Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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.
(2) The class of recipients prescribed for the purposes of paragraph 19 (6) (b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.
(3) For the purposes of subsection 19 (7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19 (5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.
(4) For the purposes of subsection 19 (7) of the Act, the prescribed circumstances in which a therapeutic device, or a class of therapeutic devices, may be supplied in accordance with an authority under subsection 19 (5) of the Act are:
(a) that, in each case, the medical practitioner authorised under subsection 19 (5) of the Act:
(i) is a specialist engaged in clinical practice at a hospital; and
(ii) is endorsed by the relevant ethics committee of the hospital; and
(b) that the authority states the particular therapeutic intervention, or class of therapeutic intervention, for which the medical practitioner may supply the therapeutic device or class of therapeutic devices.