Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 3) 2000 NO. 70

STATUTORY RULES 2000 No. 70

Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2000 (No. 3)

The object of the Therapeutic Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, 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.

The Governor-General may, under section 63 of the Act, make regulations for the purposes of the Act. In particular, the Governor-General may, under subsection 63(1) and paragraphs 63(2)(h) and (3)(a), make regulations prescribing a range of fees including 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.

These regulations increase two fees payable under Schedule 9 of the Therapeutic Goods Regulations. The Regulations increase:

*       the application fee payable by sponsors who apply to list their medicines in the Register; and

*       a processing fee payable by persons who apply to vary information about their medicines contained in the Register. This processing fee is not associated with any evaluation of information and data that may support the application, but reflects the administration costs involved in processing the application, making the appropriate changes to information contained in the Register and supporting decisions and actions taken in relation to this activity.

These costs are required to be recovered because the TGA is required to operate on a total cost recovery basis. The increases have been discussed with the peak industry association representing importers, exporters and manufacturers of listable medicines.

Details of the Regulations are set out in the Attachment.

The Regulations commence on 1 July 2000.

ATTACHMENT

Therapeutic Goods Amendment Regulations 2000 (No. 3)

Regulation 1 states that the title of the regulations is the Therapeutic Goods Amendment Regulations 2000 (No. 3 ).

Regulation 2 provides that the regulations commence from 1 July 2000.

Regulation 3 provides that the regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedule 1.

SCHEDULE 1 - AMENDMENTS

Item 1 increases the fees payable for lodging an application to list medicines in the Australian Register of Therapeutic Goods (the Register) from $270 to $400.

Item 2 increases the processing fee, payable for processing an application seeking to amend information about the applicant's medicine or medicines recorded in the Register, from $100 to $200. These fees do not cover work associated with evaluating information or data that may be lodged to support certain changes being sought.