Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:12b
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 12B
Character Range: 185528–187427

12B  Exemptions for certain uses—medicines
 (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.
 (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:
 (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and
 (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.
 (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:
 (a) the medicine contains an active ingredient specified in column 2 of an item in the following table 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.

Specified therapeutic goods
Column 1                     Column 2                                                               Column 3                  Column 4                 Column 5
Item                         Active ingredient                                                      Dosage form               Route of administration  Indication