Food and Drug Regulations

Version of section C.01.014.6 from 2018-04-23 to 2018-06-12:

  •  (1) The Minister shall cancel the assignment of a drug identification number for a drug if

    • (a) the person to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number advises under section C.01.014.7 that they discontinued the sale of the drug; or

    • (c) the Minister determines that the product for which the drug identification number has been assigned is not a drug.

  • (2) The Minister may cancel the assignment of a drug identification number for a drug if

    • (a) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number contravenes section C.01.014.5;

    • (b) the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number has been notified under section C.01.013 that the evidence that they submitted with respect to the drug is not sufficient; or

    • (c) the drug is a new drug in respect of which the notice of compliance has been suspended under section C.08.006.

  • (3) The Minister may cancel the assignment of a drug identification number for a drug if, after he or she has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(b)(i) or (iii) to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

    • (a) the holder fails to comply with the order; or

    • (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health.

  • (4) For greater certainty, the Minister’s power to cancel the assignment of a drug identification number

    • (a) under paragraph (2)(b) is not affected by his or her power to cancel the assignment of such a number under subsection (3); and

    • (b) under subsection (3) is not affected by his or her power to cancel the assignment of such a number under paragraph (2)(b).

  • SOR/81-248, s. 2;
  • SOR/2016-139, s. 3;
  • SOR/2018-69, s. 27;
  • SOR/2018-84, s. 1.
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