Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1) of the Food and Drugs Act, makes the annexed Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19.

Ottawa, October 16, 2020
Patty Hajdu
Minister of Health

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Definitions    

The following definitions apply in this Interim Order.

COVID-19
means the coronavirus disease 2019. (COVID-19)
drug
means a drug other than
  1. a veterinary health product as defined in subsection C.01.001(1) of the Food and Drug Regulations; or
  2. a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations. (drogue)

Information request

2 (1) The Minister may request that a person that sells a drug provide the Minister with information that is in the person’s control if the Minister has reasonable grounds to believe that

  1. there is a shortage of the drug in Canada or the drug is at risk of going into shortage;
  2. the shortage or risk of shortage is caused or exacerbated, directly or indirectly, by COVID-19;
  3. a shortage of the drug poses or could pose a risk of injury to human health;
  4. the information is necessary to establish or assess
    1. the existence of a shortage or risk of shortage of the drug,
    2. the reasons for a shortage or risk of shortage of the drug,
    3. the effects or potential effects on human health of a shortage of the drug, or
    4. measures that could be taken to prevent or alleviate a shortage of the drug; and
  5. the person will not provide the information without a legal obligation to do so.

Obligation to provide information

(2) The person must provide the requested information electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister. The time limit cannot be less than 24 hours after the request is made unless the Minister has reasonable grounds to believe that there is a serious and imminent risk of injury to human health.

Restriction

(3) The information that may be requested does not include personal information, as defined in section 3 of the Privacy Act, in respect of a consumer of the drug.

Terms and conditions

3 (1) The Minister may, at any time, for the purpose of preventing or alleviating a shortage of a drug, impose terms and conditions on any of the following authorizations — or amend those terms and conditions — if the Minister has reasonable grounds to believe that the conditions set out in paragraphs 2(1)(a) to (c) are met:

  1. a drug identification number that is assigned for the drug under subsection C.01.014.2(1) of the Food and Drug Regulations;
  2. an authorization that authorizes the sale of the drug and that is issued under another interim order made under subsection 30.1(1) of the Food and Drugs Act in relation to COVID-19, if a drug identification number is assigned in respect of the drug under the other interim order.

Clarification

(2) For greater certainty,

  1. the terms and conditions may require that measures be taken to prevent or alleviate a shortage of the drug; and
  2. subsection (1) does not limit any other power to impose terms and conditions on an authorization referred to in paragraph (1)(a) or (b).
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