Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017
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, make the following Rules.
Dated 28 June 2017
(signed by)
Delegate of the Minister for Health
These Rules are the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017.
These Rules commence on 3 July 2017.
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, in accordance with subsection (3);
(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, in accordance with subsection (3).
(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 1.0, published by the Therapeutic Goods Administration in June 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 | MinerOss Cortical & Cancellous Chips (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
2 | MinerOss Block Allograft (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
3 | MinerOss Cancellous (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
4 | MinerOss Cortical (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
5 | MinerOss X Cancellous (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
6 | MinerOss X Cortical (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
7 | MinerOss X Syringe (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
8 | MinerOss X Collagen (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
9 | MinerOss XP Cancellous (anorganic bovine bone) | Oral-maxillofacial | Calcium source for particulate bone grafts | Dental practitioner |
10 | AlloDerm GBR RTM (human skin tissue matrix) | Oral-maxillofacial | Graft protection and containment | Medical Practitioner Dental practitioner |
11 | AlloDerm GBR RTM (human skin tissue matrix) | Oral-maxillofacial | Flap extender to achieve primary closure | Medical Practitioner Dental practitioner |
12 | AlloDerm RTM (human skin tissue matrix) | Oral-maxillofacial | Root coverage | Dental Practitioner |
13 | AlloDerm RTM (human skin tissue matrix) | Oral-maxillofacial | Gingival augmentation | Dental practitioner |
14 | AlloDerm RTM (human skin tissue matrix) | Oral-maxillofacial | Soft tissue ridge augmentation | Dental practitioner |
15 | AlloDerm RTM (human skin tissue matrix) | Oral-maxillofacial | Soft tissue augmentation around implants | Dental practitioner |
16 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Extraction socket grafting | Dental practitioner |
17 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Ridge and sinus augmentation | Dental practitioner |
18 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Bone augmentation around implants | Dental practitioner |
19 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Bony defects | Dental practitioner |
20 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Composite grafting with appropriate MinerOss® products only | Dental practitioner |
21 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Filling of periodontal defects | Dental practitioner |
22 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Extraction socket grafting | Dental practitioner |
23 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Ridge and sinus augmentation | Dental practitioner |
24 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Bone augmentation around implants | Dental practitioner |
25 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Bony defects | Dental practitioner |
26 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Composite grafting with MinerOss® | Dental practitioner |
27 | Grafton DBM Matrix (demineralized human bone tissue) | Oral-maxillofacial | Filling of periodontal defects | Dental practitioner |
28 | Tutoplast (sterilized human tissue allograft), | Ophthalmic | Ocular conditions | Medical Practitioner |
29 | Tutoplast (sterilized human tissue allograft), | Topical | Soft tissue graft | Medical Practitioner |
30 | Amniotic Membrane | Ophthalmic | Ophthalmic use | Medical practitioner |
31 | Puros Cortico-Cancellous Particulate Allograft (human bone tissue) | Oral-maxillofacial | For hard and soft tissue augmentation procedures | Medical Practitioner Dental practitioner |
32 | Puros Cancellous Particulate Allograft (human bone tissue) | Oral-maxillofacial | For hard and soft tissue augmentation procedures | Medical Practitioner Dental practitioner |
33 | Puros Cortical Particulate Allograft (human bone tissue) | Oral-maxillofacial | For hard and soft tissue augmentation procedures | Medical Practitioner Dental practitioner |