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Therapeutic Goods Amendment Regulations 2007 (No. 1)

Authoritative Version
  • - F2007L01521
  • No longer in force
SLI 2007 No. 161 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to increase most fees under the Act by 4.0 per cent, introduce a new desk audit fee for assessing overseas manufacturing compliance and vary certain specified fees.
Administered by: Health
Registered 25 Jun 2007
Tabling HistoryDate
Tabled HR07-Aug-2007
Tabled Senate07-Aug-2007
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2007 (No. 1)1

Select Legislative Instrument 2007 No. 161

I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 21 June 2007

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

BRETT MASON

1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2007 (No. 1).

2              Commencement

                These Regulations commence on 1 July 2007.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1        Amendments

(regulation 3)

  

[1]           Regulation 45 — amendment of fees

 

Provision

omit

insert

Paragraph 45 (4A) (a)

$7 620;

$7 920;

Paragraphs 45 (4A) (b), (c) and (ca)

$6 350;

$6 600;

Paragraph 45 (4A) (d)

$25 500;

$26 500;

Paragraph 45 (4A) (e)

$6 350;

$6 600;

Paragraph 45 (4A) (f)

$6 350.

$6 600.

Paragraphs 45 (9) (a) to (d)

$3 820;

$3 970;

Paragraphs 45 (9) (e)

$3 820.

$3 970.

Paragraphs 45 (11) (a) to (d)

$1 400;

$1 460;

Paragraph 45 (11) (e)

$1 400.

$1 460.

[2]           Regulation 45A, heading

substitute

45A         Charges reduced if annual turnover is not more than $71 000

[3]           Subregulation 45A (1)

omit

$68 300

insert

$71 000

[4]           Schedule 9, Part 2, item 6AA

omit

evaluation

insert

processing

[5]           Schedule 9, Part 2, after item 6AB

insert

6ABA

Fee for desk audit of overseas compliance certification to identify third party certifications and review the overseas compliance certification by examining the underlying audit report and obtaining information from the overseas regulators

1 500

[6]           Schedule 9, Part 2, item 6AC

omit

item 6AA

insert

items 6AA and 6ABA

[7]           Schedule 9, Part 2 — amendment of fees

 

Provision

omit

insert

Item 1A

330

340

Item 1, paragraph (c)

12 700

13 200

Item 1, paragraph (d)

1 910

1 990

Item 2, paragraph (a)

950

990

Item 2, paragraph (b)

1 010

1 050

Item 2, paragraph (ba)

6 620;

6 880;

Item 2, paragraph (c)

3 050

3 170

Item 2, paragraph (d)

1 520

1 580

Item 2, paragraph (d)

$8 870

$9 220

Item 2, paragraph (f)

420

440

Item 2, paragraph (g)

1 010

1 050

Item 2, paragraph (h)

520

540

Item 2AA

700

480

Item 2A, paragraph (a)

1 250

1 200

Item 2A, paragraph (b)

950

990

Item 2A, paragraph (c)

260

270

Item 2A, paragraph (d)

520

330

Item 2A, paragraph (e)

1 010

330

Item 2A, paragraphs (f) and (g)

310

330

Items 2B and 2C

4 230

3 880

Item 3, paragraph (a)

310

330

Item 3, paragraph (b)

520

540

Item 3AA

360

480

Item 4, paragraph (a)

178 000

170 200

Item 4, paragraph (b)

105 800

101 200

Item 4, paragraph (d)

11 200

10 700

Item 4, paragraph (e)

4 060

3 880

Item 4, paragraph (f)

1 250

1 200

Item 4, paragraph (g)

69 000

65 900

Item 4, paragraph (h)

4 230

3 880

Item 5, paragraph (a)

6 320

6 570

Item 5, subparagraph (b) (i)

6 320

6 570

Item 5, subparagraph (b) (ii)

8 100

8 420

Item 5, subparagraph (b) (iii)

11 100

11 500

Item 5, subparagraph (b) (iv)

14 800

15 400

Item 5, subparagraph (b) (v)

22 100

23 000

Item 5, subparagraph (b) (vi)

29 500

30 700

Item 5, subparagraph (b) (vii)

44 200

46 000

Item 5, paragraph (c)

2 280

2 370

Item 5, subparagraph (d) (i)

2 280

2 370

Item 5, subparagraph (d) (ii)

8 100

8 420

Item 5, subparagraph (d) (iii)

11 100

11 500

Item 5, subparagraph (d) (iv)

14 800

15 400

Item 5, subparagraph (d) (v)

22 100

23 000

Item 5, subparagraph (d) (vi)

29 500

30 700

Item 5, subparagraph (d) (vii)

44 200

46 000

Item 5A, paragraphs (a) to (f)

3 820

3 970

Item 5B

12 700

13 200

Item 6, paragraph (a)

22 400

23 300

Item 6, paragraphs (b), (c) and (ca)

15 200

15 800

Item 6, paragraph (d)

25 500

26 500

Item 6AA

270

280

Item 6AB

480

500

Item 6AC

820

850

Item 6AD, paragraph (a)

15 200

15 800

Item 6AD, paragraph (b)

3 820

3 970

Item 6A

1 010

1 050

Item 6B

2 550

2 650

Item 6C

5 070

5 270

Item 6D, paragraph (a)

6 320

6 570

Item 6D, paragraph (b)

8 100

8 420

Item 6D, paragraph (c)

11 100

11 500

Item 6D, paragraph (d)

14 800

15 400

Item 6D, paragraph (e)

22 100

23 000

Item 6D, paragraph (f)

29 500

30 700

Item 6D, paragraph (g)

44 200

46 000

Item 7, paragraph (a)

7 620

7 920

Item 7, paragraphs (b), (c) and (ca)

6 350

6 600

Item 7, paragraph (d)

25 500

26 500

Item 7, paragraphs (e) and (f)

6 350

6 600

Item 7A, paragraph (a)

6 320

6 570

Item 7A, subparagraph (b) (i)

6 320

6 570

Item 7A, subparagraph (b) (ii)

8 100

8 420

Item 7A, subparagraph (b) (iii)

11 100

11 500

Item 7A, subparagraph (b) (iv)

14 800

15 400

Item 7A, subparagraph (b) (v)

22 100

23 000

Item 7A, subparagraph (b) (vi)

29 500

30 700

Item 7A, subparagraph (b) (vii)

44 200

46 000

Item 7B, paragraph (a)

6 320

6 570

Item 7B, subparagraph (b) (i)

6 320

6 570

Item 7B, subparagraph (b) (ii)

8 100

8 420

Item 7B, subparagraph (b) (iii)

11 100

11 500

Item 7B, subparagraph (b) (iv)

14 800

15 400

Item 7B, subparagraph (b) (v)

22 100

23 000

Item 7B, subparagraph (b) (vi)

29 500

30 700

Item 7B, subparagraph (b) (vii)

44 200

46 000

Item 8

700

730

Item 9, paragraph (a)

460

480

Item 9, paragraph (b)

940

980

Item 9AA

460

480

Item 9AB

630

660

Items 9AC and 9ACA

460

480

Item 9AD, paragraph (a)

920

960

Item 9AD, paragraph (b)

7 880

8 200

Item 9AD, paragraph (c)

17 500

18 200

Item 9AD, paragraph (d)

23 600

24 500

Item 9AD, paragraph (e)

36 800

38 300

Item 9AD, paragraph (f)

48 900

50 900

Item 9AD, paragraph (g)

59 600

62 000

Items 9B and 9C

12 700

13 200

Item 10

110

120

Items 14 and 14A

240

250

Item 17, subparagraph (a) (i)

160

170

Item 17, subparagraph (a) (ii)

200

210

Item 17, subparagraph (a) (iii)

330

340

Item 17, paragraph (b)

$140

$150

Item 17A, subparagraph (a) (i)

840

870

Item 17A, subparagraph (a) (ii)

430

450

Item 17A, sub‑subparagraph (a) (iii) (A)

630

660

Item 17A, sub‑subparagraph (a) (iii) (B)

170

180

Item 17A, subparagraph (a) (iv)

310

320

Item 17A, subparagraph (a) (v)

210

220

Item 17A, sub‑subparagraph (a) (vi) (A)

160

170

Item 17A, sub‑subparagraph (a) (vi) (B)

200

210

Item 17A, sub‑subparagraph (a) (vi) (C)

330

340

Item 17A, paragraph (b)

$140

$150

Item 18

1 500

1 560

Note

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