Food and Drug Regulations — C.08.002
ion 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 new drug submission. (2.1) A manufacturer may file, for a public health emergency drug, a new drug submission that does not meet the requirements set out in paragraphs (2)(g) and (h) if the submission contains (a) a statement that the submission contains evidence to establish that the requirement set out in paragraph (b) is met; and (b) 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. (2.2) A manufacturer may file, for a public health emergency drug for human use, a new drug submission that does not meet the requirements set out in paragraph (2)(j.1) if the submission 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. (2.3) If, at the time a new drug submission is filed for a public health emergency drug, the manufacturer is unable to provide the Minister with information or material that is referred to in any of paragraphs (2)(e) to (k), (m) and (n) and (2.1)(b) and subsection (2.2) — and, as applicable, the corresponding material referred to in paragraphs C.08.005.1(1)(b) to (d) — or any of that information or material is incomplete, the manufacturer must 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. (2.4) Subsections (2.1) to (2.3) apply only if (a) the new drug submission contains a statement that the submission is for a public health emergency drug; and (b) the purpose and conditions of use specified in the submission relate only to a condition described in the List of Conditions that Threaten Public Health and the submission contains a statement to that effect. (2.5) Subsections (2.1) to (2.3) do not apply if a notice of compliance is being sought on the basis of a direct or indirect comparison between the new drug and another drug. (3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a 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. SOR/85-143, s. 1; SOR/93-202, s. 24; SOR/95-411, s. 4; SOR/2011-88, s. 10; SOR/2014-158, s. 10; SOR/2017-259, s. 22; SOR/2018-69, s. 33(F); SOR/2018-84, s. 8(F) SOR/2021-45, s. 14 SOR/2024-238, s. 26