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• (i) [Repealed, SOR/95-521, s. 3]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.