Federal Register of Legislation - Australian Government

Primary content

SR 1990 No. 395 Regulations as amended, taking into account amendments up to Therapeutic Goods (Charges) Amendment (2016 Measures No. 1) Regulation 2016
Principal Regulations
Administered by: Health
Registered 15 Jul 2016
Start Date 01 Jul 2016
End Date 30 Jun 2017
Date of repeal 01 Jul 2018
Repealed by Therapeutic Goods (Charges) Regulations 2018
Table of contents.

Therapeutic Goods (Charges) Regulations 1990

Statutory Rules No. 395, 1990

made under the

Therapeutic Goods (Charges) Act 1989

Compilation No. 30

Compilation date:                              1 July 2016

Includes amendments up to:            F2016L00668

Registered:                                         15 July 2016

 

 

 

 

 

 

 

 

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Charges) Regulations 1990 that shows the text of the law as amended and in force on 1 July 2016 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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............ Name of regulations............................................................................ 1

2............ Interpretation....................................................................................... 1

3............ Annual charges................................................................................... 1

4............ Annual charges for goods that are not biologics................................. 4

Endnotes                                                                                                                                      8

Endnote 1—About the endnotes                                                                              8

Endnote 2—Abbreviation key                                                                                  9

Endnote 3—Legislation history                                                                             10

Endnote 4—Amendment history                                                                           12

 


1  Name of regulations

                   These Regulations are the Therapeutic Goods (Charges) Regulations 1990.

2  Interpretation

             (1)  In these Regulations, unless the contrary intention appears:

biologic, in relation to therapeutic goods, means goods in which the active ingredient is a biological substance.

biological substance means a substance of biological origin that:

                     (a)  in many cases, is chemically complex and with a molecular weight of more than 1 000; and

                     (b)  is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.

Example:    Hormones, enzymes and related substances are biological substances. Herbal substances and antibiotics are not biological substances.

Class 1 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 2 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 3 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Class 4 biological has the same meaning as in the Therapeutic Goods Regulations 1990.

Poisons Standard has the same meaning as current Poisons Standard in Part 5B of the Therapeutic Goods Act 1989.

the Act means the Therapeutic Goods (Charges) Act 1989.

             (2)  In these Regulations, a reference to a medical device of a particular class is a reference to a medical device classified as that class under Division 3.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.

3  Annual charges

             (1)  For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods are:

                     (a)  for goods whose registration is in force at any time during the financial year to which the charge relates and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                              (i)  if the goods are a medicine—$1 410; and

                             (ii)  if the goods are a medical device—$2 765; and

                            (iii)  in any other case—$1 580; and

                     (b)  for goods:

                              (i)  whose registration is in force at any time during the financial year to which the charge relates; and

                             (ii)  that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and

                            (iii)  that are a biologic;

                            $6 875; and

                     (c)  for goods (other than goods produced for export) the listing of which is in force at any time during the financial year to which the charge relates:

                              (i)  if the goods are a medicine—$1 005; and

                             (ii)  if the goods are a medical device—$1 410; and

                            (iii)  in any other case—$805.

Note:          For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see regulation 4.

          (1A)  For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:

                     (a)  for grouped goods whose registration is in force at any time during the financial year to which the charge relates and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

                              (i)  if the goods are medicines—$1 410; and

                             (ii)  if the goods are medical devices—$2 765; and

                            (iii)  in any other case—$1 580; and

                     (b)  for grouped therapeutic goods:

                              (i)  whose registration is in force at any time during the financial year to which the charge relates; and

                             (ii)  that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and

                            (iii)  that are biologics;

                            $6 875; and

                     (c)  for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the financial year to which the charge relates:

                              (i)  if the goods are medicines—$1 005; and

                             (ii)  if the goods are medical devices—$1 410; and

                            (iii)  in any other case—$805.

Note:          For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see regulation 4.

       (1AA)  For subsection 4(1AA) of the Act, the annual charges for inclusion of a biological in the Register under Part 3‑2A of the Act are:

                     (a)  for a class 1 biological whose inclusion in the Register is in force at any time during the financial year to which the charge relates—$645; and

                     (b)  for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the financial year to which the charge relates—$6 395.

          (1B)  For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during a financial year are as follows:

                     (a)  for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$80;

                     (b)  for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$645;

                     (c)  for a Class IIa medical device or Class IIb medical device—$930;

                     (d)  for a Class AIMD medical device or Class III medical device—$1 200;

                     (e)  for an IVD medical device—nil.

             (2)  For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during a financial year is as follows:

                     (a)  for a licence for the manufacture of sterile or non‑sterile therapeutic goods—$12 000;

                     (b)  for a licence for the manufacture of containers in which therapeutic goods are to be packed—$12 000;

                     (c)  for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6 160;

                     (d)  for a licence for a single step in the manufacture of therapeutic goods—$6 160;

                     (e)  for a licence for the manufacture of a sterile or non‑sterile single medicine—$6 160;

                      (f)  for a licence for the manufacture of a sterile or non‑sterile single type of therapeutic device—$6 160;

                     (g)  for a licence for the manufacture of sterile or non‑sterile diagnostic goods for in vitro use—$6 160;

                     (h)  for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the Poisons Standard (other than Schedule 5 or 6)—$6 160;

                      (j)  for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence:

                              (i)  for a primary site—$154 700; and

                             (ii)  for a fixed (non‑mobile) manufacturing site—$7 615;

                    (ja)  for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$6 660;

                     (k)  for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$6 660;

                      (l)  for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$13 000;

                    (m)  despite paragraphs (a) to (l)—for a licence for the manufacture of a biological only—Nil.

             (3)  If, but for this subregulation, more than one charge referred to in subregulation (1) or any of paragraphs (2)(a) to (l) would otherwise apply in respect of a financial year in relation to:

                     (a)  the registration or listing of particular goods; or

                     (b)  a particular licence;

the charge that is the greatest applicable charge (other than a charge payable under any of paragraphs (2)(a) to (l) only because biologicals are manufactured) is the only charge that applies in respect of the registration or listing of those goods or in relation to that licence in that year.

Note:          Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3‑3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a financial year is not more than $94 500 is half the amount mentioned in subregulation (2) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.

             (4)  For subregulation (2):

haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self‑renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage‑restricted progenitor cells.

primary site means the principal premises in the capital city of each State and Territory where human blood and blood components are manufactured.

4  Annual charges for goods that are not biologics

             (1)  For the purposes of subsections 4(1) and (1A) of the Act, this regulation sets out the annual charge for the registration of therapeutic goods if:

                     (a)  the registration of the goods is in force at any time during the financial year (the charge year) to which the charge relates; and

                     (b)  the goods are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and

                     (c)  either:

                              (i)  if the goods are not grouped therapeutic goods—the goods are not a biologic; or

                             (ii)  if the goods are grouped therapeutic goods—the goods are not biologics.

When the higher and lower amounts are payable

             (2)  The annual charge for the goods for the charge year is the higher amount if any one or more of subregulations (3) to (8) apply to the goods. Otherwise, the annual charge is the lower amount.

Note:          Higher amount and lower amount are defined in subregulation (9).

Goods containing certain active ingredients

             (3)  The goods contain any of the following active ingredients:

                     (a)  thalidomide;

                     (b)  leflunomide;

                     (c)  lenalidomide;

                     (d)  mifepristone;

                     (e)  clozapine;

                      (f)  isotretinoin.

New chemical entities, extensions of indications and changes to intended patient groups

             (4)  The following conditions are met:

                     (a)  the registration of the goods commenced on or after 1 July 2015;

                     (b)  the goods are relevant goods;

                     (c)  for goods whose registration commenced before the beginning of the charge year—at the beginning of the charge year, the goods have been registered for less than 8 years.

Goods whose parent goods have been registered for less than 8 years

             (5)  The following conditions are met:

                     (a)  the registration of the goods commenced on or after 1 July 2015;

                     (b)  the goods are not relevant goods;

                     (c)  subregulation (4) applies for the charge year to the parent goods of those goods.

Grouped therapeutic goods as a result of extension of indications or changes to intended patient group

             (6)  The following conditions are met:

                     (a)  the goods are grouped therapeutic goods;

                     (b)  relevant goods that are included in those grouped goods were grouped on or after 1 July 2015 (whether or not other goods that are included in those grouped goods were registered before that time);

                     (c)  the grouping occurred in a financial year before the charge year;

                     (d)  the charge year is the year beginning 1 July 2016 or a later charge year;

                     (e)  at the beginning of the charge year, the relevant goods have been included in the grouped goods for less than 8 years.

Entries before 1 July 2015—goods that are not grouped therapeutic goods

             (7)  The following conditions are met:

                     (a)  the goods are not grouped therapeutic goods;

                     (b)  the goods (the chargeable goods) were registered before 1 July 2015;

                     (c)  immediately before 1 July 2015:

                              (i)  if there is only one active ingredient contained in the chargeable goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered; or

                             (ii)  otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the chargeable goods (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered;

                     (d)  at the beginning of the charge year, the goods have been registered for less than 8 years.

Entries before 1 July 2015—goods that are grouped therapeutic goods

             (8)  The following conditions are met:

                     (a)  the goods were grouped therapeutic goods immediately before 1 July 2015;

                     (b)  immediately before 1 July 2015:

                              (i)  if there is only one active ingredient contained in the grouped goods—any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered; or

                             (ii)  otherwise—any other goods containing the same active ingredients in the same quantitative amounts as the grouped goods (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered;

                     (c)  at the beginning of the charge year, the first of the goods to be registered have been registered for less than 8 years.

Definitions

             (9)  In this regulation:

extension of indications has the same meaning as in item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990.

higher amount means $3 920.

lower amount means $3 180.

new chemical entity has the meaning given by subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990.

parent goods: goods (the initial goods) are parent goods of other goods if:

                     (a)  the initial goods were registered before the other goods; and

                     (b)  the initial goods are relevant goods; and

                     (c)  the initial goods and the other goods have:

                              (i)  the same active ingredient; or

                             (ii)  the same active ingredients in the same quantitative amounts; and

                     (d)  at the time the registration of the other goods commenced, the other goods were registered in relation to:

                              (i)  the person in relation to whom the initial goods were registered at that time; or

                             (ii)  a person authorised by the person in relation to whom the initial goods were registered at that time.

relevant goods means goods that, at the time the registration of the goods commenced, were:

                     (a)  a new chemical entity; or

                     (b)  separate and distinct from other goods that are registered:

                              (i)  because of an extension of indications (other than an extension of indications referred to in paragraph (bc) of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990); or

                             (ii)  because of a change to the intended patient group (within the meaning of paragraph (e) of the definition of major variation in subclause 1(1) of Schedule 9 to those Regulations).


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

 

Number and year

Registration

Commencement

Application, saving and transitional provisions

1990 No. 395

6 Dec 1990

1 July 1990

 

1991 No. 85

30 Apr 1991

30 Apr 1991

1992 No. 88

14 Apr 1992

14 Apr 1992

1993 No. 140

25 June 1993

1 July 1993

1994 No. 149

2 June 1994

2 June 1994

1994 No. 223

30 June 1994

1 July 1994

1995 No. 193

30 June 1995

1 July 1995

1996 No. 132

28 June 1996

1 July 1996

1997 No. 161

30 June 1997

1 July 1997

1998 No. 246

31 July 1998

1 Aug 1998

1998 No. 260

12 Aug 1998

12 Aug 1998

2000 No. 71

12 May 2000

1 July 2000

2000 No. 125

22 June 2000

1 July 2000

2000 No. 266

28 Sept 2000

28 Sept 2000

2001 No. 161

29 June 2001

1 July 2001

2002 No. 144

27 June 2002

1 July 2002

2002 No. 235

4 Oct 2002

4 Oct 2002 (r 2)

2003 No. 152

26 June 2003

1 July 2003

2004 No. 160

25 June 2004

1 July 2004

2005 No. 194

19 Aug 2005 (F2005L02314)

20 Aug 2005

2006 No. 213

10 Aug 2006 (F2006L02570)

11 Aug 2006

2007 No. 162

25 June 2007 (F2007L01523)

1 July 2007

2008 No. 118

20 June 2008 (F2008L01351)

1 July 2008

2009 No. 142

25 June 2009 (F2009L02018)

1 July 2009

r. 4

2009 No. 180

9 July 2009 (F2009L02091)

10 July 2009

2010 No. 131

18 June 2010 (F2010L01283)

1 July 2010

2011 No. 31

16 Mar 2011 (F2011L00431)

31 May 2011 (r 2)

2011 No. 103

21 June 2011 (F2011L01097)

1 July 2011

2012 No. 144

29 June 2012 (F2012L01457)

31 May 2011

2012 No. 145

29 June 2012 (F2012L01462)

1 July 2012

94, 2013

3 June 2013 (F2013L00896)

1 July 2013

61, 2014

30 May 2014 (F2014L00631)

1 July 2014

86, 2015

18 June 2015 (F2015L00839)

1 July 2015 (r 2(1) item 1)

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Charges) Amendment (2016 Measures No. 1) Regulation 2016

5 May 2016 (F2016L00668)

1 July 2016 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

 

r. 1............................................

rs 1998 No. 260

r 2.............................................

am 2000 No. 71; 2002 No. 235; 2003 No. 152; 2011 No. 31

 

r 3.............................................

am 1991 No. 85; 1992 No. 88; 1993 No. 140; 1994 Nos. 149 and 223; 1995 No. 193; 1996 No. 132; 1997 No. 161; 1998 No. 246; 2000 Nos. 71, 125 and 266; 2001 No. 161; 2002 Nos. 144 and 235; 2003 No. 152; 2004 No. 160; 2005 No. 194; 2006 No. 213; 2007 No. 162; 2008 No. 118; 2009 No. 180; 2010 No. 131; 2011 Nos. 31 and 103; 2012 Nos. 144 and 145; No. 94, 2013; No 61, 2014; No 86, 2015; F2016L00668

 

r 4.............................................

am 1992 No. 88; 1993 No. 140; 1998 No. 246; F2016L00668

 

 

rep 1998 No. 260

 

 

ad No 86, 2015

 

r 4A..........................................

ad 1994 No. 149

 

 

rep 2011 No. 31

 

r 4B...........................................

ad 1998 No. 260

 

 

am 2002 No. 235

 

 

rep 2009 No. 142

 

r 4C...........................................

ad 1998 No. 260

 

 

am 2001 No. 161; 2002 Nos. 144 and 235; 2003 No. 152

 

 

rep 2009 No. 142

 

r 4D..........................................

ad 1998 No. 260

 

 

rep 2009 No. 142

 

r 4E...........................................

ad 1998 No. 260

 

 

am 2002 Nos. 144 and 235; 2003 No. 152; 2004 No. 160; 2005 No. 194; 2006 No. 213; 2007 No. 162; 2008 No. 118

 

 

rep 2009 No. 142

 

r 4F...........................................

ad 1998 No. 260

 

 

am 2002 No. 235

 

 

rep 2009 No. 142

 

r 5.............................................

am 1991 No. 85; 1998 No. 260; 2002 No. 235

 

 

rep 2009 No. 142