Federal Register of Legislation - Australian Government

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Rules/Other as made
These rules authorise the supply of specified biologicals by specified classes of health practitioners.
Administered by: Health
Made 28 Jun 2017
Registered 03 Jul 2017
Tabled HR 08 Aug 2017
Tabled Senate 08 Aug 2017
Date of repeal 30 Sep 2017
Repealed by Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules September 2017

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)

 

LARRY KELLY

Delegate of the Minister for Health


1              Name

                These Rules are the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017.

2              Commencement

                These Rules commence on 3 July 2017.

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, 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
Active ingredient

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