Therapeutic Goods Amendment Regulations 2000 (No. 4) (Cth)

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 theTherapeutic 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

• •
• •

 

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1Name of Regulations

 These Regulations are the Therapeutic Goods Amendment Regulations 2000 (No. 4).

2Commencement

 These Regulations commence on gazettal.

3Amendment of Therapeutic Goods Regulations 1990

Schedule 1 amends the Therapeutic Goods Regulations 1990.

Schedule 1Amendments

Do not delete: Schedule Part placeholder

(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 ¾ 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 ¾ 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 ¾ 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 ¾ 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.