Therapeutic Goods (Charges) Amendment Regulations 2010 (No. 1)1

Select Legislative Instrument 2010 No. 131

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods (Charges) Act 1989.

Dated 15 June 2010

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

MARK BUTLER

Parliamentary Secretary for Health

1 Name of Regulations

  These Regulations are the Therapeutic Goods (Charges) Amendment Regulations 2010 (No. 1).

2 Commencement

  These Regulations commence on 1 July 2010.

3 Amendment of Therapeutic Goods (Charges) Regulations 1990

  Schedule 1 amends the Therapeutic Goods (Charges) Regulations 1990.

Schedule 1 Amendments

(regulation 3)

 

[1] Paragraph 3 (1B) (d)

omit

 $1 030.

insert

$1 030;

[2] After paragraph 3 (1B) (d)

insert

 (e) for an IVD medical device  — nil.

[3] Subregulation 3 (3), note

substitute

Note   Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3-3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a financial year is not more than $78 600 is half the amount mentioned in subregulation (2) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.

[4] Further amendments

Provision

omit each mention of

insert

Subparagraph 3 (1) (a) (i)

$1 140

$1 170

Subparagraph 3 (1) (a) (ii)

$2 260

$2 310

Subparagraph 3 (1) (a) (iii)

$1 290

$1 320

Subparagraph 3 (1) (b) (i)

$5 600

$5 730

Subparagraph 3 (1) (b) (ii)

$3 350

$3 430

Subparagraph 3 (1) (c) (i)

$810

$830

Subparagraph 3 (1) (c) (ii)

$1 140

$1 170

Subparagraph 3 (1) (c) (iii)

$650

$670

Subparagraph 3 (1A) (a) (i)

$1 140

$1 170

Subparagraph 3 (1A) (a) (ii)

$2 260

$2 310

Subparagraph 3 (1A) (a) (iii)

$1 290

$1 320

Subparagraph 3 (1A) (b) (i)

$5 600

$5 730

Subparagraph 3 (1A) (b) (ii)

$3 350

$3 430

Subparagraph 3 (1A) (c) (i)

$810

$830

Subparagraph 3 (1A) (c) (ii)

$1 140

$1 170

Subparagraph 3 (1A) (c) (iii)

$650

$670

Paragraph 3 (1B) (b)

$520

$530

Paragraph 3 (1B) (c)

$790

$810

Paragraph 3 (1B) (d)

$1 030

$1 050

Paragraphs 3 (2) (a) and (b)

$9 700

$9 930

Paragraphs 3 (2) (c) to (h)

$5 010

$5 130

Subparagraph 3 (2) (j) (i)

$125 700

$128 700

Subparagraph 3 (2) (j) (ii)

$6 180

$6 330

Paragraphs 3 (2) (ja) and (k)

$5 410

$5 540

Paragraph 3 (2) (l)

$10 500

$10 800

Note

1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.