Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules March 2018
Therapeutic Goods Act 1989
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 September 2017 that was registered on 29 September 2017, and make the following Rules.
Dated 12 March 2018
(Signed by)
Delegate of the Minister for Health
These Rules are the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules March 2018.
These Rules commence the day after they are registered.
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
Item | Column 1 Product name | Column 2 Route of administration | Column 3 Indication | Column 4 Health practitioner |
1 | AlloDerm GBR RTM (human skin tissue matrix) | Intra-oral graft | Graft protection and containment | Dental practitioner |
2 | AlloDerm RTM (human skin tissue matrix) | Intra-oral graft | Root coverage Gingival augmentation | Dental practitioner |
3 | Amniotic Membrane | Ophthalmic | Ocular conditions | Medical practitioner |
4 | Grafton DBM Matrix (demineralised human bone tissue) | Intra-oral graft | Extraction socket grafting | Dental practitioner |
5 | MinerOss Cancellous (human bone allograft) | Intra-oral graft | Ridge and sinus augmentation | Dental practitioner |
6 | MinerOss Cortical (human bone allograft) | Intra-oral graft | Ridge and sinus augmentation | Dental practitioner |
7 | Puros Cancellous Particulate Allograft (human bone tissue) | Intra-oral graft | Ridge and sinus augmentation | Dental practitioner |
8 | Puros Cortical Particulate Allograft (human bone tissue) | Intra-oral graft | Ridge and sinus augmentation | Dental practitioner |
9 | Tutoplast Pericardium (sterilised human tissue allograft) | Topical | Soft tissue graft | Medical Practitioner |