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Food and Drug Regulations

Version of section C.01.052 from 2018-04-23 to 2021-02-24:

  •  (1) The Minister’s power to make an order under section 21.31 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; and

    • (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), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued,

      • (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 may present a risk of injury to health 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, or

      • (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 may present a risk of injury to health associated with the drug.

  • (2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act,

    • (a) provide the holder of the therapeutic product authorization with the results of the examination; and

    • (b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.

  • SOR/2018-84, s. 3
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