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Determinations/Health as amended, taking into account amendments up to Therapeutic Goods (Exempt Monographs) Amendment Determination 2022
Administered by: Health and Aged Care
Registered 04 Apr 2022
Start Date 31 Mar 2022
Table of contents.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Endnotes                                                                                                                        3

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 www.legislation.gov.au.

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