Food and Drug Regulations

C.10.001 (1) The following definitions apply in this section and in section C.10.002.

foreign regulatory authority

foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction. (autorité réglementaire étrangère)

public health official

public health official means

• (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;

• (b) the Chief Medical Officer of Health, or equivalent, of a province;

• (c) the Surgeon General of the Canadian Armed Forces; or

• (d) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

(2) Despite sections A.01.040 and C.01.004.1, any person who holds an establishment licence that authorizes the importation of a drug may import a drug for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, or for which a drug identification number has not been assigned under subsection C.01.014.2(1), if the following conditions are met:

• (a) a public health official has, within the past year, notified the Minister in writing of

  • (i) an urgent public health need for the immediate use of the drug within their jurisdiction, and

  • (ii) the intended use or purpose of the drug;

• (b) the drug is authorized by a foreign regulatory authority in the United States, Switzerland or the European Union to be sold for the same use or purpose as that described under subparagraph (a)(ii);

• (c) the drug is in the same category as the category for which the licence was issued;

• (d) the drug is imported directly from the country in which it is authorized to be sold by the foreign regulatory authority; and

• (e) the drug is one for which the following information is set out in the List of Drugs for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time:

  • (i) brand name,

  • (ii) medicinal ingredients,

  • (iii) dosage form,

  • (iv) strength,

  • (v) route of administration, and

  • (vi) identifying code or number, if any, assigned in the country in which the drug was authorized for sale.

(3) Sections C.01A.006 and C.01A.007 do not apply in respect of the importation of a drug under subsection (2).

(4) For greater certainty, a licensee may, despite subsection C.01A.004(1), import a drug under subsection (2) without having their licence amended under section C.01A.006.

(5) Divisions 2 to 4, other than the following provisions, do not apply to the importation of a drug under subsection (2):

• (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;

• (b) section C.02.006;

• (c) subsection C.02.012(1);

• (d) sections C.02.013 and C.02.014;

• (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;

• (f) subsection C.02.021(1) as it applies to the storage of the drug by the licensee;

• (g) subsection C.02.022(1);

• (h) section C.02.023;

• (i) subsections C.02.024(1) and C.02.025(1);

• (j) section C.03.013; and

• (k) section C.04.001.1 as it applies to the storage of the drug by the licensee.