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Therapeutic Goods Amendment Regulations 2008 (No. 1)

Authoritative Version
  • - F2008L01367
  • No longer in force
SLI 2008 No. 117 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to increase, by 3.6 per cent, most fees to evaluate or amend the details of medicines which are required to be included on the Register. Certain specified fees increase by 10 per cent to curtail continuing under recovery of costs from industry fees over recent years.
Administered by: Health
Registered 20 Jun 2008
Tabling HistoryDate
Tabled HR23-Jun-2008
Tabled Senate24-Jun-2008
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2008 (No. 1)1

Select Legislative Instrument 2008 No. 117

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 19 June 2008

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

JAN McLUCAS


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2008 (No. 1).

2              Commencement

                These Regulations commence on 1 July 2008.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

  

[1]           Subregulation 45 (9)

omit each mention of

$3 970

insert

$4 110

[2]           Subregulation 45 (11)

omit each mention of

$1 460

insert

$1 510

[3]           Regulation 45A, heading

substitute

45A         Charges reduced if annual turnover is not more than $73 600

[4]           Further amendments

 

Provision

omit

insert

Paragraph 45 (4A) (a)

$7 920

$8 210

Paragraph 45 (4A) (b), (c) and (ca)

$6 600

$6 840

Paragraph 45 (4A) (d)

$26 500

$27 500

Paragraphs 45 (4A) (e) and (f)

$6 600

$6 840

Subregulation 45A (1)

$71 000

$73 600

Schedule 9, Part 2, item 1A

340

350

Schedule 9, Part 2, item 1, paragraph (a)

1 240

1 280

Schedule 9, Part 2, item 1, paragraph (b)

15 300

15 900

Schedule 9, Part 2, item 1, paragraph (c)

13 200

13 700

Schedule 9, Part 2, item 1, paragraph (d)

1 990

2 060

Schedule 9, Part 2, item 2, paragraph (a)

990

1 090

Schedule 9, Part 2, item 2, paragraph (b)

1 050

1 090

Schedule 9, Part 2, item 2, paragraph (ba)

6 880

7 130

Schedule 9, Part 2, item 2, paragraph (c)

3 170

3 280

Schedule 9, Part 2, item 2, paragraph (d)

1 580

1 640

Schedule 9, Part 2, item 2, paragraph (d)

$9 220

$9 550

Schedule 9, Part 2, item 2, paragraph (f)

440

480

Schedule 9, Part 2, item 2, paragraph (g)

1 050

1 090

Schedule 9, Part 2, item 2, paragraph (h)

540

560

Schedule 9, Part 2, item 2AA

480

500

Schedule 9, Part 2, item 2A, paragraph (a)

1 200

1 240

Schedule 9, Part 2, item 2A, paragraph (b)

990

1 090

Schedule 9, Part 2, item 2A, paragraph (c)

270

280

Schedule 9, Part 2, item 2A, paragraphs (d) to (g)

330

340

Schedule 9, Part 2, items 2B and 2C

3 880

4 020

Schedule 9, Part 2, item 3, paragraph (a)

330

340

Schedule 9, Part 2, item 3, paragraph (b)

540

560

Schedule 9, Part 2, item 3AA

480

500

Schedule 9, Part 2, item 4, paragraph (a)

170 200

176 300

Schedule 9, Part 2, item 4, paragraph (b)

101 200

104 800

Schedule 9, Part 2, item 4, paragraph (c)

65 000

67 300

Schedule 9, Part 2, item 4, paragraph (d)

10 700

11 100

Schedule 9, Part 2, item 4, paragraph (e)

3 880

4 020

Schedule 9, Part 2, item 4, paragraph (f)

1 200

1 240

Schedule 9, Part 2, item 4, paragraph (g)

65 900

68 300

Schedule 9, Part 2, item 4, paragraph (h)

3 880

4 020

Schedule 9, Part 2, item 5, paragraph (a) and subparagraph (b) (i)

6 570

7 230

Schedule 9, Part 2, item 5, subparagraph (b) (ii)

8 420

9 260

Schedule 9, Part 2, item 5, subparagraph (b) (iii)

11 500

12 700

Schedule 9, Part 2, item 5, subparagraph (b) (iv)

15 400

16 900

Schedule 9, Part 2, item 5, subparagraph (b) (v)

23 000

25 300

Schedule 9, Part 2, item 5, subparagraph (b) (vi)

30 700

33 800

Schedule 9, Part 2, item 5, subparagraph (b) (vii)

46 000

50 600

Schedule 9, Part 2, item 5, paragraph (c) and subparagraph (d) (i)

2 370

2 610

Schedule 9, Part 2, item 5, subparagraph (d) (ii)

8 420

9 260

Schedule 9, Part 2, item 5, subparagraph (d) (iii)

11 500

12 700

Schedule 9, Part 2, item 5, subparagraph (d) (iv)

15 400

16 900

Schedule 9, Part 2, item 5, subparagraph (d) (v)

23 000

25 300

Schedule 9, Part 2, item 5, subparagraph (d) (vi)

30 700

33 800

Schedule 9, Part 2, item 5, subparagraph (d) (vii)

46 000

50 600

Schedule 9, Part 2, item 5A, paragraphs (a) to (f)

3 970

4 110

Schedule 9, Part 2, item 5B

13 200

13 700

Schedule 9, Part 2, item 6, paragraph (a)

23 300

24 100

Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)

15 800

16 400

Schedule 9, Part 2, item 6, paragraph (d)

26 500

27 500

Schedule 9, Part 2, item 6AA

280

290

Schedule 9, Part 2, item 6AB

500

520

Schedule 9, Part 2, item 6ABA

1 500

1 550

Schedule 9, Part 2, item 6AC

850

880

Schedule 9, Part 2, item 6AD, paragraph (a)

15 800

16 400

Schedule 9, Part 2, item 6AD, paragraph (b)

3 970

4 110

Schedule 9, Part 2, item 6A

1 050

1 090

Schedule 9, Part 2, item 6B

2 650

2 750

Schedule 9, Part 2, item 6C

5 270

5 460

Schedule 9, Part 2, item 6D, paragraph (a)

6 570

7 230

Schedule 9, Part 2, item 6D, paragraph (b)

8 420

9 260

Schedule 9, Part 2, item 6D, paragraph (c)

11 500

12 700

Schedule 9, Part 2, item 6D, paragraph (d)

15 400

16 900

Schedule 9, Part 2, item 6D, paragraph (e)

23 000

25 300

Schedule 9, Part 2, item 6D, paragraph (f)

30 700

33 800

Schedule 9, Part 2, item 6D, paragraph (g)

46 000

50 600

Schedule 9, Part 2, item 7, paragraph (a)

7 920

8 210

Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)

6 600

6 840

Schedule 9, Part 2, item 7, paragraph (d)

26 500

27 500

Schedule 9, Part 2, item 7, paragraph (e)

6 600

6 840

Schedule 9, Part 2, item 7, paragraph (f)

6600

6 840

Schedule 9, Part 2, item 7A, paragraph (a) and subparagraph (b) (i)

6 570

7 230

Schedule 9, Part 2, item 7A, subparagraph (b) (ii)

8 420

9 260

Schedule 9, Part 2, item 7A, subparagraph (b) (iii)

11 500

12 700

Schedule 9, Part 2, item 7A, subparagraph (b) (iv)

15 400

16 900

Schedule 9, Part 2, item 7A, subparagraph (b) (v)

23 000

25 300

Schedule 9, Part 2, item 7A, subparagraph (b) (vi)

30 700

33 800

Schedule 9, Part 2, item 7A, subparagraph (b) (vii)

46 000

50 600

Schedule 9, Part 2, item 7B, paragraph (a) and subparagraph (b) (i)

6 570

7 230

Schedule 9, Part 2, item 7B, subparagraph (b) (ii)

8 420

9 260

Schedule 9, Part 2, item 7B, subparagraph (b) (iii)

11 500

12 700

Schedule 9, Part 2, item 7B, subparagraph (b) (iv)

15 400

16 900

Schedule 9, Part 2, item 7B, subparagraph (b) (v)

23 000

25 300

Schedule 9, Part 2, item 7B, subparagraph (b) (vi)

30 700

33 800

Schedule 9, Part 2, item 7B, subparagraph (b) (vii)

46 000

50 600

Schedule 9, Part 2, item 8

730

760

Schedule 9, Part 2, item 9, paragraph (a)

480

500

Schedule 9, Part 2, item 9, paragraph (b)

980

1 020

Schedule 9, Part 2, item 9AA

480

500

Schedule 9, Part 2, item 9AB

660

680

Schedule 9, Part 2, items 9AC and 9ACA

480

500

Schedule 9, Part 2, item 9AD, paragraph (a)

960

990

Schedule 9, Part 2, item 9AD, paragraph (b)

8 200

8 500

Schedule 9, Part 2, item 9AD, paragraph (c)

18 200

18 900

Schedule 9, Part 2, item 9AD, paragraph (d)

24 500

25 400

Schedule 9, Part 2, item 9AD, paragraph (e)

38 300

39 700

Schedule 9, Part 2, item 9AD, paragraph (f)

50 900

52 700

Schedule 9, Part 2, item 9AD, paragraph (g)

62 000

64 200

Schedule 9, Part 2, items 9B and 9C

13 200

13 700

Schedule 9, Part 2, items 14 and 14A

250

260

Schedule 9, Part 2, item 17, subparagraph (a) (i)

170

180

Schedule 9, Part 2, item 17, subparagraph (a) (ii)

210

220

Schedule 9, Part 2, item 17, subparagraph (a) (iii)

340

350

Schedule 9, Part 2, item 17, paragraph (b)

$150

$160

Schedule 9, Part 2, item 17A, subparagraph (a) (i)

870

900

Schedule 9, Part 2, item 17A, subparagraph (a) (ii)

450

470

Schedule 9, Part 2, item 17A, sub‑subparagraph (a) (iii) (A)

660

680

Schedule 9, Part 2, item 17A, sub‑subparagraph (a) (iii) (B)

180

190

Schedule 9, Part 2, item 17A, subparagraph (a) (iv)

320

330

Schedule 9, Part 2, item 17A, subparagraph (a) (v)

220

230

Schedule 9, Part 2, item 17A, sub‑subparagraph (a) (vi) (A)

170

180

Schedule 9, Part 2, item 17A, sub‑subparagraph (a) (vi) (B)

210

220

Schedule 9, Part 2, item 17A, sub‑subparagraph (a) (vi) (C)

340

350

Schedule 9, Part 2, item 17A, paragraph (b)

$150

$160

Schedule 9, Part 2, item 18

1 560

1 620

 


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.