Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 131

EXPLANATORY STATEMENT

STATUTORY RULES 1996 No. 131

Issued by Authority of the Minister for Health and Family Services

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 (the Act) has for its objective 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 46 of the Act. TGA is required to operate on a 50 per rent cost-recovery basis, with funding raised through fees and charges collected from industry. Agreement was reached with industry to achieve the goal of 50 per cent cost-recovery for TGA by introducing a series of increases to fees and charges over a four-year period, commencing with the 1993/94 financial year. The last round of increases for the 1996/97 financial year will complete the four-year program designed to enable TGA to meet its cost recovery objective.

Section 83 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 GovernorGeneral 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)(9) 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 proposed Regulations:

(a)       provide for the fourth agreed incremental increase to the existing range of application fees, processing fees and evaluation fees currently applying under Regulation 45 and Schedule 9 of the Regulations;

(b)       introduce a lower fee to be charged for a review of documents or data (which is to include the conduct of computer searches and liaison with overseas agencies) to ascertain whether an overseas manufacturer or the manufacturing steps employed in the overseas manufacture of classes of therapeutic goods imported into Australia are acceptable and would meet Australian standards;

(c)       provide a mechanism for persons who have had their products cancelled from the Register to pay a lower fee to re-list or re-register in the Register their therapeutic goods where such goods have been cancelled from the ARTG for non-payments of the annual charge. This new fee only applies if a sponsor applies to re-list or re-register its product within 30 days of cancellation:

(d)       provide for a higher level of Inspection fees for inspections conducted outside of Australia. These fees are higher than the domestic inspection fees reflecting the greater costs incurred when conducting overseas inspections.

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

The Regulations commence on 1 July 1996.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS REGULATIONS (AMENDMENT)

Regulation 1 provides that the changes contained in these Regulations are to commence on 1 July 1996,

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

Subregulations 3.11, 3.2, 3.3, 3.4 and 3.5 specify the incremental increases to the reduced evaluation fees payable by persons who lodge applications to register therapeutic devices under the Act.

Subregulations 3.6, 3,7, 3.8 and 3.9 specify the incremental increases to the reduced application fees payable by persons who lodge concurrent applications to register similar devices in the Australian Register &Therapeutic Goods (the Register).

Subregulations 3.10, 3.11, 3.12 and 3.13 specify the incremental increases to the reduced application fees payable by persons who lodge concurrent applications to vary particulars in the Register relating to therapeutic devices.

Subregulations 4.11, 4.2, 4.3 and 4.4 inserts new items 2AA and 3AA into Schedule 9 to allow for a reduced application fee that is to be paid by sponsors who have had their product listing or registration cancelled from the Register only because of nonpayment of annual charges and who have re-applied to include their goods in the Register within 30 days of that cancellation.

Subregulation 4.5 Inserts new items 6AA and CAB Into Schedule 9. These items introduce a new fee for the evaluation of data to determine if a step in the manufacture of therapeutic goods carried out outside Australia meets Australian standards, where a person applies to include the imported goods in the Register, or where a person applies to vary information about the imported goods Included in the Register.

Subregulation 4.6 rewrites Item 9 to include new, higher overseas inspection fees for inspections conducted outside Australia. The higher fees reflect the higher costs involved in conducting inspections of overseas manufacturing promises.

Subregulation 4.7 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 fourth and final incremental increase to the fees and charges that have been introduced over a four-year period.