5Authorisation

5 Authorisation

Supply by a medical practitioner (1) A health practitioner who is a medical practitioner is authorised to supply a medicine to a patient of that practitioner where: (a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and (c) the medicine is in the dosage form specified in column 3 of that item; and (d) the medicine 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 conditions specified in subsection (2) are satisfied. (2) The medical practitioner must: (a) inform the patient, or a parent or guardian of the patient, that the medicine is not a listed good or registered good; 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 medicine; and (c) supply the medicine in accordance with good medical practice; and (d) if the medical 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 (e) if the medical 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. Supply to a patient of a medical practitioner (3) A health practitioner is authorised to supply a medicine to a patient of a medical practitioner (the treating practitioner) where: (a) the medicine contains an active ingredient specified in column 2 of an item in the table in Schedule 1 and does not contain any other active ingredient; and (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and (c) the supply is requested by the treating practitioner; and (d) the medicine is in the dosage form specified in column 3 of that item; and (e) the medicine is to be administered by the route specified in column 4 of that 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.