Document ID: chunk:federal_register_of_legislation:F2023L01667:clause:2_9:p1
Version: federal_register_of_legislation:F2023L01667
Segment Type: clause
Provision Reference: sch 2 cl 9 (pt 1/3)
Character Range: 30130–35284

9  Part 2 of Schedule 4 (at the end of the table)
Add:
2.17  Medical device that is:                                                                                                          (a) The sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that:
      (a) a therapeutic vaping device; or                                                                                              (i) the device is intended, by the person under whose name the device is or is to be supplied, only to administer or contain a therapeutic vaping substance whose only indications are use for smoking cessation or the management of nicotine dependence; and
      (b) a therapeutic vaping device accessory                                                                                        (ii) the device complies with the essential principles, or is imported or supplied (as the case may be) with the consent of the Secretary under section 41MA or 41MAA of the Act.
                                                                                                                                       (b) The sponsor notice must be given:
                                                                                                                                       (i) for a device imported into Australia—before importing the device; or
                                                                                                                                       (ii) for a device manufactured in Australia—before the device is first supplied in Australia.
                                                                                                                                       (c) The sponsor holds information or evidence to support the statements made in the sponsor notice.
                                                                                                                                       (d) Neither of the statements made in the sponsor notice is incorrect.
                                                                                                                                       (e) The device is not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the device 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 device does not comply with the essential principles.
                                                                                                                                       (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).
                                                                                                                                       (g) The device may be supplied to a person who is not the ultimate consumer of the device only if:
                                                                                                                                       (i) the supply is to the holder of a licence; or
                                                                                                                                       (ii) the supply is to 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 device; or
                                                                                                                                       (iii) the supply is to a person (a registered pharmacist) who is registered as a pharmacist under a law of a State or Territory providing for the registration of pharmacists; or
                                                                                                                                       (iv) the supply is to any other person who is authorised, under the law of the State or Territory in which that person deals with goods, to deal with one or more substances included in Schedule 4 to the current Poisons Standard, and the supply is in accordance with that authorisation.
                                                                                                                                       (h)