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

Regulations are current to 2019-05-22 and last amended on 2019-05-22. Previous Versions

PART CDrugs (continued)

DIVISION 8 (continued)

New Drugs (continued)

  •  (1) For the purposes of subsection (2), evidence or new information obtained by the Minister includes any information or material filed by any person under 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 Minister 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).

  • (3) 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, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(b)(iii) to conduct an assessment of the new drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

    • (a) the holder fails to comply with the order; or

    • (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health.

  • SOR/95-411, s. 9
  • SOR/2001-203, s. 8
  • SOR/2011-88, s. 18
  • SOR/2018-69, s. 27
  • SOR/2018-84, s. 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

 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

  • (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary;

  • (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately on the manufacturer establishing the record; and

  • (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record.

  • SOR/95-411, s. 11
  • SOR/95-521, s. 4
  • SOR/2014-125, s. 3
  • SOR/2018-84, s. 12

 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer

  • (a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and

  • (b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness.

  • SOR/2011-88, s. 20
  •  (1) Where the Minister has decided

    • (a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or

    • (b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01,

    the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

  • (2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

  • (3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

  • (4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.

  • (4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

  • (5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

  • (6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

  • (7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.

  • (7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

  • (8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.

  • SOR/95-411, s. 12
  • SOR/2001-203, s. 9
  • SOR/2011-88, s. 21
 
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