Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 NO. 162

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.