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Food and Drug Regulations

Version of section C.08.007 from 2014-05-16 to 2023-01-11:

  •  (1) Where a manufacturer has received a notice of compliance issued in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

    • (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

    • (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

    • (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

    • (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

    • (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

    • (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

    • (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

    • (h) any unusual failure in efficacy of that new drug.

    • (i) [Repealed, SOR/95-521, s. 3]

  • (1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established.

  • (2) A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled.

  • SOR/95-411, s. 10
  • SOR/95-521, s. 3
  • SOR/2011-88, s. 19
  • SOR/2014-125, s. 2
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