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

 Despite sections C.08.002 and C.08.003, no manufacturer or importer shall sell a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 except to

  • (a) the Government of Canada or the government of a province for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative; or

  • (b) a municipal government, or an institution of such a government, on receipt of a written order signed by a senior official of the government or institution or by his or her duly authorized representative.

  • SOR/2011-88, s. 11.
  •  (1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product,

    • (a) the new drug is the pharmaceutical equivalent of the Canadian reference product;

    • (b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;

    • (c) the route of administration of the new drug is the same as that of the Canadian reference product; and

    • (d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.

  • (2) An abbreviated new drug submission or an abbreviated extraordinary use new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:

    • (a) the information and material described in

      • (i) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), in the case of an abbreviated new drug submission, and

      • (ii) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission;

    • (b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;

    • (c) evidence from the comparative studies conducted in connection with the submission that the new drug is

      • (i) the pharmaceutical equivalent of the Canadian reference product, and

      • (ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;

    • (d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

    • (e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.

  • (3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission or an abbreviated extraordinary use new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:

    • (a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;

    • (b) samples of the ingredients of the new drug;

    • (c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and

    • (d) any additional information or material respecting the safety and effectiveness of the new drug.

  • (4) For the purposes of this section, in the case of an abbreviated new drug submission, a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01 is not a Canadian reference product.

  • SOR/95-411, s. 5;
  • SOR/2011-88, s. 12;
  • SOR/2014-158, s. 12.
  •  (1) Despite section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended under section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary use new drug submission, unless

    • (a) the manufacturer of the new drug has filed with the Minister a supplement to that submission;

    • (b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement; and

    • (c) the notice of compliance in respect of the supplement has not been suspended under section C.08.006.

    • (d) [Repealed, SOR/2014-158, s. 13]

  • (2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:

    • (a) the description of the new drug;

    • (b) the brand name of the new drug or the identifying name or code proposed for the new drug;

    • (c) the specifications of the ingredients of the new drug;

    • (d) the plant and equipment used in manufacturing, preparation and packaging the new drug;

    • (e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;

    • (f) the tests applied to control the potency, purity, stability and safety of the new drug;

    • (g) the labels used in connection with the new drug;

    • (g.1) in the case of a new drug for human use, its packages;

    • (h) the representations made with regard to the new drug respecting

      • (i) the recommended route of administration of the new drug,

      • (ii) the dosage of the new drug,

      • (iii) the claims made for the new drug,

      • (iv) the contra-indications and side effects of the new drug, and

      • (v) the withdrawal period of the new drug; and

    • (i) the dosage form in which it is proposed that the new drug be sold.

  • (3) A supplement to a submission referred to in subsection (1), with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.

  • (3.1) A supplement to a submission referred to in subsection (1) shall contain, as the case may be,

    • (a) if, due to a matter specified in subsection (2) — other than the brand name of a new drug for human use — that the supplement concerns, it is necessary to modify a new drug’s labels:

      • (i) in the case of a new drug for veterinary use, a draft of every label to be used in connection with the new drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug, or

      • (ii) in the case of a new drug for human use, mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages; or

    • (b) if the supplement concerns the brand name of a new drug for human use:

      • (i) an assessment as to whether there is a likelihood that the new drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the new drug and the brand name, common name or proper name of any of those products:

        • (A) a drug in respect of which a drug identification number has been assigned,

        • (B) a radiopharmaceutical, as defined in section C.03.201, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01, and

        • (C) a kit, as defined in section C.03.205, in respect of which a notice of compliance has been issued under section C.08.004 or C.08.004.01, and

      • (ii) mock-ups of every label to be used in connection with the new drug — including any package insert and any document that is provided on request and that sets out supplementary information on the use of the new drug — and mock-ups of the new drug’s packages.

  • (4) If a supplement to an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission concerns a matter specified in subparagraph (2)(h)(iii), the supplement shall contain the attestation and supporting information referred to in paragraph C.08.002.01(2)(a).

  • SOR/85-143, s. 2;
  • SOR/93-202, s. 25;
  • SOR/95-411, s. 6;
  • SOR/2011-88, s. 13;
  • SOR/2014-158, s. 13.
 
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