Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:5a_15:p5
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 5A cl 15 (pt 5/6)
Character Range: 609089–616570

the goods may be supplied to the ultimate consumer of the goods only if:
                                                                                                                                                                                                                                                                                                                                                                                                  (i) the goods are supplied as a finished product; and
                                                                                                                                                                                                                                                                                                                                                                                                  (ii) the supply is by a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; and
                                                                                                                                                                                                                                                                                                                                                                                                  (iii) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—the supply is in accordance with an approval or authority under section 19 of the Act; and
                                                                                                                                                                                                                                                                                                                                                                                                  (iv) if the supply is by a person authorised as described in subparagraph (ii), the supply is in accordance with that authorisation; and
                                                                                                                                                                                                                                                                                                                                                                                                  (j) the sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                  (i) keep records relating to the source and supply of the goods; and
                                                                                                                                                                                                                                                                                                                                                                                                  (ii) if requested by the Secretary, give a copy of 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); and
                                                                                                                                                                                                                                                                                                                                                                                                  (iii) if the Secretary requests information about the supply of the goods during a specified period—give the information 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) and in a form approved in writing by the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                  (k) the sponsor must provide information of a kind mentioned in subsection 29A(2) or 29AA(2) of the Act relating to the goods 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 goods, 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 goods, 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