and imminent risk of injury to human health.
If the minister has reasonable grounds to believe that the conditions set out in the first three bullets above have been met, terms and conditions may be imposed on the market authorisation holder (MAH) for the drug for the purpose of preventing or alleviating a drug shortage. Examples of possible terms and conditions include identifying alternative sources for raw materials and supplies and reporting on inventory levels on a regular basis. Health Canada will notify MAHs before a term or condition is applied and will work with MAHs to develop the appropriate measures to be applied. Terms and conditions may change as the drug shortage changes and will expire at Health Canada's discretion.
For further information on this topic please contact Eleanor Wilson at Smart & Biggar by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
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