Document ID: chunk:federal_register_of_legislation:F2023L01683:clause:1_5:p2
Version: federal_register_of_legislation:F2023L01683
Segment Type: clause
Provision Reference: sch 1 cl 5 (pt 2/2)
Character Range: 5990–7033

treating practitioner; and
 (c) the therapeutic good is in the dosage form specified in column 3 of that item; and
 (d) the therapeutic good is to be administered by the route specified in column 4 of that item; and
 (e) the supply is for the indication specified in column 5 of that item; and
 (f) the supply is to a patient who is 16 years of age or over; and
 (g) the conditions specified in subsection (4) are satisfied.
 (4) The health practitioner supplying the therapeutic good must:
 (a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and
 (b) if the health practitioner becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.