Document ID: chunk:federal_register_of_legislation:F2024C01104:reg:5:p2
Version: federal_register_of_legislation:F2024C01104
Segment Type: reg
Provision Reference: reg 5 (pt 2/2)
Character Range: 6544–7277

item; and
 (f)  the supply is for the indication specified in column 5 of that item; and
 (g)  the conditions specified in subsection (4) are satisfied.
 (4) The health practitioner supplying the medicine must:
 (a)  if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine 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 medicine—notify the Therapeutic Goods Administration and the sponsor of the medicine in accordance with the reporting guidelines set out in the SAS Guidance.