Therapeutic Goods (Exempt Monographs) Determination 2021 made under section 3C of the Therapeutic Goods Act 1989 Compilation No. 3 Compilation date: 1 October 2024 Includes amendments: F2024L01232 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 1 October 2024 (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 Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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 Schedule 1—Exempt 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: (c) standard; (d) therapeutic goods; (e) United States Pharmacopeia-National Formulary. In this instrument: Act means the Therapeutic Goods Act 1989. 5 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 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 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 01 Oct 2021 — (F2021L00594) Therapeutic Goods (Exempt Monographs) Amendment Determination 2022 28 Mar 2022 31 Mar 2022 — (F2022L00401) Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Amendment (Vaping) Order 2023 15 Dec 2023 01 Jan 2024 — (F2023L01680) Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024 30 Sep 2024 01 Oct 2024 — (F2024L01232) Endnote 4—Amendment history Provision affected How affected s 2………………………………. rep LA s 48D s 4………………………………. am F2023L01680; F2024L01232 Schedule 1……………………… am F2022L00401; F2023L01680; F2024L01232