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THERAPEUTIC GOODS (CHARGES) REGULATIONS 2018 - NOTES

- made under the Therapeutic Goods (Charges) Act 1989

made under the

Therapeutic Goods (Charges) Act 1989

Compilation No. 7

Compilation date: 1 July 2024

Includes amendments: F2024L00688

Registered: 1 July 2024

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Charges) Regulations 2018 that shows the text of the law as amended and in force on 1 July 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.

Editorial changes

For more information about any editorial changes made in this compilation, see 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Part 1--Preliminary

1 Name

3 Authority

5 Definitions

6 Classes of medical devices and biologicals

Part 2--Charges

7 Annual charges for biologics and some other goods

8 Annual charges for goods that are not biologics

9 Annual charges for provisionally registered medicines

Part 3--Application and transitional provisions

Division 1--Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

10 Transitional provision relating to the Therapeutic Goods Legislation Amendment (2019 Measures No.  1) Regulations 2019

Endnotes

Endnote 1--About the endnotes

Endnote 2--Abbreviation key

Endnote 3--Legislation history

Endnote 4--Amendment history

 

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.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

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

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)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub-Ch = Sub-Chapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3--Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Charges) Regulations 2018

14 June 2018 (F2018L00774)

s 5-9 and Sch 1: 1 July 2018 (s 2(1) item 2)
Remainder: 15 June 2018 (s 2(1) item 1)

 

Therapeutic Goods (Charges) Amendment Regulations 2019

25 Mar 2019 (F2019L00395)

1 July 2019 (s 2(1) item 1)

--

Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

18 Dec 2019 (F2019L01660)

Sch 1 (items 44, 45): 25 Nov 2021 (s 2(1) item 2)

--

as amended by

 

 

 

Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020

23 July 2020 (F2020L00946)

Sch 8 (item 1): 24 July 2020 (s 2(1) item 7)

--

Therapeutic Goods (Charges) Amendment (2020 Measures No. 1) Regulations 2020

16 June 2020 (F2020L00727)

1 July 2020 (s 2(1) item 1)

--

Therapeutic Goods (Charges) Amendment (2021 Measures No. 1) Regulations 2021

4 June 2021 (F2021L00694)

1 July 2021 (s 2(1) item 1)

--

Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022

11 Apr 2022 (F2022L00589)

1 July 2022 (s 2(1) item 1)

--

Therapeutic Goods (Charges) Amendment (2023 Measures No. 1) Regulations 2023

9 June 2023 (F2023L00758)

1 July 2023 (s 2(1) item 1)

--

Therapeutic Goods (Charges) Amendment (2024 Measures No. 1) Regulations 2024

17 June 2024 (F2024L00688)

1 July 2024 (s 2(1) item 1)

--

 

Endnote 4--Amendment history

 

Provision affected

How affected

Part 1

 

s 2.....................

rep LA s 48D

s 4.....................

rep LA s 48C

Part 2

 

s 7.....................

am F2019L00395; F2019L01660; F2020L00727; F2021L00694; F2022L00589; F2023L00758

 

ed C6

 

am F2024L00688

s 8.....................

am F2019L00395; F2020L00727; F2021L00694; F2022L00589; F2023L00758; F2024L00688

s 9.....................

am F2019L00395; F2020L00727; F2021L00694; F2022L00589; F2023L00758; F2024L00688

Part 3

 

Part 3...................

ad F2019L01660

Division 1

 

s 10....................

ad F2019L01660

Schedule 1................

rep LA s 48C

 

 


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