Document ID: chunk:federal_register_of_legislation:F2023L01667:clause:2_9:p2
Version: federal_register_of_legislation:F2023L01667
Segment Type: clause
Provision Reference: sch 2 cl 9 (pt 2/3)
Character Range: 34924–39140

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) The device may be supplied to the ultimate consumer of the device only if:
                                                                                                                                       (i) the device is supplied as a finished product; and
                                                                                                                                       (ii) the supply is by a registered pharmacist or by another person who is authorised, under the law of a State or Territory, to supply one or more substances included in Schedule 4 to the current Poisons Standard to an ultimate consumer; and
                                                                                                                                       (iii) if the supply is by a person authorised as described in subparagraph (ii), the supply is in accordance with that authorisation.
                                                                                                                                       (i) The sponsor must:
                                                                                                                                       (i) keep records relating to the source and supply of the device; and
                                                                                                                                       (ii) if requested by the Secretary, give the records to the Secretary 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).
                                                                                                                                       (j) The sponsor must provide information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act relating to the device to the Secretary within the following periods:
                                                                                                                                       (i) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the sponsor becomes aware of the event or occurrence;
                                                                                                                                       (ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—10 days after the sponsor becomes aware of the event or occurrence;
                                                                                                                                       (iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—30 days after the sponsor becomes aware of the event or occurrence;
                                                                                                                                       (iv) in any other case—60 days after the sponsor becomes aware of the information.
2.18  Medical device imported into Australia, if the medical device is a component or article imported for use in the manufacture of:  (a) The sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that the device is for use in the manufacture, in accordance with the requirements of the Act, of a therapeutic vaping device or a therapeutic vaping device accessory by a manufacturer that holds all relevant licences or approvals (however described) required under the law of the State or Territory in which