Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022 (Cth)

Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022

made under subsection 32CM(7A) of the

Therapeutic Goods Act 1989

Compilation No. 4

Compilation date: 21 August 2025

Includes amendments: F2025L00947

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022 that shows the text of the law as amended and in force on 21 August 2025 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register ( saving and transitional provisions

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. Any modifications affecting the law are accessible on the Register.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1. •
2. •
3. •
4. •

1

Name

This instrument is the Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022.

3

Authority

This instrument is made under subsection 32CM(7A) of the Therapeutic Goods Act 1989.

4

Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) biological;

(b) health practitioner;

(c) included in the Register;

(d) Register;

(e) sponsor;

(f) supply.

In this instrument:

Act means the Therapeutic Goods Act 1989.

SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 3.0, October 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 October 2024.

Note: The SAS Guidance is published at Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.

5Authorisation

Supply by a specified health practitioner

(1)

A health practitioner specified in column 5 of an item in the table in Schedule 1 is authorised to supply a biological to a patient of that practitioner where:

1. (a)

   the biological is specified in column 2 of that item; and

2. (b)

   the biological is to be administered by the route specified in column 3 of that item; and

3. (c)

   the supply is for the indication specified in column 4 of that item; and

4. (d)

   the conditions specified in subsection (2) are satisfied.

(2)

The health practitioner must:

1. (a)

   inform the patient, or a parent or guardian of the patient, that the biological is not included in the Register; and

2. (b)

   obtain informed consent from the patient, or a parent or guardian of the patient, in relation to, and before, the supply of the biological; and

3. (c)

   supply the biological in accordance with good medical practice or the relevant code of conduct for the health practitioner; and

4. (d)

   if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

5. (e)

   if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.

Supply to a patient of a specified health practitioner

(3)

A health practitioner is authorised to supply a biological to a patient of a health practitioner specified in column 5 of an item in the table in Schedule 1 (the treating practitioner) where:

1. (a)

   the biological is specified in column 2 of that item; and

2. (b)

   the supply is requested by the treating practitioner; and

3. (c)

   the biological is to be administered by the route specified in column 3 of that item; and

4. (d)

   the supply is for the indication specified in column 4 of that item; and

5. (e)

   the conditions specified in subsection (4) are satisfied.

(4)

The health practitioner supplying the biological must:

1. (a)

   if the health practitioner becomes aware that the patient has suffered an adverse event in relation to the biological—notify the Therapeutic Goods Administration and the sponsor of the biological about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

2. (b)

   if the health practitioner becomes aware of a defect in the biological—notify the Therapeutic Goods Administration and the sponsor of the biological in accordance with the reporting guidelines set out in the SAS Guidance.

Schedule 1—Biologicals authorised for supply

Note: See section 5.

Specified therapeutic goods
Column 1	Column 2	Column 3	Column 4	Column 5
Item	Biological	Route of administration	Indication	Health practitioner
3	Amniotic Membrane	ophthalmic	ocular conditions	medical practitioner
8	Ortho-ATI (tenocytes) cell suspension	intratendinous injection	treatment of chronic lateral epicondylitis or gluteal tendinopathy (> 6 months) with or without partial tendon tear, that is not responsive to conservative treatment	orthopaedic surgeon
11	Tutoplast Pericardium (sterilised human tissue allograft)	topical	soft tissue graft	medical practitioner

Endnotes

Endnote 1About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2Abbreviation key

ad = added or inserted	orig = original
am = amended	p = page(s)
amdt = amendment	para = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x	/sub‑subparagraph(s)
ch = Chapter(s)	pres = present
cl = clause(s)	prev = previous
cont. = continued	(prev…) = previously
def = definition(s)	pt = Part(s)
Dict = Dictionary	r = regulation(s)/Court rule(s)
disallowed = disallowed by Parliament	reloc = relocated
div = Division(s)	renum = renumbered
exp = expires/expired or ceases/ceased to have	rep = repealed
effect	rs = repealed and substituted
gaz = gazette	s = section(s)/subsection(s)
LA = Legislation Act 2003	/rule(s)/subrule(s)/order(s)/suborder(s)
LIA = Legislative Instruments Act 2003	sch = Schedule(s)
(md not incorp) = misdescribed amendment	SLI = Select Legislative Instrument
cannot be given effect	SR = Statutory Rules
mod = modified/modification	sub ch = Sub‑Chapter(s)
No. = Number(s)	sub div = Subdivision(s)
Ord = Ordinance	sub pt = Subpart(s)
underlining = whole or part not
commenced or to be commenced

Endnote 3Legislation history

Name	Registration	Commencement	Application, saving and transitional provisions
Therapeutic Goods (Biologicals—Authorised Supply) Rules 2022	16 Dec 2022 (F2022L01673)	17 Dec 2022	—
Therapeutic Goods (Medicines—Authorised Supply) Amendment (Vaping) Rules 2023	15 Dec 2023 (F2023L01683)	1 Jan 2024	—
Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024	6 Jun 2024 (F2024L00639)	5 Jun 2024	—
Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules (No. 2) 2024	16 Oct 2024 (F2024L01321)	17 Oct 2024	—
Therapeutic Goods (Authorised Supply) Amendment Rules 2025	20 Aug 2025 (F2025L00947)	Sch 1, Part 1: 21 Aug 2025 (s 2(1) item 2) Sch 1, Part 2: awaiting commencement (s 2(1) item 3)	—

Endnote 4Amendment history

Provision affected	How affected
s 2……………………………….	rep LA s 48D
s 4……………………………….	am F2023L01683; F2024L00639; F2024L01321; F2025L00947
s 5……………………………….	am F2025L00947
s 6……………………………….	rep LA s 48C
Schedule 1………………………	am F2025L00947
Schedule 2………………………	rep LA s 48C