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Therapeutic Goods Amendment Regulations 2000 (No. 4)

Authoritative Version
  • - F2000B00130
  • No longer in force
SR 2000 No. 123 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 HR14-Aug-2000
Tabled Senate14-Aug-2000
Gazetted 22 Jun 2000
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

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

 

 

 

Contents

                                                                                                                 Page

                        1  Name of Regulations                                                         2

                        2  Commencement                                                                2

                        3  Amendment of Therapeutic Goods Regulations 1990            2

Schedule 1           Amendments                                                                    3

 


Do not delete : Part placeholder

Do not delete : Division placeholder

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

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.