Therapeutic Goods (Charges) Regulations 1990

Statutory Rules 1990 No. 395 as amended

made under the

Therapeutic Goods (Charges) Act 1989

This compilation was prepared on 1 July 2011
taking into account amendments up to SLI 2011 No. 103

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Contents

 1 Name of regulations [see Note 1]

 2 Interpretation 

 3 Annual charges 

Notes   

1 Name of regulations [see Note 1]

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

 (i) if the goods are a medicine — $1 210; and

 (ii) if the goods are a medical device — $2 390; and

 (iii) in any other case — $1 360; and

 (b) for goods of a kind whose registration is in force at any time during the financial year to which the charge relates and that is mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

 (i) if the goods are a biologic — $5 920; and

 (ii) if the goods are not a biologic — $3 550; 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 — $860; and

 (ii) if the goods are a medical device — $1 210; and

 (iii) in any other case — $690.

 (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 not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

 (i) if the goods are medicines — $1 210; and

 (ii) if the goods are medical devices — $2 390; and

 (iii) in any other case — $1 360; and

 (b) for grouped goods whose registration is in force at any time during the financial year to which the charge relates and that are mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:

 (i) if the goods are biologics — $5 920; and

 (ii) if the goods are not biologics — $3 550; 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 — $860; and

 (ii) if the goods are medical devices — $1 210; and

 (iii) in any other case — $690.

 (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 — $550; 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 — $5 500.

 (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) — $60;

 (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function — $550;

 (c) for a Class IIa medical device or Class IIb medical device — $840;

 (d) for a Class AIMD medical device or Class III medical device — $1 090;

 (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 — $10 300;

 (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed — $10 300;

 (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods — $5 300;

 (d) for a licence for a single step in the manufacture of therapeutic goods — $5 300;

 (e) for a licence for the manufacture of a sterile or non‑sterile single medicine — $5 300;

 (f) for a licence for the manufacture of a sterile or non‑sterile single type of therapeutic device — $5 300;

 (g) for a licence for the manufacture of sterile or non‑sterile diagnostic goods for in vitro use — $5 300;

 (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) — $5 300;

 (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 — $133 100; and

 (ii) for a fixed (non-mobile) manufacturing site — $6 550;

 (ja) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence — $5 730;

 (k) for a licence for a single step in the manufacture of a single human tissue at manufacturing premises covered by the licence — $5 730;

 (l) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence — $11 200.

 (3) If, but for this subregulation, more than one charge referred to in subregulation (1) or (2) 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 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 $81 300 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.

Notes to the Therapeutic Goods (Charges) Regulations 1990

Note 1

The Therapeutic Goods (Charges) Regulations 1990 (in force under the Therapeutic Goods (Charges) Act 1989) as shown in this compilation comprise Statutory Rules 1990 No. 395 amended as indicated in the Tables below.

For all relevant information pertaining to application, saving or transitional provisions see Table A.

Table of Instruments

Table of Amendments

Table A Application, saving or transitional provisions

Select Legislative Instrument 2009 No. 142

4 Transitional

  Despite the repeal of regulations 4B, 4C, 4D, 4E, 4F and 5, those regulations continue to apply after 1 July 2009 in relation to working out whether the annual charges mentioned in those regulations are payable by a person for the financial year beginning on 1 July 2008 and all earlier financial years.