Therapeutic Goods Amendment Regulations 2002 (No. 3) (Cth)

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

Parliamentary Secretary to the Minister for Health and Ageing

1Name of Regulations

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

2Commencement

 These Regulations commence on 1 July 2002.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

(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