Document ID: chunk:federal_register_of_legislation:F2023L01667:clause:1_15:p1
Version: federal_register_of_legislation:F2023L01667
Segment Type: clause
Provision Reference: sch 1 cl 15 (pt 1/3)
Character Range: 8180–15195

15  Therapeutic goods, if:                                                                                                                                                                                                                                     (a) the sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that:
    (a) the goods are:                                                                                                                                                                                                                                         (i) the goods conform with any standard applicable to the goods, or are imported or supplied (as the case may be) with the consent of the Secretary under section 14 or 14A of the Act; and
    (i) therapeutic vaping substances; or                                                                                                                                                                                                                      (ii) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and
    (ii) therapeutic vaping substance accessories; or                                                                                                                                                                                                          (b) the sponsor notice must be given:
    (iii) a therapeutic vaping kit; or                                                                                                                                                                                                                         (i) for goods imported into Australia—before importing the goods; or
    (iv) goods in a therapeutic vaping pack; and                                                                                                                                                                                                               (ii) for goods manufactured in Australia—before the goods are released for supply in Australia; and
    (b) the goods are not, or do not include, any medicinal cannabis products; and                                                                                                                                                                             (c) the sponsor holds information or evidence to support the statements made in the sponsor notice; and
    (c) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and                                                                                                                                          (d) neither of the statements made in the sponsor notice is incorrect; and
    (d) the sponsor of the goods, and any other person involved in the wholesale or retail supply of the goods, intend the goods to be supplied to the ultimate consumer of the goods in accordance with an approval or authority under section 19 of the Act  (e) the goods are not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the goods be stopped or should cease because:
                                                                                                                                                                                                                                                               (i) the Secretary is satisfied that the supply compromises public health and safety; or
                                                                                                                                                                                                                                                               (ii) the Secretary is satisfied that the goods do not conform with a standard applicable to the goods; and
                                                                                                                                                                                                                                                               (f) the sponsor must:
                                                                                                                                                                                                                                                               (i) if requested by the Secretary, give the Secretary the information or evidence referred to in paragraph (c); and
                                                                                                                                                                                                                                                               (ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made); and
                                                                                                                                                                                                                                                               (g) for goods manufactured in Australia—the goods are manufactured by:
                                                                                                                                                                                                                                                               (i) the holder of a licence; or
                                                                                                                                                                                                                                                               (ii) a person who is exempt in accordance with subsection 34(2) of the Act from the operation of Part 3‑3 of the Act in relation to the manufacture of the goods; and
                                                                                                                                                                                                                                                               (h) the goods may be supplied to a person who is not the ultimate consumer of the goods only if:
                                                                                                                                                                                                                                                               (i) the supply is to the holder of a licence; or
                                                                                                                                                                                                                                                               (ii)