Commonwealth Numbered Regulations - Explanatory Statements

[Index] [Search] [Download] [Related Items] [Help]


THERAPEUTIC GOODS AMENDMENT REGULATIONS 2009 (NO. 4) (SLI NO 179 OF 2009)

EXPLANATORY STATEMENT

 

Select Legislative Instrument 2009 No. 179

 

Therapeutic Goods Act 1989

 

Therapeutic Goods Amendment Regulations 2009 (No. 4)

 

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.

 

Paragraph 63(2)(h) of the Act provides that the regulations may prescribe fees in respect of matters under the Act or the regulations. Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990 (the Principal Regulations) sets out the table of fees payable under the Act.

 

Paragraph 63(3)(b) of the Act provides that the regulations may also provide for the refund, reduction or waiving of fees and charges in cases identified in the regulations. Regulation 45 of the Principal Regulations provides that the Secretary of the Department of Health and Ageing may waive or reduce fees specified in Schedule 9 to specified amounts under certain circumstances.

 

The purpose of the Regulations is to increase most fees for medicines and medical devices which are required to be listed or registered on the Australian Register of Therapeutic Goods (the Register) by 4.3 per cent, except for certain (specified) fees where the increases are greater to curtail continuing under recovery of costs from industry fees over recent years, specifically:

·      most registered prescription medicines fees increase by 6.6 per cent;

·      Clinical Trial Notification (CTN) fees (notifications referred to in Part 2 of Schedule 9 of the Principal Regulations) increase by 4.3 per cent only: [specifically item(s) 14 and 14A] increase by 4.3 per cent as the fees apply to medicines and medical devices;

·      registered non-prescription medicines fees increase by 13.3 per cent;

·      most listed non-prescription medicines fees increase by 14.3 per cent;

·      fees for the issuance of certificates (certificates referred to in Part 2 of Schedule 9 of the Principal Regulations) increase by 4.3 per cent only: [specifically item 10] increase by 4.3 per cent as the fees apply to medicines and medical devices;

·      medical devices fees increase by 4.3 per cent;

·      blood, blood components and human tissues fees (fees referred to in Part 2 of Schedule 9 of the Principal Regulations) increase by 4.3 per cent only: [specifically item(s) 9AA, 9AB, 9AC, and 9ACA] increase by 4.3 per cent because the level of work effort required (for example audit and on site inspection) is comparable to the work effort required for medicines and medical devices; and

·      manufacturing assessment fees increase by 4.3 per cent.

The new fees have been rounded to the nearest ten dollars (for amounts less than ten thousand dollars) or one hundred dollars (for amounts greater than ten thousand dollars). As a result of the TGA’s rounding policy, the fees for approval of advertisements (fees referred to in Part 2 of Schedule 9 of the Principal Regulations) will remain unchanged at $90.

When taken together with the amendments to the Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 (which are the subject of separate Regulations), it is expected to increase the fees and charges collected by the TGA by $8.8 million (to $99.9 million) over the 2009-10 financial year.

 

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

 

Details of those Regulations are set out in Attachment A.

 

Consultations with industry associations and consumer health representatives on the TGA’s draft Business Plan, Budget and proposed Schedule of Fees and Charges were convened at the TGA Industry Consultative Committee meeting on 3 March 2009. The proposals for fees and annual charges were subject to additional bilateral consultation at sectoral bilateral meetings convened between 16 and 19 March 2009.

 

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

 

The Regulations commence on 10 July 2009.

 

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

 

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989


 

ATTACHMENT A

 

Details of the Therapeutic Goods Amendment

Regulations 2009 (No. 4)

 

Regulation 1 provides for the Regulations to be referred to as the Therapeutic Goods Amendment Regulations 2009 (No. 4).

 

Regulation 2 provides for the Regulations to commence on 10 July 2009.

 

Regulation 3 provides for Schedule 1 to amend the Therapeutic Goods Regulations 1990 (the Principal Regulations).

 

Schedule 1 – Amendments

 

Item [1]

Subregulation 45A(1) of the Principal Regulations currently provides that the annual charges payable for a licence under the Act are reduced if the wholesale turnover of therapeutic goods in a financial year in relation to the person is less than $73,600. Item [9] (below) amends subregulation 45A(1) to increase this threshold by 4.3 per cent (subject to the TGA’s rounding policy) from $73,600 to $76,800. Accordingly, this item amends the heading of Regulation 45A to reflect this increase.

 

Item [2]

This item increases various fees in paragraphs and items 1A, 1(c), 1(d), 2(b), 2(c), 2(d), 2(g), 2(h), 2AA, 2A(d) to 2(g) and 3(a) in Part 2 of Schedule 9 to the Principal Regulations by approximately 4.3 per cent subject to the TGA’s rounding policy.

 

This item increases specified registered prescription medicines fees in paragraphs and items 1(a)-(b), 2A(a), 2B, and 2C of Part 2 of Schedule 9 by 6.6 per cent to curtail under-recovery of costs from industry fees over recent years.

 

This item increases specified registered non prescription medicines fees in paragraphs and items 2(a), 2(f), and 2A(b) of Part 2 of Schedule 9 by 13.3 per cent to curtail continuing under-recovery of costs from industry fees over recent years.

 

This item increases specified listed non prescription medicines fees in paragraphs and items 2A(c) and 3(b) of Part 2 of Schedule 9 by 14.3 per cent to curtail under-recovery of costs from industry over recent years.

 

Paragraph 2(ba) of Part 2, Schedule 9 currently provides that the prescribed fee payable for an application to register certain medicines:

 

·        where the Secretary of the Department of Health and Ageing considers that the application cannot be determined because of the insufficiency of information delivered by the applicant; or

·        if the application is withdrawn before notification of acceptance of the application is sent by the Secretary;

 

is the lesser of 20 per cent of the relevant fee or $7,130.


This item increases the amount of $7,130 in paragraph 2(ba) of Part 2 of Schedule 9 by 6.6 per cent (subject to the TGA’s rounding policy) to $7,600 to curtail under-recovery of costs from industry fees over recent years.

 

Item [3]

This item increases the application fee for reinstatement of a listed product in paragraph 3AA of Part 2 of Schedule 9 by 4.3 per cent.

 

Item [4]

This item increases various fees, in paragraphs and items 5A(a) to 5(f), 5B, 6(a) to (c), 6(ca), 6(d), 6AA, 6AB, 6ABA, 6AC, 6AD(a) to (b), 6A, 6B, 7(a) to (c), 7(ca), and 7(d) to 7(f) in Part 2 of Schedule 9 by approximately 4.3 per cent subject to the TGA’s rounding policy.

 

This item increases specified registered prescription medicines fees, in paragraphs and items 4(a) to (h) of Part 2 of Schedule 9 by 6.6 per cent to curtail under-recovery of costs from industry fees over recent years.

 

This item increases specified registered non prescription medicines fees, in paragraphs and items 5(a), 5(b)(i) to 5(b)(vii), 5(c), 5(d)(i) to 5(d)(vii) and 6D(a) to 6D(g) of Part 2 of Schedule 9 by 13.3 per cent to curtail continuing under-recovery of costs from industry fees over recent years.

 

This item increases specified listed non prescription medicines fees, in paragraph 6C of Part 2 of Schedule 9 by 14.3 per cent to curtail under-recovery of costs from industry over recent years.

 

Item [5]

This item increases various fees, in paragraphs and items 8, 9(a), 9(b), 9AA, 9AB, 9AC, 9ACA, 9AD(a) to 9AD(g), 9B and 9C in Part 2 of Schedule 9 by approximately 4.3 per cent subject to the TGA’s rounding policy.

 

This item increases specified listed non prescription medicines fees, in paragraph 7A(a), 7A(b)(i) to 7A(b)(vii), 7B(a), 7B(b)(i) to 7B(b)(vii) of Part 2 of Schedule 9 by 14.3 per cent to curtail under-recovery of costs from industry over recent years.

 

Item [6]

This item increases the fee for issuance of certificates [certificates issued under paragraph 58 (3) (a) of the Act] in paragraph 10 of Part 2 of Schedule 9 by approximately 4.3 per cent.

 

Item [7]

This item increases the fees for notification to sponsor a clinical trial using a specified medicine or therapeutic device, in paragraphs and items 14 and 14A of Part 2 of Schedule 9 by approximately 4.3 per cent.

 

Item [8]

This item increases the fees for approvals of advertisements, in paragraphs and items 17(a)(i) to 17(a)(iii), 17(b), 17A(a)(i) to 17A(a)(ii), 17A(iii)(A) to 17A(iii)(B), 17A(a)(iv) to 17A(a)(v), 17A(a)(vi)(A) to 17A(a)(vi)(C), and 17A(b) of Part 2 of Schedule 9 by approximately 4.3 per cent.

 

The fees for approval of advertisements [for applications made under Schedule 9, Part 2, Items 17(a)(iv) and 17(c) of the Principal Regulations] will remain unchanged at $90 due to rounding.

 

Item [9]

This item increases the fees applicable, respectively, in subregulations 45(4A), 45(9), 45(11) and 45A(1) of the Principal Regulations, by approximately 4.3 per cent subject to the TGA’s rounding policy.

 

 

 

 


[Index] [Related Items] [Search] [Download] [Help]