I, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 32CM(7A) of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules March 2018 that was registered on 14 March 2018, and make the following Rules.

Dated 27 March 2018

(Signed by)

1 Name

  These Rules are the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules April 2018.

2 Commencement

  These Rules commence on 1 April 2018.

3 Authority

  These Rules are made under subsection 32CM(7A) of the Therapeutic Goods Act 1989.

4 Authorisation to supply biologicals

 (1) A health practitioner of a class specified in column 4 in an item in table 1 is authorised to supply a biological specified in column 1 in the item to a person if:

(a) the person is a patient of the health practitioner; and

(b) the biological is to be administered through the route of administration specified in column 2 in the item; and

(c) the supply is for an indication specified in column 3 in the item; and

(d) the following conditions are satisfied:

(i) the health practitioner must inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register;

(ii) the health practitioner must ensure that the biological is supplied only after receiving informed consent from the patient, or a parent or guardian of the patient;

(iii) the health practitioner must ensure that the biological is supplied in accordance with good medical practice;

(iv) if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the biological, about the adverse event, in accordance with subsection (3);

(v) if the health practitioner becomes aware of any defect in the biological, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the biological, about the defect, in accordance with subsection (3).

 (2) A health practitioner is authorised to supply a biological specified in column 1 in an item in table 1 to a person if:

(a) the person is a patient of another health practitioner (the treating practitioner); and

(b) the treating practitioner is a health practitioner of a class specified in column 4 in the item; and

(c) the supply is requested by the treating practitioner; and

(d) the biological is to be administered through the route of administration specified in column 2 in the item; and

(e) the supply is for an indication specified in column 3 in the item; and

(f) the following conditions are satisfied:

(i) if the health practitioner supplying the biological becomes aware that the patient has suffered an adverse event in relation to the biological, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the biological, about the adverse event;

(ii) if the health practitioner supplying the biological becomes aware of any defect in the biological, the health practitioner must notify the Therapeutic Goods Administration, and the sponsor of the biological, about the defect.

 (3)    For the purposes of subparagraphs (1)(d)(iv) and (v) and (2)(f)(i) and (ii), notification must be in accordance with the reporting guidelines set out in the document titled Special Access Scheme Guidance for health practitioners and sponsors, version 1.1, published by the Therapeutic Goods Administration in September 2017.

Table 1: Authorised supply of biologicals