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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Schedule 2—Exempt parts of monographs

Note: See section 6.

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

Endnote 3—Legislation history

Endnote 4—Amendment history