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 Parliamentary Secretary to the Minister for Health and Ageing
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.