Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply)
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk to health, safety or the environment;
Therefore, the Minister of Health, pursuant to subsection 30.1(1)Footnote a of the Food and Drugs ActFootnote b, makes the annexed Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).
Ottawa, November 27, 2020
Minister of Health
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- Obligation - records
- Information request
- Obligation to provide information
1 The following definitions apply in this Interim Order.
drug means any of the following drugs that is for human use and for which a drug identification number has been assigned under the Food and Drug Regulations or the ISAD Interim Order:
- (a) drugs included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act;
- (b) prescription drugs, as defined in section A.01.010 of the Food and Drug Regulations;
- (c) drugs that are listed in Schedule C or D to the Food and Drugs Act; and
- (d) drugs that are permitted to be sold without a prescription, as defined in subsection C.01.001(1) of the Food and Drug Regulations, but that are to be administered only under the supervision of a practitioner, as defined in that subsection. (drogue)
establishment licence means an establishment licence issued under subsection C.01A.008(1) of the Food and Drug Regulations. (licence d’établissement)
ISAD Interim Order means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020. (arrêté d’urgence IVPD)
- (a) in respect of a drug for which an authorization has been issued under the ISAD Interim Order, the person that holds the authorization; and
- (b) in respect of any other drug, the person to which a document was issued under subsection C.01.014.2(1) of the Food and Drug Regulations that sets out the drug identification number assigned for the drug. (fabricant)
shortage, in respect of a drug, means a situation in which the manufacturer is unable to meet the demand for the drug in Canada. (pénurie)
2 A person that holds an establishment licence must not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.
Obligations - record
3 If a person that holds an establishment licence distributes a drug to another person for consumption or use outside Canada, the person holding the licence must immediately create — and retain — a detailed record of the information that they relied on to determine that the distribution of the drug is not prohibited by section 2.
4 (1) The Minister may request that the manufacturer of a drug — or any person that holds an establishment licence in respect of a drug — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that
- (a) there is a shortage of the drug or the drug is at risk of going into shortage;
- (b) the information is necessary to establish or assess
- (i) the existence of a shortage or risk of shortage of the drug,
- (ii) the reasons for a shortage or risk of shortage of the drug,
- (iii) the effects or potential effects on human health of a shortage of the drug, or
- (iv) measures that could be taken to prevent or alleviate a shortage of the drug; and
- (c) the manufacturer or person will not provide the information without a legal obligation to do so.
Obligation to provide information
(2) The manufacturer or 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 must be at least 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.
5 The references to the Food and Drug Regulations in paragraphs C.01A.016(1)(a) and (2)(a) of those Regulations are deemed to include a reference to this Interim Order.
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