Food and Drug Regulations
C.08.007 (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(i) [Repealed, SOR/95-521, s. 3]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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