Food and Drug Regulations

C.01.053 The Minister’s power to make an order under section 21.32 of the Act is subject to the following conditions:

• (a) the order shall relate to a drug;

• (b) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug:

  • (i) a drug identification number that has been assigned under subsection C.01.014.2(1),

  • (ii) an establishment licence that has been issued under subsection C.01A.008(1), and

  • (iii) a notice of compliance that has been issued under section C.08.004 or C.08.004.01;

• (c) the Minister shall have reasonable grounds to believe that

  • (i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), there are significant uncertainties relating to the benefits or harms associated with the drug,

  • (ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) who is an importer, the manner in which one or more of the following activities is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug:

    • (A) importation, within the meaning of subsection C.01A.001(1), of the drug,

    • (B) fabrication or packaging/labelling, within the meaning of subsection C.01A.001(1), of the drug outside Canada, or

    • (C) testing of the drug outside Canada,

  • (iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) other than an importer, the manner in which an activity that is authorized under the authorization is conducted has introduced significant uncertainties relating to the benefits or harms associated with the drug,

  • (iv) the holder of the therapeutic product authorization is unable to provide the Minister with information that is sufficient to manage those uncertainties, and

  • (v) the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the authorization, do not allow for sufficient information to be obtained to manage those uncertainties; and

• (d) the Minister shall take into account the following matters:

  • (i) whether the activities that the holder of the therapeutic product authorization will be ordered to undertake are feasible, and

  • (ii) whether there are less burdensome ways of obtaining additional information about the drug’s effects on health or safety.