Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_15:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 15 (pt 1/6)
Character Range: 584814–590594

15        Therapeutic goods, if:                                                                                                                                                                                                                                                                                                                                                                  (a) the sponsor must give the sponsor notice to the Secretary in a form approved in writing by the Secretary; and
          (a) the goods are:                                                                                                                                                                                                                                                                                                                                                                      (b) the sponsor notice must be given as follows:
          (i) therapeutic vaping substances; or                                                                                                                                                                                                                                                                                                                                                   (i) for goods imported into Australia on or after 1 March 2024—before the goods are imported;
          (ii) therapeutic vaping substance accessories; or                                                                                                                                                                                                                                                                                                                                       (ii) for goods imported into Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and
          (iii) a therapeutic vaping kit; or                                                                                                                                                                                                                                                                                                                                                      (iii) for goods manufactured in Australia on or after 1 March 2024—before the goods are first supplied in Australia; and
          (iv) goods in a therapeutic vaping pack; and                                                                                                                                                                                                                                                                                                                                            (iv) for goods manufactured in Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and
          (b) the goods are not, or do not include, any medicinal cannabis products; and                                                                                                                                                                                                                                                                                                          (c) the sponsor holds information or evidence to support:
          (c) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and                                                                                                                                                                                                                                                                       (i) the statement made in the sponsor notice under subparagraph (e)(ii) of column 2 of this item; and
          (d) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—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; and  (ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (e)(i) of column 2 of this item; and
          (e) the sponsor has given the Secretary a notice (the sponsor notice) stating that:                                                                                                                                                                                                                                                                                                     (iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;
          (i) the goods conform with each standard (as in force from time to time) that is 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                                                                                                                                                     including, in relation to a statement that