Therapeutic Goods Regulations (Amendment)

Administered by Department of Health, Disability and Ageing

Legislation au F1997B02690 Regulations Not in force Legislative Instrument

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Therapeutic Goods Regulations (Amendment) 1997 No. 162

EXPLANATORY STATEMENT

STATUTORY RULES 1997 No. 162

Issued by authority of the Parliamentary Secretary to the Minister for Health and Family Services for the Minister for Health and Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 ("the Act") provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) has the responsibility of administering the Act. The TGA operates from the Therapeutic Goods Administration Trust Account, established under the Audit Act 1901 and referred to in section 45 of the Act.

Section 63 of the Act provides that the Governor-General may make Regulations for the purposes of the Act.

Subsection 63(1) and paragraphs 63(2)(h) and 63(3)(a) of the Act enable the Governor-General to make regulations prescribing a range of application, processing or evaluation fees payable in connection with the processing of applications to include therapeutic goods in the Australian Register of Therapeutic Goods (the Register) and the variation of information contained in the Register about those goods. Paragraph 63(2)(g) permits fees to be prescribed for the evaluation of data concerning therapeutic goods or the inspection of manufacturing operations. Paragraph 63(3)(b) provides that regulations may also be made for the refund, reduction or waiving of fees or charges in cases identified in the Regulations.

The introduction of the Act in 1991 was accompanied by a Government requirement that TGA recover 50 per cent of its operating costs through fees and charges levied on industry. The level of cost recovery by the TGA was increased in 1996 with an initial increase to 58 per cent in 1996/97 and proposed increases to 67 per cent and 75 per cent in successive financial years. The rate of increase in cost recovery was accelerated as part of the 1997/98 Budget to recover 75 per cent of operating costs in 1997/98. The amendments contained in the amending Regulations, together with amendments to the Therapeutic Goods (Charges) Act 1989, will enable the TGA to recover 75 per cent of its operating costs through both annual charges and the collection of application and evaluation fees and inspection fees. Agreement was reached with industry for the latest increase to apply from 1 July 1997.

The Regulations provide for the agreed increases to the existing range of application fees, processing fees and evaluation fees currently applying under Regulation 45 and Schedule 9 of the Regulations.

Further details of the Regulations are set out in the Attachment.

The Regulations commenced on 1 July 1997.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

1.       Commencement

Regulation 1 provides that the changes contained in these Regulations are to commence on 1 July 1997.

2.       Amendment

Regulation 2 states the Therapeutic Goods Regulations are amended as set out in these amending Regulations.

3.       Regulation 45 (Waiver or reduction of fees)

Subregulation 3.1 amends Subregulation 45(4A) to increase the rate of the reduced evaluation fees payable by an eligible applicant seeking to register a therapeutic device. These reduced fees apply for the evaluation of various aspects of therapeutic devices, such as biocompatibility pre-clinical information, manufacturing processes and other matters.

Subregulation 3.2 amends Subregulation 45(9) to increase the rate of reduced evaluation fees payable in certain circumstances. These reduced fees apply where related applications are lodged at the same time by the same sponsor and the information provided to support each application is sufficiently similar to an evaluation of each device to be conducted simultaneously.

Subregulation 3.3 amends Subregulation 45(11) to increase the rate of the reduced application fee payable by sponsors seeking to amend information contained in the register relating to their registered or listed products. The reduced fees only apply where multiple applications to vary information about the sponsor's products are made simultaneously and the information provided is sufficiently similar to enable an evaluation of each product to be undertaken simultaneously.

4.       Regulation 45A (Charges reduced where annual turnover is not more than $56, 000)

Subregulation 4.1 amends Regulation 45A to raise the threshold amount that determines whether a licenced manufacturer qualifies for a reduced annual charge for holding a manufacturing licence. At present a licensed manufacturer is entitled to pay 50 per cent of the annual charge payable for maintaining a manufacturing licence where the wholesale turnover of therapeutic goods is not more than $50,000 in a financial year. Proposed Subregulation 4.1 will increase the $50,000 threshold to $56,000.

5.       Schedule 9 (Fees)

Subregulation 5.1 sets out the table of increases to the fees currently applying under Schedule 9 of the Therapeutic Goods Regulations. These changes have been agreed to by industry and represent the increase to fees that will enable the TGA to recover 75 per cent of its operating costs.

Overview

The Therapeutic Goods Regulations (Amendment) 1997 No. 162 was enacted to amend the Therapeutic Goods Act 1989 by introducing a new range of fees to enable the Therapeutic Goods Administration (TGA) to recover a higher proportion of its operating costs from industry. The Act, introduced in 1991, established a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The TGA, which administers the Act, operates from the Therapeutic Goods Administration Trust Account, established under the Audit Act 1901. The amendments outlined in the Regulations facilitate the TGA in recovering 75 per cent of its operating costs through the collection of application and evaluation fees, inspection fees, and annual charges. These amendments reflect an agreement with industry for the latest increase to apply from 1 July 1997. The Regulations, which commenced on 1 July 1997, provide for the agreed increases to the existing range of fees under Regulation 45 and Schedule 9 of the Regulations.

Scope and Application

The Therapeutic Goods Regulations (Amendment) 1997 No. 162 amends the Therapeutic Goods Regulations 1990 under the Therapeutic Goods Act 1989. The Act applies to therapeutic goods used in or exported from Australia, and it encompasses a broad range of products including medicines, medical devices, blood and tissues. The Act is administered by the Therapeutic Goods Administration (TGA), which operates under the Audit Act 1901. The Regulations set out the fees and charges for processing applications to include therapeutic goods in the Australian Register of Therapeutic Goods and for variations to the information contained in the Register. These amendments, which came into effect on 1 July 1997, introduce increased application, processing, and evaluation fees to enable the TGA to recover 75 per cent of its operating costs from industry. The amendments also adjust the threshold for reduced annual charges for licensed manufacturers, raising it from $50,000 to $56,000. The Regulations provide for a range of fees, including reduced fees for certain types of applications and evaluations, and fees for inspections of manufacturing operations. The amendments to the Regulations were agreed upon with industry, reflecting the TGA's commitment to cost recovery and maintaining a national system of controls over therapeutic goods.

Key Provisions

The Therapeutic Goods Regulations (Amendment) 1997 No. 162 (the Regulations) modifies the Therapeutic Goods Regulations 1990 (Cth) to align with the Therapeutic Goods Act 1989 (the Act). Section 63 of the Act grants the Governor-General the authority to make regulations, and these amendments particularly focus on updating the fees for applications, processing, and evaluation of therapeutic goods (Section 63(2)(h) and (3)(a)). The changes are designed to assist the Therapeutic Goods Administration (TGA) in recovering 75 per cent of its operating costs through fees and charges, as agreed with industry. The new fees are set out in Regulation 45 and Schedule 9 of the Regulations, reflecting the agreed increases to ensure the TGA's financial sustainability. The obligations imposed by these Regulations primarily concern the entities and individuals who submit applications to the TGA for the registration, evaluation, and amendment of therapeutic goods. For example, Regulation 45(4A), as amended, sets the rates for reduced evaluation fees for eligible applicants seeking to register therapeutic devices, and Regulation 45(9) addresses reduced fees for simultaneous applications by the same sponsor. Additionally, the Regulations establish a higher threshold for the reduced annual charges for licensed manufacturers, now set at $56,000 in wholesale turnover, as per Regulation 45A. These amendments ensure that applicants and manufacturers are aware of the applicable fees and conditions under which they can claim reductions. Breaching the obligations set forth in these Regulations can lead to various consequences. While the specific legal sanctions are not detailed in the Regulations, non-compliance with the fee structures or failure to meet the criteria for reduced fees may result in financial penalties or other administrative actions by the TGA. The TGA may also take enforcement actions if fees are not paid in accordance with the prescribed rates, potentially leading to fines or other financial repercussions. However, the exact penalties are not explicitly stated within the Regulations themselves and would likely be outlined in other relevant sections of the Act or related legislation.

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Area of Law
Administrative Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Fees
Regulatory Standards
Catchwords
Waiver or reduction of fees
Threshold amount
Fees

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