Document ID: chunk:federal_register_of_legislation:F2023L01667:clause:1_15:p2
Version: federal_register_of_legislation:F2023L01667
Segment Type: clause
Provision Reference: sch 1 cl 15 (pt 2/3)
Character Range: 14234–21058

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) 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 goods; 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; and
                                                                                                                                                                                                                                                               (i) 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 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) 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 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
                                                                                                                                                                                                                                                               (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