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

C.08.002.02 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.

• C.08.002.1 (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.

• C.08.003 (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.

• (3.01) If clinical trial data that is included in a supplement to a new drug submission is broken down by population subgroup in an application made to the European Medicines Agency or the United States Food and Drug Administration to authorize the sale of the new drug, the data must be broken down in the same manner in the supplement.

• (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 another drug for which a drug identification number has been assigned 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 the other drug, 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).

• (5) The manufacturer may file, for a public health emergency drug, a supplement to the new drug submission referred to in subsection (1) that does not contain all of the information and material that is required under subsection (3) if the supplement contains

  • (a) a statement that the supplement contains evidence to establish that the requirement set out in paragraph (b) is met; and

  • (b) with respect to the matters that are significantly different from those contained in the submission, sufficient evidence to support the conclusion that the benefits associated with the public health emergency drug outweigh the risks associated with it for the purpose and under the conditions of use recommended, with consideration given to the uncertainties relating to those benefits and risks as well as the public health need related to the applicable condition described in the List of Conditions that Threaten Public Health.

• (6) The manufacturer may file, for a public health emergency drug for human use, a supplement to the new drug submission referred to in subsection (1) that does not meet the requirements set out in subparagraph (3.1)(a)(ii) or (b)(ii) if the supplement contains a draft of every label to be used in connection with the drug, including any package insert and any document provided on request that sets out supplementary information on the use of the drug.

• (7) If, at the time the manufacturer files, for a public health emergency drug, a supplement to the new drug submission referred to in subsection (1), the manufacturer is unable to provide the Minister with information or material that relates to any of the matters referred to in paragraphs (2)(d) to (h) and (5)(b) and subsection (6) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or if any of that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when they will provide the Minister with the missing information or material.

• (8) Subsections (5) to (7) apply only if

  • (a) the supplement contains a statement that the supplement is for a public health emergency drug; and

  • (b) the purpose and conditions of use specified in the supplement relate only to a condition described in the List of Conditions that Threaten Public Health and the supplement contains a statement to that effect.

• (9) Subsections (5) to (7) do not apply if a notice of compliance in respect of the supplement is being sought on the basis of a direct or indirect comparison between the new drug and another drug.

• C.08.003.01 (1) The following definitions apply in this section.

  submission

  submission means

  • (a) a new drug submission that is filed under section C.08.002;

  • (b) an extraordinary use new drug submission that is filed under section C.08.002.01;

  • (c) an abbreviated new drug submission that is filed under section C.08.002.1; or

  • (d) an abbreviated extraordinary use new drug submission that is filed under section C.08.002.1. (présentation)

  supplement

  supplement means a supplement to a submission that is filed under section C.08.003. (supplément)

• (2) Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 and subject to subsection (3), the manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to any new drug in respect of which an authorization was issued under the ISAD Interim Order.

• (3) Subsection (2) does not prevent the manufacturer of a new drug from filing a submission or supplement for the new drug on the basis of a direct or indirect comparison to another new drug in respect of which an authorization was issued under the ISAD Interim Order if

  • (a) a notice of compliance is issued under section C.08.004 or C.08.004.01 in respect of a submission or supplement for that other new drug; and

  • (b) the comparison is in respect of the matters that were approved by the notice of compliance.

C.08.003.1 In examining 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 Minister may, for the purpose of assessing the safety and effectiveness of the new drug for which the submission or supplement was filed, examine

• (a) information or material provided by any person under the Act;

• (b) information or material obtained from sites at which the new drug or any active ingredient, as defined in subsection C.01A.001(1), of the new drug is or is proposed to be fabricated or packaged/labelled within the meaning of those terms in that subsection, or tested; and

• (c) information or material obtained directly or indirectly from a foreign regulatory authority, as defined in subsection C.10.001(1).

• C.08.004 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (2) If a new drug submission or an abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or within any longer period specified by the Minister.

• (3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,

  • (a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

  • (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

• (4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.