Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L00589 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Therapeutic Goods (Charges) Act 1989

 

Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022

 

The instrument increases annual charges for therapeutic goods to support cost recovery.

 

The Therapeutic Goods (Charges) Act 1989 (the Act) imposes annual charges on the registration, listing and inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and on the licensing of manufacturers of therapeutic goods (other than medical devices). The Therapeutic Goods Administration (the TGA), which is part of the Department of Health (the Department), is responsible for administering the Act.

 

Subsection 5(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing the amounts of charges. Subsection 5(2) of the Act provides in part that the regulations may prescribe different charges in relation to different classes of goods (including medical devices) or, in the case of annual licensing charges, for different steps in the manufacture of therapeutic goods.

 

Section 4 of the Act provides that annual charges of such amounts as are prescribed are payable in respect of therapeutic goods on the Register, as well as in respect of manufacturing licences and conformity assessment body determinations, that are in force at any time within a financial year. In addition, under subsection 4(1A) of the Act, where one or more therapeutic goods are “grouped” and each of the “grouped” therapeutic goods is covered by a single registration or listing number, a single annual charge as is prescribed will apply for maintaining all the registered or listed goods covered under the same group.  

 

The main purpose of the Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022 (the Regulations) is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to increase the annual charges set out in those regulations for most products by 2.6 per cent, for the financial year 2022-23.  The Regulations complement the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022 which increase fees for therapeutic goods for 2022-23 by the same rate. The implementation of the proposed increase through two separate instruments reflects that the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022 amends the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002, which are made under the Therapeutic Goods Act 1989 and, relevantly, impose fees for services, while the Charges Regulations are made under the Therapeutic Goods (Charges) Act 1989 (and impose taxes).

 

The increase applies to annual charges relating to the registration, listing or inclusion of therapeutic goods in the Register. This encompasses registered goods (including provisionally registered medicines), listed goods, biologicals and medical devices.

 

The 2.6 per cent increase is based on an indexation formula used to calculate adjustments to TGA fees and charges in most previous years, and is based on the Australian Bureau of Statistics’ Wages Price Index (50 per cent) (in this case, for the year to September 2021) and Consumer Price Index (50 per cent) (also for the same period). This increase is in line with the TGA’s cost recovery model.

 

 

Details of the Regulations are set out in the Attachment.

 

The Act specifies no conditions that need to be satisfied before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislation Act 2003.

 

The Regulations commence on 1 July 2022.

 

Consultation

In relation to consultation, the TGA held bilateral meetings with 13 key industry representative bodies in December 2021 to consult on the proposed revision of TGA fees and charges for 2022-23. The industry bodies included Medicines Australia, the Generic and Biosimilar Medicines Association, AusBiotech, the Medical Technology Association of Australia, Consumer Healthcare Products Australia, Complementary Medicines Australia and Accord Australasia. A majority of the bodies indicated their support for the proposed 2.6 per cent increase.

 

The TGA also undertook public consultation to obtain broader stakeholder feedback, with a consultation paper released on the TGA website and submissions sought from 25 January 2022 to 7 March 2022. 14 submissions were received, including ten from industry representative bodies, two from sponsors or manufacturers, one from a professional body and one from an individual. Of these:

  • nine (including seven industry bodies) confirmed their support for the proposed increase;
  • three (including two industry bodies, the Optical Distributors & Manufacturers Association of Australia Ltd and Assistive Technology Suppliers Australia) did not support the proposed increase, for a number of reasons including in particular the impact of COVID-19 and the impact on the costs of doing business;
  • one did not object to the proposed increase; and
  • one proposed a higher (3.6 per cent) increase.

 

Authority:  Subsection 5(1) of the Therapeutic Goods (Charges) Act 1989

ATTACHMENT

 

Details of the Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022

 

Section 1 – Name

This section provides for the Regulations to be referred to as the Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022.

 

Section 2 – Commencement

This section provides for the commencement of the Regulations on 1 July 2022.

 

Section 3 – Authority

This section provides that the Regulations are made under the Therapeutic Goods (Charges) Act 1989.

 

Section 4 – Schedules

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

 

 

Schedule 1 – Amendments

 

Therapeutic Goods (Charges) Regulations 2018

 

Items [1]-[27]

These items amend each of the amounts of annual charges prescribed in the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) by 2.6 per cent, from 1 July 2022.

 


Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022

 

The Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022 (the Regulations) are compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the Legislative Instrument

The Regulations are made under subsection 5(1) of the Therapeutic Goods (Charges) Act 1989 (the Act). The main purpose of the Regulations is to amend the Therapeutic Goods (Charges) Regulations 2018 (the Charges Regulations) to increase the annual charges set out in those regulations for most products by 2.6 per cent, for the financial year 2022-23. The Regulations complement the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022, which increase fees for therapeutic goods for 2022-23 by the same rate.

 

The increase applies in particular to annual charges relating to the registration, listing or inclusion of therapeutic goods in the Australian Register of Therapeutic Goods. This encompasses registered goods (including provisionally registered medicines), listed goods, biologicals and medical devices.

 

The 2.6 per cent increase is based on an indexation formula used to calculate adjustments to Therapeutic Goods Administration (TGA) fees and charges in most previous years, and is based on the Australian Bureau of Statistics’ Wages Price Index (50 per cent) (in this case, for the year to September 2021) and Consumer Price Index (50 per cent) (also for the same period). This increase is in line with the TGA’s cost recovery model.

 

Human rights implications

As the Regulations do not introduce any changes to the Charges Regulations other than to implement the changes outlined above, they do not engage any of the applicable rights or freedoms.

 

Conclusion

The Regulations are compatible with human rights as they do not raise any human rights issues.

 

Greg Hunt, Minister for Health and Aged Care

 

 

Overview

The Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022 were enacted to address the need for cost recovery in relation to the annual charges imposed under the Therapeutic Goods (Charges) Act 1989. This Act, enacted in 1989, imposes annual charges on the registration, listing, and inclusion of therapeutic goods in the Australian Register of Therapeutic Goods and on the licensing of manufacturers of therapeutic goods (excluding medical devices). The Therapeutic Goods Administration (TGA), a part of the Department of Health, administers the Act. The Regulations, introduced by the Australian Government, aim to increase the annual charges for most therapeutic goods by 2.6 per cent for the financial year 2022-23. This increase aligns with the TGA’s cost recovery model and is based on the Australian Bureau of Statistics’ Wages Price Index and Consumer Price Index for the year to September 2021. The Regulations are designed to complement the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022, which also increase fees for therapeutic goods by the same rate. The proposed increase was supported by most industry bodies consulted by the TGA.

Scope and Application

The Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022 primarily concern the annual charges imposed by the Therapeutic Goods (Charges) Act 1989 on the registration, listing, and inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, as well as on the licensing of manufacturers of therapeutic goods (excluding medical devices). Administered by the Therapeutic Goods Administration (TGA), part of the Department of Health, these charges are intended to support cost recovery. The Regulations amend the Therapeutic Goods (Charges) Regulations 2018 by increasing the annual charges for most products by 2.6 per cent for the financial year 2022-23, aligning with the TGA’s cost recovery model based on the Australian Bureau of Statistics’ Wages Price Index and Consumer Price Index. This adjustment applies to registered goods, listed goods, biologicals, and medical devices, and takes effect from 1 July 2022. The Regulations are consistent with the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022, which also increase fees for therapeutic goods by the same rate. The TGA consulted with key industry representative bodies and the public on the proposed revision of fees and charges, with a majority of respondents supporting the increase. The Regulations are compatible with human rights as they do not alter the Charges Regulations beyond the outlined adjustments.

Key Provisions

The Therapeutic Goods (Charges) Amendment (2022 Measures No. 1) Regulations 2022 (the Regulations) serve to amend the Therapeutic Goods (Charges) Regulations 2018, increasing the annual charges for most therapeutic goods by 2.6% for the financial year 2022-23. This adjustment applies to charges associated with the registration, listing, or inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, which includes registered goods, listed goods, biologicals, and medical devices. This increase is calculated using an indexation formula based on the Australian Bureau of Statistics’ Wages Price Index and Consumer Price Index, reflecting the Therapeutic Goods Administration’s (TGA) cost recovery model (Section 1). Entities or individuals responsible for the registration, listing, or inclusion of therapeutic goods in the Register are required to pay the increased annual charges as outlined in the Regulations. These charges must be paid in respect of therapeutic goods that are registered or listed, and for manufacturing licenses, in accordance with the provisions of the Therapeutic Goods (Charges) Act 1989 (the Act) (Section 4). Additionally, where therapeutic goods are grouped under a single registration or listing number, a single annual charge applies to all grouped goods (subsection 4(1A) of the Act). Failure to comply with the payment of the increased annual charges as prescribed by the Regulations may result in civil or administrative penalties. However, the specific consequences for non-compliance are not detailed in the explanatory statement. The Regulations are made under the authority of subsection 5(1) of the Therapeutic Goods (Charges) Act 1989 and are a legislative instrument for the purposes of the Legislation Act 2003. The Regulations commence on 1 July 2022.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.