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Therapeutic Goods Amendment Regulations 2002 (No. 3)

Authoritative Version
  • - F2002B00137
  • No longer in force
SR 2002 No. 143 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990.
Administered by: Health
General Comments: This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003
Registered 01 Jan 2005
Tabling HistoryDate
Tabled HR19-Aug-2002
Tabled Senate19-Aug-2002
Gazetted 27 Jun 2002
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2002 (No. 3)1

Statutory Rules 2002 No. 1432

I, PETER JOHN HOLLINGWORTH, 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 26 June 2002

PETER HOLLINGWORTH

Governor-General

By His Excellency’s Command

TRISH WORTH


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2002 (No. 3).

2              Commencement

                These Regulations commence on 1 July 2002.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

  

[1]           Schedule 3, Part 2, after item 7

insert

8

control material for use with diagnostic goods for in vitro use

[2]           Schedule 9, item 2, column 2

omit

application to which item 2AA applies):

insert

application to which item 2AA or 3A applies):

[3]           Schedule 9, after item 3AA

insert

3A

Application fee for paragraph 23 (2) (a) of the Act for registration of a therapeutic device to which item 5 of Part 1 of Schedule 3 applies (if the application is not an application to which item 2AA applies)

The fee applicable under paragraph 2 (c) or (d) for an application of that nature

3B

Evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation is for:

 

 

   (a)  the device

The fee applicable under item 6 for an evaluation of that nature

 

  (b)  a document setting out animal toxicological information about the medicinal component of the device

The fee applicable under paragraph 4 (b) for an evaluation of that nature

 

   (c)  a document setting out the chemistry, quality control and manufacturing information of the medicinal component of the device

The fee applicable under paragraph 4 (c) for an evaluation of that nature

[4]           Schedule 9, item 5A, after paragraph (e)

insert

 

   (f)  control material for use with diagnostic goods for in vitro use

3 400

[5]           Schedule 9, item 6, column 2

omit

in respect of a therapeutic device to which Part 1 of Schedule 3 applies

insert

in respect of a therapeutic device to which any of items 1
to 4 of Part 1 of Schedule 3 applies

[6]           Schedule 9, item 7, column 2

omit

a change to a therapeutic device to which Part 1 of Schedule 3 applies where the evaluation

insert

a change to a therapeutic device to which any of items 1 to 4 of Part 1 of Schedule 3 applies, if the evaluation

[7]           Schedule 9, after item 7

insert

7AA

Fee for evaluation of data submitted in support of a change to a therapeutic device to which item 5 of Part 1 of Schedule 3 applies, if the evaluation involves review of:

 

 

   (a)  the device (not including the medicinal component of the device)

The fee applicable under item 7 for an evaluation of that nature

 

  (b)  the medicinal component of the device

The fee applicable under paragraphs 4 (b), 4 (c) and 7 (d) for an evaluation of that nature

 

   (c)  the device (including the medicinal component of the device)

The fee applicable under paragraphs 4 (b) and 4 (c), and item 7, for an evaluation of that nature

[8]           Schedule 9, item 9A

omit

[9]           Schedule 9, item 15

omit

[10]         Further amendments — regulation 45

 

Provision

omit

insert

Paragraph (4A) (a)

$6 000

$6 800

Paragraphs (4A) (b), (c) and (ca)

$5 000

$5 670

Paragraph (4A) (d)

$20 000

$22 670

Paragraphs (4A) (e) and (f)

$5 000

$5 670

Paragraphs (9) (a), (b), (c), (ca), (d) and (e)

$3 000

$3 400

Paragraphs (11) (a), (b), (c), (ca), (d) and (e)

$1 000

$1 140

[11]         Further amendments — Schedule 9, column 3

 

Provision

omit

insert

Item 1A

260

280

Item 1, paragraph (a)

1 170

1 240

Item 1, paragraph (b)

14 390

15 300

Item 1, paragraph (c)

10 660

11 330

Item 1, paragraph (d)

1 600

1 700

Item 2, paragraph (a)

690

730

Item 2, paragraph (b)

850

900

Item 2, paragraph (ba)

5 330

5 670

Item 2, paragraph (c)

2 560

2 720

Item 2, paragraph (d)

1 280

1 360

Item 2, paragraph (d)

7 460

7 930

Item 2, paragraph (f)

290

310

Item 2, paragraph (g)

850

900

Item 2, paragraph (h)

430

460

Item 2AA

580

620

Item 2A, paragraph (a)

530

560

Item 2A, paragraph (b)

690

730

Item 2A, paragraph (c)

210

220

Item 2A, paragraph (d)

430

460

Item 2A, paragraph (e)

850

900

Item 2A, paragraph (f)

260

280

Item 3, paragraph (a)

260

280

Item 3, paragraph (b)

430

460

Item 3AA

290

310

Item 4, subparagraph (a) (i)

5 760

6 120

Item 4, subparagraph (a) (ii)

17 590

18 700

Item 4, subparagraph (a) (iii)

42 110

44 770

Item 4, subparagraph (a) (iv)

77 290

82 170

Item 4, subparagraph (a) (v)

88 480

94 070

Item 4, subparagraph (a) (vi)

94 340

100 300

Item 4, subparagraph (a) (vii)

99 670

105 960

Item 4, subparagraph (b) (i)

3 330

3 540

Item 4, subparagraph (b) (ii)

11 350

12 070

Item 4, subparagraph (b) (iii)

41 040

43 630

Item 4, subparagraph (b) (iv)

60 760

64 600

Item 4, subparagraph (b) (v)

66 630

70 840

Item 4, subparagraph (b) (vi)

71 960

76 500

Item 4, subparagraph (c) (i)

770

820

Item 4, subparagraph (c) (ii)

6 610

7 030

Item 4, subparagraph (c) (iii)

14 660

15 590

Item 4, subparagraph (c) (iv)

19 720

20 970

Item 4, subparagraph (c) (v)

30 910

32 860

Item 4, subparagraph (c) (vi)

41 040

43 630

Item 4, subparagraph (c) (vii)

50 100

53 260

Item 5, paragraph (a)

4 580

4 870

Item 5, subparagraph (b) (i)

4 580

4 870

Item 5, subparagraph (b) (ii)

5 860

6 230

Item 5, subparagraph (b) (iii)

8 000

8 510

Item 5, subparagraph (b) (iv)

10 660

11 330

Item 5, subparagraph (b) (v)

15 990

17 000

Item 5, subparagraph (b) (vi)

21 320

22 670

Item 5, subparagraph (b) (vii)

31 980

34 000

Item 5, paragraph (c)

1 650

1 750

Item 5, subparagraph (d) (i)

1 650

1 750

Item 5, subparagraph (d) (ii)

5 860

6 230

Item 5, subparagraph (d) (iii)

8 000

8 510

Item 5, subparagraph (d) (iv)

10 660

11 330

Item 5, subparagraph (d) (v)

15 990

17 000

Item 5, subparagraph (d) (vi)

21 320

22 670

Item 5, subparagraph (d) (vii)

31 980

34 000

Item 5A, paragraphs (a), (b), (c), (d) and (e)

3 200

3 400

Item 5B

10 660

11 330

Item 6, paragraph (a)

18 760

19 950

Item 6, paragraphs (b), (c) and (ca)

12 790

13 600

Item 6, paragraph (d)

21 320

22 670

Items 6AA and 6AB

180

190

Item 6AC, paragraph (a)

12 790

13 600

Item 6AC, paragraph (b)

3 200

3 400

Item 6A

850

900

Item 6B

2 130

2 270

Item 6C

4 260

4 530

Item 7, paragraph (a)

6 400

6 800

Item 7, paragraphs (b), (c) and (ca)

5 330

5 670

Item 7, paragraph (d)

21 320

22 670

Item 7, paragraphs (e) and (f)

5 330

5 670

Item 7A, paragraph (a)

4 580

4 870

Item 7A, subparagraph (b) (i)

4 580

4 870

Item 7A, subparagraph (b) (ii)

5 860

6 230

Item 7A, subparagraph (b) (iii)

8 000

8 510

Item 7A, subparagraph (b) (iv)

10 660

11 330

Item 7A, subparagraph (b) (v)

15 990

17 000

Item 7A, subparagraph (b) (vi)

21 320

22 670

Item 7A, subparagraph (b) (vii)

31 980

34 000

Item 7B, paragraph (a)

4 580

4 870

Item 7B, subparagraph (b) (i)

4 580

4 870

Item 7B, subparagraph (b) (ii)

5 860

6 230

Item 7B, subparagraph (b) (iii)

8 000

8 510

Item 7B, subparagraph (b) (iv)

10 660

11 330

Item 7B, subparagraph (b) (v)

15 990

17 000

Item 7B, subparagraph (b) (vi)

21 320

22 670

Item 7B, subparagraph (b) (vii)

31 980

34 000

Item 8

580

620

Item 9, paragraph (a)

380

400

Item 9, paragraph (b)

790

840

Item 9AB

530

560

Item 9AC

380

400

Item 9AD, paragraph (a)

770

820

Item 9AD, paragraph (b)

6 610

7 030

Item 9AD, paragraph (c)

14 660

15 590

Item 9AD, paragraph (d)

19 720

20 970

Item 9AD, paragraph (e)

30 910

32 860

Item 9AD, paragraph (f)

41 040

43 630

Item 9AD, paragraph (g)

50 100

53 260

Item 9B

4 260

4 530

Item 10

70

150

Items 14 and 14A

210

220

Notes

1.       These Regulations amend Statutory Rules 1990 No. 394, as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84 and 114.

2.       Notified in the Commonwealth of Australia Gazette on 27 June 2002.