Therapeutic Goods (Exempt Monographs) Determination 2021 (Cth)
Therapeutic Goods (Exempt Monographs) Determination 2021
made under section 3C of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 31 March 2022
Includes amendments up to: F2022L00401
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 31 March 2022 (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 Legislation Register ( 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 series page on the Legislation 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 series page on the Legislation 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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........................................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Definitions................................................................................................................................ 1
5 Exemption................................................................................................................................ 1
Schedule 1—Exempt monographs 2
Endnotes3
Endnote 1—About the endnotes 3
Endnote 2—Abbreviation key 4
Endnote 3—Legislation history 5
Endnote 4—Amendment history 6
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) standard;
(d) therapeutic goods;
(e) United States Pharmacopeia-National Formulary.
In this instrument:
Act means the Therapeutic Goods Act 1989.
nicotine vaping product has the same meaning as in TGO 110.
TGO 110 means the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021.
Note: TGO 110 is a legislative instrument published on the Federal Register of Legislation at Exemption
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.
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 1 all monographs applicable to the therapeutic goods all of the following:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
(c) United States Pharmacopoeia-National Formulary
a nicotine vaping product to which TGO 110 applies 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 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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted o = order(s) am = amended Ord = Ordinance amdt = amendment orig = original c = clause(s) par = paragraph(s)/subparagraph(s) C[x] = Compilation No. x /sub‑subparagraph(s) Ch = Chapter(s) pres = present def = definition(s) prev = previous Dict = Dictionary (prev…) = previously disallowed = disallowed by Parliament Pt = Part(s) Div = Division(s) r = regulation(s)/rule(s) exp = expires/expired or ceases/ceased to have reloc = relocated effect renum = renumbered F = Federal Register of Legislation rep = repealed gaz = gazette rs = repealed and substituted LA = Legislation Act 2003 s = section(s)/subsection(s) LIA = Legislative Instruments Act 2003 Sch = Schedule(s) (md) = misdescribed amendment can be given Sdiv = Subdivision(s) effect 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 commenced or to be commenced 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 ¾ Therapeutic Goods (Exempt Monographs) Amendment Determination 2022 28 Mar 2022
(F2022L00401)31 Mar 2022 ¾ Endnote 4—Amendment history
Provision affected How affected s 2........................................ rep LA s 48D Sch 1.................................... am F2022L00401
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