Document ID: chunk:federal_register_of_legislation:F2024C01101:reg:5
Version: federal_register_of_legislation:F2024C01101
Segment Type: reg
Provision Reference: reg 5
Character Range: 3179–5877

5  Authorisation

Supply by a specified health practitioner
 (1) A health practitioner specified in column 5 of an item in the table in Schedule 1 is authorised to supply a biological to a patient of that practitioner where:
 (a) the biological is specified in column 2 of that item; and
 (b) the biological is to be administered by the route specified in column 3 of that item; and
 (c) the supply is for the indication specified in column 4 of that item; and
 (d) the conditions specified in subsection (2) are satisfied.
 (2) The health practitioner must:
 (a) inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register; and
 (b) obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the biological; and
 (c) supply the biological in accordance with good medical practice or the relevant code of conduct for the health practitioner; and
 (d) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and
 (e) if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.

Supply to a patient of a specified health practitioner
 (3) A health practitioner is authorised to supply a biological to a patient of a health practitioner specified in column 5 of an item in the table in Schedule 1 (the treating practitioner) where:
 (a) the biological is specified in column 2 of that item; and
 (b) the supply is requested by the treating practitioner; and
 (c) the biological is to be administered by the route specified in column 3 of that item; and
 (d) the supply is for the indication specified in column 4 of that item; and
 (e) the conditions specified in subsection (4) are satisfied.
 (4) The health practitioner supplying the biological must:
 (a) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological 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 biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.