Food and Drug Regulations — C.08.003
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 (d) [Repealed, SOR/2014-158, s. 13] (2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following: (a) the description of the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 t