Food and Drug Regulations

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• (d) [Repealed, SOR/2014-158, s. 13]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