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Therapeutic Goods (Charges) Act 1989

Authoritative Version
Act No. 22 of 1990 as amended, taking into account amendments up to Therapeutic Goods (Charges) Amendment Act 2018
An Act to impose an annual charge on the registration, listing and inclusion in the Register of therapeutic goods, on the licensing of manufacturers of therapeutic goods and on the making of conformity assessment body determinations
Administered by: Health
Registered 20 Mar 2018
Start Date 06 Mar 2018
Table of contents.

Commonwealth Coat of Arms of Australia

Therapeutic Goods (Charges) Act 1989

No. 22, 1990

Compilation No. 9

Compilation date:                              6 March 2018

Includes amendments up to:            Act No. 8, 2018

Registered:                                         20 March 2018

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Charges) Act 1989 that shows the text of the law as amended and in force on 6 March 2018 (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.

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 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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............ Short title............................................................................................. 1

2............ Commencement................................................................................... 1

3............ Incorporation....................................................................................... 1

4............ Charges............................................................................................... 2

5............ Regulations......................................................................................... 4

Endnotes                                                                                                                                      5

Endnote 1—About the endnotes                                                                              5

Endnote 2—Abbreviation key                                                                                  7

Endnote 3—Legislation history                                                                               8

Endnote 4—Amendment history                                                                             9

Endnote 5—Editorial changes                                                                               10


An Act to impose an annual charge on the registration, listing and inclusion in the Register of therapeutic goods, on the licensing of manufacturers of therapeutic goods and on the making of conformity assessment body determinations

 

 

1  Short title

                   This Act may be cited as the Therapeutic Goods (Charges) Act 1989.

2  Commencement

                   This Act commences on 1 July 1990.

3  Incorporation

             (1)  The Therapeutic Goods Act 1989 is incorporated, and is to be read as one, with this Act.

Note:          Subsection (1) applies the interpretation provisions of the Therapeutic Goods Act 1989 (such as subsection 3(8) of that Act, which says a reference to the registration of therapeutic goods includes a reference to the provisional registration of a medicine).

          (1A)  For the purposes of this Act, if a suspension of the registration or listing of therapeutic goods has effect under Part 3‑2 of the Therapeutic Goods Act 1989, the goods are taken to be included in the Register under that Part.

          (1B)  For the purposes of this Act, if a suspension of a biological from the Register has effect under Part 3‑2A of the Therapeutic Goods Act 1989, the biological is taken to be included in the Register under that Part.

             (2)  For the purposes of this Act, if a suspension of a kind of medical device, or any medical devices of a particular kind, has effect under Chapter 4 of the Therapeutic Goods Act 1989, that kind of medical device is taken to be included in the Register under that Chapter.

             (3)  For the purposes of this Act, if a suspension of a conformity assessment body determination has effect under regulations made for the purposes of Part 4‑4A of the Therapeutic Goods Act 1989, the determination is taken to be in force for the period of the suspension.

4  Charges

             (1)  Annual charges of such amounts as are prescribed are payable in respect of the registration or listing of therapeutic goods, other than grouped therapeutic goods, that is in force at any time during a financial year.

Note:          The reference to registration of therapeutic goods includes a reference to the provisional registration of a medicine (see subsection 3(8) of the Therapeutic Goods Act 1989 as applied by subsection 3(1) of this Act).

          (1A)  If the registration or listing of one or more grouped therapeutic goods, being goods covered by a single registration or listing number, is in force at any time during a financial year, an annual charge of such amount as is prescribed is payable in respect of all of the registrations or listings concerned.

       (1AA)  An annual charge of such amount as is prescribed is payable in respect of the inclusion of a biological in the Register under Part 3‑2A of the Therapeutic Goods Act that has effect at any time during a financial year.

          (1B)  Annual charges of such amounts as are prescribed are payable in respect of the inclusion of kinds of medical devices in the Register under Chapter 4 of the Therapeutic Goods Act that has effect at any time during a financial year.

             (2)  An annual charge of such amount as is prescribed is payable in respect of a licence that is in force at any time during a financial year.

          (2A)  An annual charge of such amount as is prescribed is payable in respect of a conformity assessment body determination that is in force at any time during a financial year.

Corresponding State laws

             (3)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.

          (3A)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as provisionally registered goods, this section has effect as if the goods had been registered under Part 3‑2 of that Act.

             (4)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for goods known as listed goods, this section has effect as if the goods had been listed under Part 3‑2 of that Act.

          (4A)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, a biological is included in the part of the Register for biologicals included under Part 3‑2A, this section has effect as if the biological had been included in the Register under Part 3‑2A of that Act.

             (5)  If, because of the operation of section 6AAE of the Therapeutic Goods Act, goods are included in the part of the Register for medical devices included under Chapter 4, this section has effect as if the goods had been included in the Register under Chapter 4 of that Act.

             (6)  If:

                     (a)  because of the operation of section 6AAA, 6AAB or 6AAC of the Therapeutic Goods Act, the Secretary issues a licence; and

                     (b)  the licence is issued for the purposes of provisions of a corresponding State law that correspond to Part 3‑3 of the Therapeutic Goods Act;

this section has effect as if the licence had been issued under Part 3‑3 of that Act.

Definitions

             (7)  In this section:

amount includes a nil amount.

Therapeutic Goods Act means the Therapeutic Goods Act 1989.

5  Regulations

             (1)  The Governor‑General may make regulations, not inconsistent with this Act, prescribing the amounts of charges.

             (2)  The regulations may prescribe different charges in relation to:

                     (a)  different classes of goods (including medical devices); or

                     (b)  in the case of annual licensing charges—different steps in the manufacture of goods; or

                     (c)  conformity assessment body determinations of different kinds.


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 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)

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

 

Act

Number and year

Assent

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Charges) Act 1989

22, 1990

17 Jan 1990

1 July 1990 (s 2)

 

Therapeutic Goods (Charges) Amendment Act 1991

85, 1991

26 June 1991

26 June 1991 (s 2)

s 4, 5

Therapeutic Goods (Charges) Amendment Act 1993

62, 1993

3 Nov 1993

3 Nov 1993 (s 2)

Therapeutic Goods (Charges) Amendment Act 2002

25, 2002

4 Apr 2002

Sch 1: 4 Oct 2002 (s 2(1) item 2)

Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008

96, 2008

3 Oct 2008

Sch 1 (items 4–6): 1 Jan 2009 (s 2(1) item 2)

Sch 1 (item 6)

Therapeutic Goods (Charges) Amendment Act 2010

53, 2010

31 May 2010

Sch 1: 31 May 2011 (s 2(1) item 2)

Therapeutic Goods (Charges) Amendment Act 2018

8, 2018

5 Mar 2018

Sch 1: 6 Mar 2018 (s 2(1) item 2)

Sch 1 (item 8)

 

Endnote 4—Amendment history

 

Provision affected

How affected

Title.....................................

am No 25, 2002; No 8, 2018

 

ed C9

s 3........................................

am No 25, 2002; No 53, 2010; No 8, 2018

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

am No 85, 1991; No 62, 1993; No 25, 2002; No 96, 2008; No 53, 2010; No 8, 2018

s 5........................................

am No 25, 2002; No 96, 2008; No 8, 2018

 

Endnote 5—Editorial changes

In preparing this compilation for registration, the following kinds of editorial change(s) were made under the Legislation Act 2003.

 

Long title

 

Kind of editorial change

 

Change to punctuation

 

Details of editorial change

 

Schedule 1 item 1 of the Therapeutic Goods (Charges) Amendment Act 2018 provides as follows:

1  Title

Omit “and on the licensing of manufacturers of therapeutic goods”, substitute “, on the licensing of manufacturers of therapeutic goods and on the making of conformity assessment body determinations”.

 

This action leaves two commas before the phrase “on the licensing”.

 

This compilation was editorially changed to omit the redundant comma.