Therapeutic Goods Amendment Regulations 2010 (No. 3)

Administered by Department of Health, Disability and Ageing

Legislation au F2010L01282 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Select Legislative Instrument 2010 No. 130

 

Therapeutic Goods Act 1989

 

Therapeutic Goods Amendment Regulations 2010 (No. 3)

 

Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 2)

 

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety and efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

 

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The purpose of the Regulations is to increase certain fees in the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) by 2.4 per cent.

 

The fees increased in the TG Regulations apply to application fees for registration or listing on the Australian Register of Therapeutic Goods (the Register), application fees for manufacturing licences, evaluation fees, clinical trial notification fees, application fees for export certificates and inspection fees for manufacturing premises.

 

The fees increases in the MD Regulations apply to fees relating to conformity assessments and abridged conformity assessments of medical devices, applications for inclusion of medical devices in the Register and conformity assessment certificates for medical devices.

 

The 2.4 per cent increase of fees is a general composite increase that has been calculated using a formula agreed between the TGA and industry associations.  The fees in the TG Regulations and the MD Regulations were last increased in July 2009 and the increase is comprised of 50 per cent of the Labour Price Index from September 2008 to September 2009 and 50 per cent of the Consumer Price Index from September 2008 to September 2009.

 

The increases to fees prescribed in both sets of Regulations have been rounded to the nearest $10 for amounts less than $10,000 and to the nearest $100 for amounts greater than $10,000.  As a result of this rounding policy, fee items that are $200 or less do not change.

 

The amendments to the TG Regulations and the MD Regulations, when taken together with  changes to the Therapeutic Goods (Charges) Regulations 1990 (which are the subject of a separate Minute), are expected to increase the fees and charges collected by the TGA by $2.4 million (to $102.9 million) over the 2010-11 financial year.

 

The increases enable the TGA to recover its costs in administering the Act and continue to meet the Government’s Cost Recovery Guidelines.

 

Details of the amendments to the TG Regulations are set out in Attachment A and details of the amendments to the MD Regulations are set out in Attachment B.

 

The TGA consulted with industry on the 2009-10 financial forecast and outlook for financial year 2010-11 in bilateral meetings held in February 2010.  These meetings provided an opportunity for industry to present relevant information to be taken into account as part of the TGA’s assessment and estimate of its regulatory workload and costs for financial year

2010-11.

 

The TGA and industry associations agreed in the past to use an indexation model to adjust fees and charges annually (with additional increases to be justified to industry), in line with cost and wage movements in the public sector.  That indexation model is comprised of 50 per cent of the Australian Bureau of Statistics’ wage-cost index, which reflects average wage movements, and 50 per cent of the Consumer Price Index.  The 2.4 per cent increase in fees and charges that would be effected by the Regulations would be consistent with the

TGA-industry agreement on increases to fees and charges.

 

A regulatory impact statement (RIS) was not prepared in relation to the Regulations, and the Office of Best Practice Regulation confirmed that as the proposed amendments would have a no to low regulatory impact on business or individuals, a RIS was not required.

 

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

 

The Regulations are legislative instruments for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commence on 1 July 2010.

 

 


ATTACHMENT A

 

Details of the Therapeutic Goods Amendment Regulations 2010 (No. 3)

 

Regulation 1 – Name of Regulations

This regulation provides for the Regulations to be referred to as the Therapeutic Goods Amendment Regulations 2010 (No. 3).

 

Regulation 2 – Commencement

This regulation provides for the Regulations to commence on 1 July 2010.

 

Regulation 3 – Amendment of Therapeutic Goods Regulations 1990

This regulation provides for Schedule 1 to amend the Therapeutic Goods Regulations 1990 (the TG Regulations).

 

Schedule 1 –Amendments

 

Item [1] – Regulation 43AAJ, heading

Subregulation 43AAJ(1) of the TG Regulations currently provides that the annual charge payable by a person required to hold a manufacturing licence under Part 3-3 of the 1989 Act and whose turnover of therapeutic goods is not more than $76,800 in a financial year, is reduced in the manner described in subregulation 43AAJ(2).

 

Item [3] (below) amends paragraph 43AAJ(1)(b) to increase the threshold amount of $76,800 by 2.4 per cent (subject to the TGA’s rounding policy) to $78,600.

 

Accordingly, this item amends the heading of regulation 43AAJ to reflect that increase.

 

Item [2] – Regulation 45A, heading

Regulation 45A of the TG Regulations provides that if the total amount payable under item 3AB of Schedule 9 to the TG Regulations for applications to which subparagraph 43AAC(2)(b)(iii) of the TG Regulations (low value turnover application requirements) applies reaches $13,000 in a financial year, the applicant is not required to pay any further amounts for applications under subparagraph 43AAC(2)(b)(iii) in the financial year.

 

Item [2] substitutes the current heading of regulation 45A with a clearer, more relevant heading.

 

Item [3] – Further amendments

Item [3] increases most fees in regulation 45 and Part 2 of Schedule 9 to the TG Regulations by 2.4 per cent, subject to the TGA’s rounding policy.  This increase affects fees relating to a range of matters, including application fees for registration or listing on the Australian Register of Therapeutic Goods, application fees for manufacturing licences, evaluation fees, clinical trial notification fees, application fees for export certificates and inspection fees for manufacturing premises.

 

This item also increases the amount specified in paragraph 43AAJ(1)(b) of the TG Regulations by 2.4 per cent to $78,600 subject to the TGA’s rounding policy.  This item increases various fees specified in subregulations 45(4A), 45(9) and 45(11) of the

TG Regulations by approximately 2.4 per cent subject to the TGA’s rounding policy. 


ATTACHMENT B

 

Details of the Therapeutic Goods (MEDICAL DEVICES) Amendment Regulations 2010 (No. 2)

 

Regulation 1 – Name of Regulations

This regulation provides for the Regulations to be referred to as the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 2).

 

Regulation 2 - Commencement

This regulation provides for the Regulations to commence on 1 July 2010.

 

Regulation 3 – Amendment of Therapeutic Goods (Medical Devices) Regulations 2002

This regulation provides for Schedule 1 to amend the Therapeutic Goods (Medical Devices) Regulations 2002.

 

Schedule 1 –Amendments

 

Item [1] – Amendment of fees

This item increases the fee for an abridged conformity assessment of a medical device, set out in paragraph 9.4(2)(b) of the Therapeutic Goods (Medical Devices) Regulations 2002, by

2.4 per cent.

 

This item also increases the fees for all relevant items in Part 1 of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002 by 2.4 per cent.

 

This item also increases the hourly fee of $320 specified in paragraph 2.1 (b) of Part 2 of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, for preparation by an assessor for a conformity assessment or a review of a conformity assessment certificate outside Australia, by 2.4 per cent, to $330.

 

Overview

The Therapeutic Goods Amendment Regulations 2010 (No. 3) and the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 2) are legislative instruments made under the Therapeutic Goods Act 1989. These Regulations were enacted to address the need for periodic adjustments to the fees associated with the regulation and oversight of therapeutic goods and medical devices in Australia. The Therapeutic Goods Administration (TGA), which administers the Act, proposed these amendments to align the fees with the cost of living and wage movements, ensuring that the TGA can continue to effectively regulate and maintain the quality, safety, and efficacy of therapeutic goods within Australia. The fee increases, amounting to a general composite increase of 2.4 per cent, were calculated using a formula agreed upon by the TGA and industry associations, reflecting 50 per cent of the Labour Price Index and 50 per cent of the Consumer Price Index from September 2008 to September 2009. The Regulations were designed to ensure that the TGA can recover its costs in administering the Act and meet the Government’s Cost Recovery Guidelines, with the increases taking effect from 1 July 2010.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) establishes a national system of controls to ensure the quality, safety, and efficacy of therapeutic goods used in or exported from Australia. The Act applies to various entities and individuals involved in the manufacturing, registration, listing, and distribution of therapeutic goods, as well as medical devices. The Therapeutic Goods Administration (TGA) is the body responsible for administering the Act, ensuring compliance with its provisions. The Act extends its reach nationally across Australia, thereby encompassing all states and territories. The scope of the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 2) and the Therapeutic Goods Amendment Regulations 2010 (No. 3) is to adjust fees associated with the regulation of therapeutic goods and medical devices by 2.4 per cent, in line with cost and wage movements. This adjustment is calculated using a formula agreed upon by the TGA and industry associations, incorporating the Labour Price Index and the Consumer Price Index from September 2008 to September 2009. These amendments are designed to enable the TGA to recover its costs and comply with the Government's Cost Recovery Guidelines. The fees increased apply to various activities such as application fees for registration or listing, manufacturing licences, evaluation fees, and conformity assessments. The regulations came into effect on 1 July 2010, and no regulatory impact statement was prepared as the amendments were considered to have a no to low regulatory impact on businesses or individuals.

Key Provisions

The Therapeutic Goods Amendment Regulations 2010 (No. 3) and the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 2) (collectively, the Regulations) are designed to increase various fees associated with the administration of the Therapeutic Goods Act 1989 (the Act) by 2.4 per cent. This adjustment, as detailed in the Explanatory Statement, is primarily to align with the Therapeutic Goods Administration's (TGA) financial requirements and the Government's Cost Recovery Guidelines. Specifically, Section 63(1) of the Act allows the Governor-General to enact these Regulations, ensuring they are not inconsistent with the Act and are necessary for its effective administration. The Regulations impose several obligations on parties subject to the Act. These include pharmaceutical companies, medical device manufacturers, and other entities dealing with therapeutic goods. They must comply with the fee structure outlined in the Regulations, which now includes a 2.4 per cent increase across various application fees, evaluation fees, clinical trial notifications, and conformity assessments. The Regulations also require the TGA to continue its consultations with industry associations to ensure that fee adjustments are justified and reflect economic indicators like the Labour Price Index and the Consumer Price Index. Failure to comply with the fee provisions set out in the Regulations may result in legal consequences. While the Explanatory Statement does not explicitly detail specific offences or penalties, non-compliance with the Act generally could lead to enforcement actions by the TGA, including fines or other sanctions. The TGA is empowered to take action against entities that fail to adhere to the prescribed fee structures or other regulatory requirements. In summary, the Regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 by increasing fees by 2.4 per cent to help the TGA recover its costs and continue to meet its financial obligations. These amendments require regulated entities to adjust their financial commitments accordingly, and while specific penalties for non-compliance are not detailed, the Act provides the TGA with the authority to enforce compliance through various means.

Legal classification tags

Area of Law
Regulatory Standards
Instrument
Regulation
Concepts
Definitions & Interpretation
Fees
Regulatory Standards

Interactions

Authorises

All Versions

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.