Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2016-04-03 and last amended on 2016-02-09. Previous Versions

  •  (1) Every manufacturer who files a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use shall, in addition to any information and material that is required under section C.08.002, C.08.002.01, C.08.002.1, C.08.003 or C.08.005, include in the submission or supplement

    • (a) a copy of all clinical case reports respecting any subject of a study included in the submission or supplement if that subject has died, suffered a serious adverse reaction or an unexpected adverse reaction, or the study, insofar as it relates to this subject, has not been completed;

    • (b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement;

    • (c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and

    • (d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement.

  • (2) A sectional report referred to in paragraph (1)(b) shall include

    • (a) a summary of each study included in the submission or supplement;

    • (b) a summary of any additional information or material filed to amend the submission or supplement; and

    • (c) where raw data is available to the manufacturer in respect of a study,

      • (i) a summary of the data,

      • (ii) a cross-referencing of the data to the relevant portions of the sectional report,

      • (iii) a description of the conditions under which the experiments from which the data were obtained were conducted,

      • (iv) the details of the data treatment process, and

      • (v) the results and conclusions of the study.

  • (3) The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports.

  • (4) The submission certificate referred to in paragraph (1)(d) shall

    • (a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and

    • (b) be signed and dated by

      • (i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and

      • (ii) the senior medical or scientific officer of the manufacturer.

  • (5) No person shall sign a submission certificate if a sectional report, comprehensive summary or any information or material included in the submission or supplement, or any additional information and material filed to amend the submission or supplement,

    • (a) is false or misleading; or

    • (b) contains omissions that may affect its accuracy and completeness.

  • (6) Every manufacturer who has filed a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use and who has any relating clinical case reports or raw data that were not included in the submission or supplement shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister.

  • SOR/85-143, s. 5;
  • SOR/92-543, s. 1;
  • SOR/94-689, s. 2(F);
  • SOR/95-411, s. 8;
  • SOR/2001-203, s. 7;
  • SOR/2011-88, s. 17.
  •  (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.
  •  (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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