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Therapeutic Goods (Charges) Regulations 2018

Authoritative Version
  • - F2018L00774
  • In force - Superseded Version
  • View Series
Regulations as made
These regulations repeal and replace the Therapeutic Goods (Charges) Regulations 1990, which are due to sunset on 1 October 2018 pursuant to the Legislation Act 2003.
Administered by: Health
Registered 14 Jun 2018
Tabling HistoryDate
Tabled HR18-Jun-2018
Tabled Senate19-Jun-2018

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Charges) Regulations 2018

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 07 June 2018

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

 

  

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

1............ Name............................................................................................................................. 1

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

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

5............ Definitions..................................................................................................................... 1

6............ Classes of medical devices and biologicals.................................................................... 2

Part 2—Charges                                                                                                                                                3

7............ Annual charges for biologics and some other goods..................................................... 3

8............ Annual charges for goods that are not biologics............................................................ 5

9............ Annual charges for provisionally registered medicines................................................. 8

Schedule 1—Repeals                                                                                                                                       9

Therapeutic Goods (Charges) Regulations 1990                                                                            9

 


Part 1Preliminary

  

1  Name

                   This instrument is the Therapeutic Goods (Charges) Regulations 2018.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

The day after this instrument is registered.

15 June 2018

2.  Sections 5 and 6, Part 2 and Schedule 1

1 July 2018.

1 July 2018

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the Therapeutic Goods (Charges) Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

5  Definitions

Note:          Subsection 3(1) of the Act incorporates the Therapeutic Goods Act 1989. A number of expressions used in this instrument are defined in the Therapeutic Goods Act 1989, including the following:

(a)    biological (see also section 6 for classes of biological, but see the note to the definition of biologic);

(b)    current Poisons Standard;

(c)    grouped therapeutic goods;

(d)    medical device (see also section 6 for classes of medical device);

(e)    medicine;

(f)    Register;

(g)    registered goods;

(h)    therapeutic goods.

                   In this instrument:

Act means the Therapeutic Goods (Charges) Act 1989.

biologic means therapeutic goods in which the active ingredient is a substance of biological origin (within the ordinary meaning of the term “biological”) 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 substances of biological origin of the type described. Herbal substances and antibiotics are not.

Note:          The term “biological” is not used in this definition as defined in the Therapeutic Goods Act 1989.

charge year, in relation to an annual charge, means the financial year to which the charge relates.

haematopoietic progenitor cells has the same meaning as in Schedule 9 of the Therapeutic Goods Regulations 1990.

parent goods: see subsection 8(7).

relevant goods: see subsection 8(5).

6  Classes of medical devices and biologicals

                   In this instrument:

                     (a)  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; and

                     (b)  a reference to a biological of a particular class is a reference to a biological of that class within the meaning of the Therapeutic Goods Regulations 1990.

Part 2Charges

  

7  Annual charges for biologics and some other goods

Registration or listing of non‑grouped therapeutic goods

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

                     (a)  for goods whose registration is in force at any time during the charge year 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—$1,460; and

                             (ii)  if the goods are a medical device—$2,860; and

                            (iii)  in any other case—$1,640; and

                     (b)  for goods:

                              (i)  whose registration is in force at any time during the charge year; 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;

                            $7,120; and

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

                              (i)  if the goods are a medicine—$1,120; and

                             (ii)  if the goods are a medical device—$1,460; and

                            (iii)  in any other case—$840.

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 section 8.

Registration or listing of grouped therapeutic goods

             (2)  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 charge year 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—$1,460; and

                             (ii)  if the goods are medical devices—$2,860; and

                            (iii)  in any other case—$1,640; and

                     (b)  for grouped therapeutic goods:

                              (i)  whose registration is in force at any time during the charge year; 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;

                            $7,120; 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 charge year:

                              (i)  if the goods are medicines—$1,120; and

                             (ii)  if the goods are medical devices—$1,460; and

                            (iii)  in any other case—$840.

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 section 8.

Biologicals

             (3)  For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are:

                     (a)  for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$670; 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 charge year—$6,620.

Medical devices

             (4)  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 the charge year are as follows:

                     (a)  for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$90;

                     (b)  for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$620;

                     (c)  for a Class IIa medical device or Class IIb medical device—$900;

                     (d)  for a Class AIMD medical device or Class III medical device—$1,160;

                     (e)  for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$670;

                      (f)  for a Class 4 in‑house IVD medical device—nil.

Licences

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

                     (a)  for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$4,590;

                     (b)  for a licence for the manufacture of containers in which therapeutic goods are to be packed—$4,590;

                     (c)  for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$4,590;

                     (d)  for a licence for the manufacture of a sterile or non‑sterile single type of therapeutic device—$6,380;

                     (e)  for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$4,590;

                      (f)  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 the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$160,300; and

                             (ii)  for a fixed (non‑mobile) manufacturing site—$7,890;

                     (g)  for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$6,900;

                     (h)  for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence—$6,900;

                      (i)  for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$13,500;

                      (j)  despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil.

Only highest applicable charge is payable

             (6)  If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to:

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

                     (b)  a particular licence;

only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.

Note 1:       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 charge year is not more than $97,900 is half the amount mentioned in subsection (5) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.

Note 2:       For provisional registration of a medicine, see section 9.

8  Annual charges for goods that are not biologics

             (1)  For the purposes of subsections 4(1) and (1A) of the Act, this section 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 charge year; 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 higher and lower amounts are payable

             (2)  The annual charge for the goods for the charge year is:

                     (a)  if one or more of the conditions in subsections (3) to (10) apply to the goods—$4,060; or

                     (b)  otherwise—$3,290.

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 fewer than 8 years.

             (5)  Relevant goods are goods that, at the time the registration of the goods commenced, were:

                     (a)  a new chemical entity, within the meaning of subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990; or

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

                              (i)  because of an extension of indications, within the meaning of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990, other than an extension of indications mentioned in paragraph (bc) of that item; 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).

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

             (6)  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)  subsection (4) applies for the charge year to the parent goods of those goods.

             (7)  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.

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

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

Entries before 1 July 2015—goods other than grouped therapeutic goods

             (9)  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 fewer than 8 years.

Entries before 1 July 2015—grouped therapeutic goods

           (10)  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 fewer than 8 years.

Note:          For provisional registration of a medicine, see section 9.

9  Annual charges for provisionally registered medicines

             (1)  For the purposes of subsection 4(1) of the Act, the annual charges for the provisional registration of a medicine, if the provisional registration is in force at any time during the charge year, are:

                     (a)  for goods that are a biologic—$16,100; and

                     (b)  for goods that are not a biologic—$13,100.

             (2)  If a provisional registration for a medicine is in force at any time in a charge year, and the medicine is otherwise registered later in the same charge year, sections 7 and 8 do not apply in relation to its registration in respect of that charge year.


Schedule 1Repeals

  

Therapeutic Goods (Charges) Regulations 1990

1  The whole of the instrument

Repeal the instrument.