C.08.006. (1) For the purposes of this section, evidence or new information obtained by the Minister includes any information or material filed by any person pursuant to Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.
(2) The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer 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 if the Minister considers
(a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from
(i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or
(ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued;
(b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer;
(c) that the submission or supplement contained an untrue statement of material fact;
(d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records;
(e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug;
(f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Director specifying the respect in which the labelling is false or misleading or incomplete; or
(g) that, in the case of a new drug for extraordinary use, the manufacturer has not adhered to the plan referred to in subparagraph C.08.002.01(2)(b)(ix).
- SOR/95-411, s. 9;
- SOR/2001-203, s. 8;
- SOR/2011-88, s. 18.
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]
(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.
- Date modified: