Food and Drug Regulations — C.08.003
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. 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; SOR/2017-259, s. 23; SOR/2018-69, s. 33(F); SOR/2018-84, s. 9(F) SOR/2024-238, s. 29