Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Latest version

View as made version

F2024C01104 (C04)

17 October 2024

Table of contents

1 Name
3 Authority
4 Definitions
5 Authorisation
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.
Schedule 1—Medicines authorised for supply
Schedule 1A—Therapeutic vaping goods

Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 Citation change

Legislation text

Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022