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;
(c) the notice of compliance in respect of the supplement has not been suspended pursuant to section C.08.006; and
(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label.
(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;
(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.
(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).
- SOR/85-143, s. 2;
- SOR/93-202, s. 25;
- SOR/95-411, s. 6;
- SOR/2011-88, s. 13.
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