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Therapeutic Goods Amendment Regulations 2005 (No. 1)

Authoritative Version
  • - F2005L02312
  • No longer in force
SLI 2005 No. 192 Regulations as made
These Regulations increase most fees payable under the Therapeutic Goods Act 1989, by 1.6% introduce new fees, vary specified fees and a technical correction to numbering in the Principal Regulations.
Administered by: Health
Registered 19 Aug 2005
Tabling HistoryDate
Tabled HR05-Sep-2005
Tabled Senate05-Sep-2005
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2005 (No. 1)1

Select Legislative Instrument 2005 No. 192

I, PHILIP MICHAEL JEFFERY, 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 18 August 2005

P. M. JEFFERY

Governor-General

By His Excellency’s Command

CHRISTOPHER PYNE


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2005 (No. 1).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

  

[1]           Regulation 3A

omit

                For paragraph 3 (5) (e)

insert

         (1)   For paragraph 3 (5) (e)

[2]           Regulation 3A

insert

         (2)   For paragraph 3 (5) (e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recovery.

[3]           Regulation 6A

substitute

6A           Approval of use of restricted representation — public interest criteria

                For paragraph 42DF (4) (c) of the Act, Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.

[4]           Regulation 45 — amendment of fees

 

Provision

omit

insert

Paragraph 45 (4A) (a)

$7 240;

$7 360;

Paragraphs 45 (4A) (b), (c) and (ca)

$6 040;

$6 140;

Paragraph 45 (4A) (d)

$24 200;

$24 600;

Paragraph 45 (4A) (e)

$6 040;

$6 140;

Paragraph 45 (4A) (f)

$6 040.

$6 140.

Paragraphs 45 (9) (a), (b), (c), (ca) and (d)

$3 630;

$3 690;

Paragraph 45 (9) (e)

$3 630.

$3 690.

Paragraphs 45 (11) (a), (b), (c), (ca) and (d)

$1 330;

$1 350;

Paragraph 45 (11) (e)

$1 330.

$1 350.

[5]           Regulation 45A, heading

substitute

45A         Charges reduced if annual turnover is not more than $66 000

[6]           Subregulation 45A (1)

omit

$65 000

insert

$66 000

[7]           Schedule 9, Part 1, subclause 1 (1), after definition of broadcast media

insert

haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells.

[8]           Schedule 9, Part 2, item 9, paragraph (a), column 2

omit

(except for therapeutic goods mentioned in items 9AB, 9AC and 9ACA),

insert

(except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA),

[9]           Schedule 9, Part 2, after item 9

insert

9AA

fee for inspection (including an inspection for paragraph  58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour

440

[10]         Schedule 9, Part 2, items 9AB and 9AC, column 2

omit

human blood and blood components

insert

human blood and blood components (other than haematopoietic progenitor cells)

[11]         Schedule 9, Part 2, column 3 — amendment of fees

 

Provision

omit

insert

Item 1A

300

310

Item 1, paragraph (c)

12 100

12 300

Item 1, paragraph (d)

1 820

1 850

Item 2, paragraph (a)

780

790

Item 2, paragraph (b)

960

980

Item 2, paragraph (ba)

5 850;

5 950;

Item 2, paragraph (c)

2 900

2 950

Item 2, paragraph (d)

1 450

1 470

Item 2, paragraph (d)

$8 440

$8 580

Item 2, paragraph (f)

340

350

Item 2, paragraph (g)

960

980

Item 2, paragraph (h)

490

500

Item 2AA

670

680

Item 2A, paragraph (b)

780

790

Item 2A, paragraph (c)

240

250

Item 2A, paragraph (d)

490

500

Item 2A, paragraph (e)

960

980

Item 2A, paragraphs (f) and (g)

300

310

Items 2B and 2C

4 280

4 170

Item 3, paragraph (a)

300

310

Item 3, paragraph (b)

490

500

Item 3AA

340

350

Item 4, paragraph (a)

189 900

182 900

Item 4, paragraph (b)

112 900

108 800

Item 4, paragraph (c)

67 000

65 000

Item 4, paragraph (d)

11 900

11 500

Item 4, paragraph (e)

4 280

4 170

Item 4, paragraph (g)

73 600

70 900

Item 4, paragraph (h)

4 280

4 170

Item 5, paragraph (a) and subparagraph (b) (i)

5 190

5 270

Item 5, subparagraph (b) (ii)

6 640

6 750

Item 5, subparagraph (b) (iii)

9 060

9 200

Item 5, subparagraph (b) (iv)

12 060

12 300

Item 5, subparagraph (b) (v)

18 100

18 400

Item 5, subparagraph (b) (vi)

24 200

24 600

Item 5, subparagraph (b) (vii)

36 200

36 800

Item 5, paragraph (c) and subparagraph (d) (i)

1 870

1 900

Item 5, subparagraph (d) (ii)

6 640

6 750

Item 5, subparagraph (d) (iii)

9 060

9 200

Item 5, subparagraph (d) (iv)

12 100

12 300

Item 5, subparagraph (d) (v)

18 100

18 400

Item 5, subparagraph (d) (vi)

24 200

24 600

Item 5, subparagraph (d) (vii)

36 200

36 800

Item 5A, paragraphs (a) to (f)

3 630

3 690

Item 5B

12 100

12 300

Item 6, paragraph (a)

21 300

21 600

Item 6, paragraphs (b), (c) and (ca)

14 500

14 700

Item 6, paragraph (d)

24 200

24 600

Item 6AA

250

260

Item 6AB

220

230

Item 6AC

780

790

Item 6AD, paragraph (a)

14 500

14 700

Item 6AD, paragraph (b)

3 630

3 690

Item 6A

960

980

Item 6B

2 420

2 460

Item 6C

4 830

4 900

Item 6D, paragraph (a)

5 190

5 270

Item 6D, paragraph (b)

6 640

6 750

Item 6D, paragraph (c)

9 060

9 200

Item 6D, paragraph (d)

12 100

12 300

Item 6D, paragraph (e)

18 100

18 400

Item 6D, paragraph (f)

24 200

24 600

Item 6D, paragraph (g)

36 200

36 800

Item 7, paragraph (a)

7 240

7 360

Item 7, paragraphs (b), (c) and (ca)

6 040

6 140

Item 7, paragraph (d)

24 200

24 600

Item 7, paragraphs (e) and (f)

6 040

6 140

Item 7A, paragraph (a) and subparagraph (b) (i)

5 190

5 270

Item 7A, subparagraph (b) (ii)

6 640

6 750

Item 7A, subparagraph (b) (iii)

9 060

9 200

Item 7A, subparagraph (b) (iv)

12 100

12 300

Item 7A, subparagraph (b) (v)

18 100

18 400

Item 7A, subparagraph (b) (vi)

24 200

24 600

Item 7A, subparagraph (b) (vii)

36 200

36 800

Item 7B, paragraph (a) and subparagraph (b) (i)

5 190

5 270

Item 7B, subparagraph (b) (ii)

6 640

6 750

Item 7B, subparagraph (b) (iii)

9 060

9 200

Item 7B, subparagraph (b) (iv)

12 100

12 300

Item 7B, subparagraph (b) (v)

18 100

18 400

Item 7B, subparagraph (b) (vi)

24 200

24 600

Item 7B, subparagraph (b) (vii)

36 200

36 800

Item 8

670

680

Item 9, paragraph (a)

430

440

Item 9, paragraph (b)

900

910

Item 9AB

600

610

Items 9AC and 9ACA

430

440

Item 9AD, paragraph (a)

880

890

Item 9AD, paragraph (b)

7 490

7 610

Item 9AD, paragraph (c)

16 600

16 900

Item 9AD, paragraph (d)

22 400

22 800

Item 9AD, paragraph (e)

35 000

35 600

Item 9AD, paragraph (f)

46 500

47 200

Item 9AD, paragraph (g)

56 700

57 600

Items 9B and 9C

12 100

12 300

Item 10

90

100

Item 17, subparagraph (a) (i)

140

150

Item 17, subparagraph (a) (ii)

180

190

Item 17, subparagraph (a) (iii)

310

320

Item 17, subparagraph (a) (iv)

70

80

Item 17, paragraph (b)

$120

$130

Item 17, paragraph (c)

70

80

Item 17A, subparagraph (a) (i)

800

810

Item 17A, subparagraph (a) (ii)

400

410

Item 17A, sub-subparagraph (a) (iii) (A)

600

610

Item 17A, sub-subparagraph (a) (iii) (B)

150

160

Item 17A, subparagraph (a) (iv)

290

300

Item 17A, subparagraph (a) (v)

190

200

Item 17A, sub-subparagraph (a) (vi) (A)

140

150

Item 17A, sub-subparagraph (a) (vi) (B)

180

190

Item 17A, sub-subparagraph (a) (vi) (C)

310

320

Item 17A, paragraph (b)

$120

$130

Item 18

10 300

10 500

Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.frli.gov.au.