Food and Drug Regulations

C.08.002 (1) No person shall sell or advertise a new drug unless

• (a) the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister;

• (b) the Minister has issued, under section C.08.004 or C.08.004.01, a notice of compliance to the manufacturer of the new drug in respect of the submission; and

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

• (d) [Repealed, SOR/2014-158, s. 10]

(2) A 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) a description of the new drug and a statement of its proper name or its common name if there is no proper name;

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

• (c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;

• (d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;

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

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

• (g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

• (h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;

• (i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;

• (j) 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;

• (j.1) 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;

• (k) a statement of all the representations to be made for the promotion of the new drug respecting

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

  • (ii) the proposed dosage of the new drug,

  • (iii) the claims to be made for the new drug, and

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

• (l) a description of the dosage form in which it is proposed that the new drug be sold;

• (m) 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;

• (n) in the case of a new drug intended for administration to food-producing animals, the withdrawal period of the new drug; and

• (o) in the case of a new drug for human use other than a designated COVID-19 drug, 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.

(2.1) A manufacturer may file, for a designated COVID-19 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 designated COVID-19 drug outweigh the risks 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 COVID-19.

(2.2) A manufacturer may file, for a designated COVID-19 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 designated COVID-19 drug, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the designated COVID-19 drug.

(2.3) If, at the time a new drug submission is filed for a designated COVID-19 drug, the manufacturer is unable to provide the Minister with information or material referred to in any of paragraphs (2)(e) to (k), (m) and (n) or in paragraph (2.1)(b) or subsection (2.2) or that information or material is incomplete, the manufacturer shall provide the Minister, at that time, with a plan that specifies how and when the manufacturer will provide the Minister with the missing information or material.

(2.4) Subsections (2.1) to (2.3) apply if

• (a) the new drug submission contains a statement that the submission is for a designated COVID-19 drug; and

• (b) the purpose and conditions of use specified in the new drug submission in respect of the designated COVID-19 drug relate only to COVID-19 and the submission contains a statement to that effect.

(2.5) Subsections (2.1) to (2.3) do not apply if the manufacturer is seeking a notice of compliance for a designated COVID-19 drug on the basis of a direct or indirect comparison between the designated COVID-19 drug and another designated COVID-19 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.