Document ID: chunk:federal_register_of_legislation:F2024C01104:reg:5a:p1
Version: federal_register_of_legislation:F2024C01104
Segment Type: reg
Provision Reference: reg 5A (pt 1/3)
Character Range: 7279–9914

5A  Authorisation—therapeutic vaping goods

Supply by a medical practitioner or nurse practitioner
 (1) A health practitioner who is a medical practitioner or a nurse practitioner is authorised to supply a therapeutic good to a patient of that practitioner where:
 (a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and
 (b) the therapeutic good is in the dosage form specified in column 3 of that item; and
 (c) the therapeutic good is to be administered by the route specified in column 4 of that item; and
 (d) the supply is for the indication specified in column 5 of that item; and
 (e) the supply is to a patient who is 16 years of age or over; and
 (f) the conditions specified in subsection (2) are satisfied.
 (2) The medical practitioner or nurse practitioner must:
 (a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and
 (b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and
 (c) supply the therapeutic good in accordance with good medical practice or good nursing practice (as the case requires); and
 (d) if the medical practitioner or nurse 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
 (e) if the medical practitioner or nurse 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.

Supply by a pharmacist—with prescription
 (3) A pharmacist is authorised to supply a therapeutic good to a patient of a medical practitioner or a nurse practitioner (the treating practitioner) where:
 (a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and
 (b) the supply is requested by the 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