Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:12c
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 12C
Character Range: 221833–223784

12C  Exemptions for health practitioners—biologicals
 (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.
 (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:
 (a) has demonstrated that, for the proposed supply of the biological, 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 biological, to supply the biological.
 (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.
 (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.
 (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:
 (a) the person's initials, date of birth and gender;
 (b) each medical condition in relation to which the biological was supplied;
 (c) each indication of the biological in relation to which the biological was supplied;
 (d) a description of the biological, including the following:
 (i) the product name of the biological;
 (ii) each active ingredient of the biological;
 (iii) the route of administration of the biological;
 (e) the practitioner's name, AHPRA number and contact details;
 (f) the health profession in which the practitioner is registered or licensed to practise;
 (g) the address of the practitioner's principal place of practice.