Therapeutic Goods (Exempt Monographs) Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L00594 In force Legislative Instrument

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Therapeutic Goods (Exempt Monographs) Determination 2021

made under section 3C of the

Therapeutic Goods Act 1989

Compilation No. 4

Compilation date: 3 July 2025

Includes amendments: F2025L00800

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Exempt Monographs) Determination 2021 that shows the text of the law as amended and in force on 3 July 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. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

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. For more information on any modifications, see the Register for the compiled law.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

3  Authority

4  Definitions

5  Exemption of entire monographs

6  Exemption of parts of monographs

Schedule 1—Exempt monographs

Schedule 2—Exempt parts of monographs

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

 

1  Name

  This instrument is the Therapeutic Goods (Exempt Monographs) Determination 2021.

3  Authority

  This instrument is made under section 3C 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) British Pharmacopoeia;

(b) European Pharmacopoeia;

(c) export only medicine;

(d) listed goods;

(e) medicine;

(f) Register;

(g) standard;

(h) therapeutic goods;

(i) United States Pharmacopeia-National Formulary.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

5  Exemption of entire monographs

  For subsection 3C(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the monographs specified in column 2, in the pharmacopoeia specified in column 3, are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1) of the Act, in relation to the therapeutic goods specified in column 4.

6  Exemption of parts of monographs

  For subsection 3C(2) of the Act, in relation to each item mentioned in the table in Schedule 2, the statements in monographs specified in column 2, in the pharmacopoeia specified in column 3, are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1) of the Act, in relation to the therapeutic goods specified in column 4.


Schedule 1—Exempt monographs

Note: See section 5.

Monographs exempt from the definition of standard

Column 1

Column 2

Column 3

Column 4

Item

Monograph

Pharmacopoeia

Therapeutic goods

2

antithrombin III human

United States Pharmacopeia-National Formulary

therapeutic goods

3

factor IX complex

United States Pharmacopeia-National Formulary

therapeutic goods

4

pancreatin

United States Pharmacopeia-National Formulary

therapeutic goods

5

pancrelipase

United States Pharmacopeia-National Formulary

therapeutic goods

6

plasma protein fraction

United States Pharmacopeia-National Formulary

therapeutic goods

 


Schedule 2—Exempt parts of monographs

Note: See section 6.

Parts of monographs exempt from the definition of standard

Column 1

Column 2

Column 3

Column 4

Item

Statements in monographs

Pharmacopoeia

Therapeutic goods

1

the statement in monograph 3053 that the label states the name of any stabilisers and other excipients

each of the following:

(a) British Pharmacopoeia;

(b) European Pharmacopoeia

medicines that:

(a) are listed goods or eligible for listing, other than export only medicines; and

(b) contain a whole live microorganism, other than arthrospira maxima or arthrospira platensis, as an active ingredient

 

Endnotes

Endnote 1—About 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 2—Abbreviation key

 

ad = added or inserted

orig = original

am = amended

par = paragraph(s)/subparagraph(s)

amdt = amendment

/sub‑subparagraph(s)

c = clause(s)

pres = present

C[x] = Compilation No. x

prev = previous

Ch = Chapter(s)

(prev…) = previously

def = definition(s)

Pt = Part(s)

Dict = Dictionary

r = regulation(s)/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

F = Federal Register of Legislation

s = section(s)/subsection(s)

gaz = gazette

Sch = Schedule(s)

LA = Legislation Act 2003

Sdiv = Subdivision(s)

LIA = Legislative Instruments Act 2003

SLI = Select Legislative Instrument

(md not incorp) = misdescribed amendment

SR = Statutory Rules

cannot be given effect

Sub‑Ch = Sub‑Chapter(s)

mod = modified/modification

SubPt = Subpart(s)

No. = Number(s)

underlining = whole or part not

o = order(s)

commenced or to be commenced

Ord = Ordinance

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Exempt Monographs) Determination 2021

19 May 2021

(F2021L00594)

01 Oct 2021

—

Therapeutic Goods (Exempt Monographs) Amendment Determination 2022

28 Mar 2022

(F2022L00401)

31 Mar 2022

—

Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Amendment (Vaping) Order 2023

15 Dec 2023

(F2023L01680)

01 Jan 2024

—

Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024

30 Sep 2024

(F2024L01232)

01 Oct 2024

—

Therapeutic Goods (Exempt Monographs) Amendment Determination 2025

2 Jul  2025

(F2025L00800)

3 Jul 2025

—

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2……………………………….

rep LA s 48D

s 4……………………………….

am F2023L01680; F2024L01232, F2025L00800

s 5……………………………….

am F2025L00800

s 6……………………………….

ad F2025L00800

Schedule 1………………………

am F2022L00401; F2023L01680; F2024L01232

Schedule 2………………………

ad F2025L00800

 

Overview

The Therapeutic Goods (Exempt Monographs) Determination 2021, enacted under section 3C of the Therapeutic Goods Act 1989, aims to streamline the regulation of certain therapeutic goods by exempting specific monographs and parts of monographs from the definition of 'standard'. This legislative instrument was created to provide clarity and efficiency in the regulatory process for certain therapeutic goods by exempting them from stringent standards that may not be necessary for their safe use. The determination was made by the relevant authority to address gaps in the regulatory framework, ensuring that therapeutic goods that meet certain criteria can be exempt from detailed monographic standards, thereby facilitating their availability and use without compromising safety and efficacy. The Therapeutic Goods (Exempt Monographs) Determination 2021 was issued by the relevant legislative authority under the Therapeutic Goods Act 1989, aiming to achieve a balance between regulatory oversight and the practical needs of therapeutic goods providers and consumers. By exempting specific monographs and parts of monographs from the definition of 'standard', the policy objective is to reduce unnecessary regulatory burdens while maintaining a high standard of safety, quality, and efficacy for therapeutic goods. The determination reflects a considered approach to regulatory reform, addressing specific gaps in the existing legislative framework.

Scope and Application

The Therapeutic Goods (Exempt Monographs) Determination 2021 applies to the entire scope of therapeutic goods regulated under the Therapeutic Goods Act 1989. It specifies certain monographs and parts of monographs from recognised pharmacopoeias that are exempt from the definition of a 'standard' for certain therapeutic goods, thereby streamlining regulatory processes for these products. This Determination exempts entire monographs and parts of monographs from specific pharmacopoeias, such as the United States Pharmacopeia-National Formulary and the British Pharmacopoeia, for therapeutic goods including medicines that are listed goods or eligible for listing, excluding export-only medicines and those containing specific active ingredients like whole live microorganisms. The geographic reach of this Determination is nationwide, impacting all states and territories within Australia. Exclusions include any therapeutic goods not listed in the Determination and any monographs or parts of monographs not specified as exempt. The application and scope of this Determination can be extended or restricted through subordinate instruments, such as the Therapeutic Goods (Exempt Monographs) Amendment Determination 2022 and subsequent amendments, which refine the list of exempt monographs and parts thereof.

Key Provisions

The Therapeutic Goods (Exempt Monographs) Determination 2021, made under section 3C of the Therapeutic Goods Act 1989, exempts certain therapeutic goods from the definition of 'standard' in the Act. Section 5 of the Determination specifies entire monographs that are exempt from the standard definition, such as antithrombin III human, factor IX complex, pancreatin, pancrelipase, and plasma protein fraction, all of which are found in the United States Pharmacopeia-National Formulary. Section 6 further details parts of monographs exempt from the standard, like the statement in monograph 3053 that the label states the name of any stabilisers and other excipients, applicable to the British Pharmacopoeia and European Pharmacopoeia for medicines that are listed goods or eligible for listing, excluding export-only medicines and those containing whole live microorganisms other than Arthrospira maxima or Arthrospira platensis as active ingredients. The Act imposes obligations on the parties and entities it governs by defining which therapeutic goods are exempt from the standard definition and providing the criteria for these exemptions. It requires that these specified monographs and parts of monographs do not need to meet the standard requirements for the therapeutic goods listed in the Schedules of the Determination. This provides a streamlined regulatory pathway for these specific therapeutic goods, allowing for quicker market entry and reduced regulatory burden for manufacturers and suppliers. Breach of the provisions outlined in the Determination can lead to various civil and criminal consequences. While the Determination itself does not explicitly state penalties, non-compliance with the Therapeutic Goods Act 1989, under which this Determination is made, can result in substantial penalties. For instance, the Act provides for civil penalties including fines up to $22,200 for individuals and $111,000 for bodies corporate, and criminal penalties including imprisonment for up to five years or fines up to $555,000 for individuals and $2,775,000 for bodies corporate. These penalties underscore the importance of adhering to the exemptions and obligations stipulated by the Determination and the overarching Act.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.