Therapeutic Goods Amendment Regulations 2000 (No. 4)
Statutory Rules 2000 No. 123
I, WILLIAM PATRICK DEANE, 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 2000
WILLIAM DEANE
Governor-General
By His Excellency’s Command
grant tambling
Parliamentary Secretary to the Minister for Health
and Aged Care

Therapeutic Goods Amendment Regulations 2000 (No. 4)1
Statutory Rules 2000 No. 1232
made under the
Therapeutic Goods Act 1989

Contents
	Page
	1	Name of Regulations	2
	2	Commencement	2
	3	Amendment of Therapeutic Goods Regulations 1990	2
Schedule 1	Amendments	3

1	Name of Regulations
		These Regulations are the Therapeutic Goods Amendment Regulations 2000 (No. 4).
2	Commencement
		These Regulations commence on gazettal.
3	Amendment of Therapeutic Goods Regulations 1990
		Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1	Amendments
(regulation 3)
[1]	Paragraph 45 (4A) (a)
omit
$4,800
insert
$6 000
[2]	Paragraph 45 (4A) (b)
omit
$2,795
insert
$5 000
[3]	Paragraph 45 (4A) (c)
substitute
	(c)	in the case of an application involving the evaluation of 1 or both of the following:
	(i)	biocompatability;
	(ii)	pre-clinical information;
		is reduced by $5 000; and
	(ca)	in the case of an application involving the evaluation of software — is reduced to $5 000;
[4]	Paragraph 45 (4A) (d)
omit
$16,800
insert
$20 000
[5]	Paragraph 45 (4A) (e)
omit
$5,640.
insert
$5 000; and
[6]	After paragraph 45 (4A) (e)
insert
	(f)	for an application involving confirmatory evaluation of overseas reports or data lodged to support the application  is $5 000.
[7]	Paragraph 45 (9) (a)
omit
$4,800
insert
$3 000
[8]	Paragraph 45 (9) (b)
omit
$2,795
insert
$3 000
[9]	Paragraph 45 (9) (c)
substitute
	(c)	in the case of an application involving the evaluation of 1 or both of the following:
	(i)	biocompatability;
	(ii)	pre-clinical information;
		is reduced to $3 000; and
	(ca)	in the case of an application involving the evaluation of software  is reduced to $3 000; and
[10]	Paragraph 45 (9) (d)
omit
$5,640.
insert
$3 000; and
[11]	After paragraph 45 (9) (d)
insert
	(e)	in the case of an application involving confirmatory evaluation of overseas reports or data lodged to support the application  is reduced to $3 000.
[12]	Paragraph 45 (11) (a)
omit
$1,610
insert
$1 000
[13]	Paragraph 45 (11) (b)
omit
$960
insert
$1 000
[14]	Paragraph 45 (11) (c)
substitute
	(c)	in the case of an application involving the evaluation of 1 or both of the following:
	(i)	biocompatability;
	(ii)	pre-clinical information;
		is reduced to $1 000; and
	(ca)	in the case of an application involving the evaluation of software — is reduced to $1 000; and
[15]	Paragraph 45 (11) (d)
omit
$5,640.
insert
$1 000; and
[16]	After paragraph 45 (11) (d)
insert
	(e)	in the case of an application involving confirmatory evaluation of overseas reports or data lodged to support the application  is reduced to $1 000.
[17]	Schedule 9, before item 1
insert
1A	application fee for processing an application for consent under section 14 of the Act 	240	
[18]	Schedule 9, item 2, paragraph (c)
after
paragraph (d),
insert
for an application
[19]	Schedule 9, item 2, subparagraph (d) (ii)
omit
made;
insert
made
[20]	Schedule 9, item 2, paragraph (d)
omit
then for each additional application
[21]	Schedule 9, item 2, subparagraph (d) (ii), column 3
omit
890
insert
1 200 — for each additional application, up to a maximum amount payable of $7 000 (including the fee payable under paragraph (c))
[22]	Schedule 9, item 5A
substitute
5A	evaluation fee for subsection 24 (1) of the Act for a therapeutic device to which items 2 to 6 of Part 2, Schedule 3 apply, and that involves the evaluation of:
(a)	design or materials information or testing
(b)	manufacture, quality control or sterile manufacture, or testing information
(c)	biocompatability or preclinical information
(d)	software
(e)	human clinical information	

3 000
3 000

3 000

3 000
3 000	
5B	evaluation fee for subsection 24 (1) of the Act in respect of disinfectants or diagnostic goods for in vitro use	10 000	
[23]	Schedule 9, item 6A
substitute
6A	fee for evaluation of data, under subsection 32 (3), (4) or (5) of the Act, about an entry in the Register relating to a therapeutic device to which items 2 to 6 of Part 2, Schedule 3 apply	800	
6B	fee for evaluation of data, under subsection 32 (3), (4) or (5) of the Act, about an entry in the Register relating to disinfectants and diagnostic goods for in vitro use	2 000	
6C	evaluation fee for assessing information or documents obtained under paragraph 31 (2) (f) of the Act	4 000	
[24]	Schedule 9, item 7, after paragraph (e)
insert
	(f)	confirmatory evaluation of overseas reports or data	5 000	
[25]	Schedule 9, after item 9A
insert
9B	evaluation fee for assessing, for paragraph 26 (1) (d) of the Act, whether a therapeutic device is safe for the purposes for which it is to be used	4 000	
[26]	Schedule 9, item 14A
omit
250
insert
200
[27]	Additional amendments of Schedule 9
Provision	omit	insert	
Item 1, paragraph (c)	9,800	10 000	
Item 1, paragraph (d)	1,125	1 500	
Item 2, paragraph (b)	540	800	
Item 2, paragraph (c)	1,825	2 400	
Item 2, paragraph (g)	540	800	
Item 2, paragraph (h)	300	400	
Item 2A, paragraph (d)	300	400	
Item 2A, paragraph (e)	540	800	
Item 2A, paragraph (f)	300	240	
Item 3, paragraph (a)	300	240	
Item 6, paragraph (a)	14,790	17 600	
Item 6, paragraph (b)	8,400	12 000	
Item 6, paragraph (c)	8,400	12 000	
Item 6, paragraph (ca)	8,400	12 000	
Item 6, paragraph (d)	16,800	20 000	
Item 6AC, paragraph (a)	4,560	12 000	
Item 6AC, paragraph (b)	1,610	3 000	
Item 7, paragraph (a)	4,880	6 000	
Item 7, paragraph (b)	2,850	5 000	
Item 7, paragraph (c)	4,200	5 000	
Item 7, paragraph (ca)	4,200	5 000	
Item 7, paragraph (d)	16,800	20 000	
Item 7, paragraph (e)	5,640	5 000	
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 and 70.
2.	Made by the Governor-General on 21 June 2000, and notified in the Commonwealth of Australia Gazette on 22 June 2000.