Therapeutic Goods (Charges) Regulations 1990 (Cth)
made under the
This is a compilation of the
The notes at the end of this compilation
(the
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 ( 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.
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.
For more information about any editorial changes made in this compilation, see the endnotes.
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.
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
These Regulations are the
Therapeutic Goods (Charges) Regulations 1990 .
(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 theTherapeutic Goods Regulations 1990 .Class 2 biological has the same meaning as in theTherapeutic Goods Regulations 1990 .Class 3 biological has the same meaning as in theTherapeutic Goods Regulations 1990 .Class 4 biological has the same meaning as in theTherapeutic Goods Regulations 1990 .Poisons Standard has the same meaning ascurrent Poisons Standard in Part 5B of theTherapeutic Goods Act 1989 .the Act means theTherapeutic 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 .
(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—$1,430; and
(ii) if the goods are a medical device—$2,810; and
(iii) in any other case—$1,610; 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;
$6,990; 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—$1,020; and
(ii) if the goods are a medical device—$1,430; and
(iii) in any other case—$820.
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—$1,430; and
(ii) if the goods are medical devices—$2,810; and
(iii) in any other case—$1,610; 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;
$6,990; 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—$1,020; and
(ii) if the goods are medical devices—$1,430; and
(iii) in any other case—$820.
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—$660; 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—$6,500.
(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—$610;
(c) for a Class IIa medical device or Class IIb medical device—$880;
(d) for a Class AIMD medical device or Class III medical device—$1,140;
(e) for an IVD medical device (other than a medical device to which paragraph (f) applies)—$660;
(f) for a Class 4 in‑house 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—$12,200;
(b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$12,200;
(c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$6,260;
(d) for a licence for a single step in the manufacture of therapeutic goods—$6,260;
(e) for a licence for the manufacture of a sterile or non‑sterile single medicine—$6,260;
(f) for a licence for the manufacture of a sterile or non‑sterile single type of therapeutic device—$6,260;
(g) for a licence for the manufacture of sterile or non‑sterile diagnostic goods for in vitro use—$6,260;
(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)—$6,260;
(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—$157,300; and
(ii) for a fixed (non‑mobile) manufacturing site—$7,740;
(ja) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$6,770;
(k) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$6,770;
(l) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$13,200;
(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 theTherapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a financial year is not more than $96,100 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.
(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 andlower 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 theTherapeutic Goods Regulations 1990 .higher amount means $3,980.lower amount means $3,230.new chemical entity has the meaning given by subclause 1(1) of Schedule 9 to theTherapeutic Goods Regulations 1990 .parent goods : goods (theinitial goods ) areparent 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).
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
The abbreviation key sets out abbreviations that may be used in the endnotes.
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.
The
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.
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.
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
= | Sch = Schedule(s) |
LIA
= | 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 | |
No. = Number(s) | commenced or to be commenced |
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) | — |
Therapeutic Goods (Charges) Amendment (2016 Measures No. 1) Regulation 2016 | 5 May 2016 (F2016L00668) | 1 July 2016 (s 2(1) item 1) | — |
Therapeutic Goods (Charges) Amendment (2017 Measures No. 1) Regulations 2017 | 19 May 2017 (F2017L00554) | 1 July 2017 (s 2(1) item 1) | — |
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; F2017L00554 | |
r 4................................................. | am 1992 No 88; 1993 No 140; 1998 No 246; F2016L00668 | |
rep 1998 No 260 | ||
ad No 86, 2015 | ||
am F2017L00554 | ||
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 | ||
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