Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013

Link to law: https://www.comlaw.gov.au/Details/F2013L00896

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Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013
 
Select Legislative Instrument No. 94, 2013
I, Professor Marie Bashir AC CVO, Administrator of the Government of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.
Dated 30 May 2013
Marie Bashir
Administrator
By Her Excellency’s Command
Shayne Neumann
Parliamentary Secretary for Health and Ageing
 
 
  
  
Contents
1............ Name of regulation.............................................................................. 1
2............ Commencement................................................................................... 1
3............ Authority............................................................................................. 1
4............ Schedule(s)......................................................................................... 1
Schedule 1—Amendments                                                                                                2
Therapeutic Goods (Charges) Regulations 1990                                                  2
Therapeutic Goods (Medical Devices) Regulations 2002                                   3
Therapeutic Goods Regulations 1990                                                                     4
 
1  Name of regulation
                   This regulation is the Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013.
2  Commencement
                   This regulation commences on 1 July 2013.
3  Authority
                   This regulation is made under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.
4  Schedule(s)
                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
  
Therapeutic Goods (Charges) Regulations 1990
1  Amendments of listed provisions—charges
 
Amendments relating to charges

Item
Provision
Omit
Substitute

1
Subparagraph 3(1)(a)(i)
$1 280
$1 320

2
Subparagraph 3(1)(a)(ii)
$2 520
$2 590

3
Subparagraph 3(1)(a)(iii)
$1 440
$1 480

4
Subparagraph 3(1)(b)(i)
$6 250
$6 430

5
Subparagraph 3(1)(b)(ii)
$3 750
$3 860

6
Subparagraph 3(1)(c)(i)
$910
$940

7
Subparagraph 3(1)(c)(ii)
$1 280
$1 320

8
Subparagraph 3(1)(c)(iii)
$730
$750

9
Subparagraph 3(1A)(a)(i)
$1 280
$1 320

10
Subparagraph 3(1A)(a)(ii)
$2 520
$2 590

11
Subparagraph 3(1A)(a)(iii)
$1 440
$1 480

12
Subparagraph 3(1A)(b)(i)
$6 250
$6 430

13
Subparagraph 3(1A)(b)(ii)
$3 750
$3 860

14
Subparagraph 3(1A)(c)(i)
$910
$940

15
Subparagraph 3(1A)(c)(ii)
$1 280
$1 320

16
Subparagraph 3(1A)(c)(iii)
$730
$750

17
Paragraph 3(1AA)(a)
$580
$600

18
Paragraph 3(1AA)(b)
$5 810
$5 980

19
Paragraph 3(1B)(a)
$70
$80

20
Paragraph 3(1B)(b)
$580
$600

21
Paragraph 3(1B)(c)
$890
$920

22
Paragraph 3(1B)(d)
$1 150
$1 180

23
Paragraphs 3(2)(a) and (b)
$10 900
$11 200

24
Paragraphs 3(2)(c) to (h)
$5 600
$5 760

25
Subparagraph 3(2)(j)(i)
$140 600
$144 700

26
Subparagraph 3(2)(j)(ii)
$6 920
$7 120

27
Paragraphs 3(2)(ja) and (k)
$6 050
$6 230

28
Paragraph 3(2)(l)
$11 800
$12 100

29
Subregulation 3(3), note
$85 900
$88 400

 
Therapeutic Goods (Medical Devices) Regulations 2002
2  Amendments of listed provisions—fees
 
Amendments relating to fees

Item
Provision
Omit
Substitute

1
Paragraph 9.4 (2) (b)
$3 520
$3 620

2
Schedule 5, item 1.1
870
900

3
Schedule 5, item 1.2, paragraph (a)
7 560
7 780

4
Schedule 5, item 1.2, paragraph (b)
7 610
7 830

5
Schedule 5, item 1.3, paragraph (a)
46 400
47 700

6
Schedule 5, item 1.3, paragraph (b)
35 700
36 700

7
Schedule 5, item 1.3A, paragraph (a)
26 100
26 900

8
Schedule 5, item 1.3A, paragraph (b)
55 700
57 300

9
Schedule 5, item 1.3A, paragraph (c)
13 600
14 000

10
Schedule 5, item 1.3A, paragraph (d)
3 280
3 380

11
Schedule 5, item 1.3A, paragraph (e)
36 000
37 000

12
Schedule 5, item 1.3A, paragraph (f)
22 900
23 600

13
Schedule 5, item 1.5, paragraphs (a) and (b)
1 150
1 180

14
Schedule 5, item 1.5, paragraphs (c) to (f)
890
920

15
Schedule 5, item 1.7
15 900
16 400

16
Schedule 5, item 1.8
310
320

17
Schedule 5, item 1.9, paragraph (a)
26 000
26 800

18
Schedule 5, item 1.9, paragraph (b)
51 200
52 700

19
Schedule 5, item 1.9, paragraph (c)
35 700
36 700

20
Schedule 5, item 1.9, paragraph (d)
24 900
25 600

21
Schedule 5, item 1.9, paragraph (e)
22 700
23 400

22
Schedule 5, item 1.9, paragraph (f)
19 400
20 000

23
Schedule 5, item 1.9A, paragraph (a)
26 100
26 900

24
Schedule 5, item 1.9A, paragraph (b)
55 700
57 300

25
Schedule 5, item 1.9A, paragraph (c)
13 600
14 000

26
Schedule 5, item 1.9A, paragraph (d)
3 280
3 380

27
Schedule 5, item 1.9A, paragraph (e)
36 000
37 000

28
Schedule 5, item 1.9A, paragraph (f)
22 900
23 600

29
Schedule 5, item 1.10, paragraph (a)
15 600
16 100

30
Schedule 5, item 1.10, paragraph (b)
30 800
31 700

31
Schedule 5, item 1.10, paragraph (c)
21 500
22 100

32
Schedule 5, item 1.10, paragraph (d)
13 600
14 000

33
Schedule 5, item 1.10, paragraph (e)
11 800
12 100

34
Schedule 5, item 1.12
360
370

35
Schedule 5, item 1.13
3 360
3 460

36
Schedule 5, item 1.14
6 170
6 350

37
Schedule 5, item 1.14A
6 010
6 180

38
Schedule 5, item 1.15
390
400

39
Schedule 5, item 1.17
890
920

40
Schedule 5, paragraph 2.1(b)
$360
$370

 
Therapeutic Goods Regulations 1990
3  Amendments of listed provisions—fees and charges
 
Amendments relating to fees and charges

Item
Provision
Omit
Substitute

1
Paragraph 43AAJ (1)(b)
$85 900
$88 400

2
Paragraph 45(4A)(a)
$9 580
$9 860

3
Paragraph 45(4A)(b)
$7 970
$8 200

4
Paragraphs 45(4A)(c) and (ca)
$7 710
$7 930

5
Paragraph 45(4A)(d)
$32 100
$33 000

6
Paragraphs 45(4A)(e) and (f)
$7 710
$7 930

7
Paragraphs 45(9)(a) to (e)
$4 790
$4 930

8
Paragraphs 45(11)(a) to (e)
$1 750
$1 800

9
Regulation 45A
$14 000
$15 000

10
Schedule 9, Part 2, item 1A
410
420

11
Schedule 9, Part 2, item 1, paragraph (a)
1 520
1 560

12
Schedule 9, Part 2, item 1, paragraph (b)
18 900
19 400

13
Schedule 9, Part 2, item 1, paragraph (c)
15 900
16 400

14
Schedule 9, Part 2, item 1, paragraph (d)
2 400
2 470

15
Schedule 9, Part 2, item 2, paragraph (a)
1 370
1 410

16
Schedule 9, Part 2, item 2, paragraph (b)
1 280
1 320

17
Schedule 9, Part 2, item 2, paragraph (ba)
42 000
43 200

18
Schedule 9, Part 2, item 2, paragraph (bb)
14 000
14 400

19
Schedule 9, Part 2, item 2, paragraph (bc)
28 000
28 800

20
Schedule 9, Part 2, item 2, paragraph (bd)
25 000
25 700

21
Schedule 9, Part 2, item 2, subparagraph (be)(i)
8 330
8 570

22
Schedule 9, Part 2, item 2, subparagraph (be)(ii)
5 430
5 590

23
Schedule 9, Part 2, item 2, subparagraph (bf)(i)
16 700
17 200

24
Schedule 9, Part 2, item 2, subparagraph (bf)(ii)
10 900
11 200

25
Schedule 9, Part 2, item 2, paragraph (bg)
16 100
16 600

26
Schedule 9, Part 2, item 2, paragraph (bh)
2 640
2 720

27
Schedule 9, Part 2, item 2, paragraph (bi)
16 300
16 800

28
Schedule 9, Part 2, item 2, paragraph (bj)
960
990

29
Schedule 9, Part 2, item 2, paragraph (c)
3 820
3 930

30
Schedule 9, Part 2, item 2, paragraph (d)
1 910
1 970

31
Schedule 9, Part 2, item 2, paragraph (d)
11 100
11 400

32
Schedule 9, Part 2, item 2, paragraph (f)
600
620

33
Schedule 9, Part 2, item 2, paragraph (g)
1 280
1 320

34
Schedule 9, Part 2, item 2, paragraph (h)
640
660

35
Schedule 9, Part 2, item 2AA
580
600

36
Schedule 9, Part 2, item 2A, paragraph (a)
1 480
1 520

37
Schedule 9, Part 2, item 2A, paragraph (b)
1 370
1 410

38
Schedule 9, Part 2, item 2A, paragraph (c)
360
370

39
Schedule 9, Part 2, item 2A, paragraphs (d) to (g)
390
400

40
Schedule 9, Part 2, item 2AB
370
380

41
Schedule 9, Part 2, item 2AC
960
990

42
Schedule 9, Part 2, item 2B
4 790
4 930

43
Schedule 9, Part 2, item 2C
3 830
3 940

44
Schedule 9, Part 2, item 2CA
4 790
4 930

45
Schedule 9, Part 2, item 3, paragraph (a)
390
400

46
Schedule 9, Part 2, item 3, paragraph (b)
720
740

47
Schedule 9, Part 2, item 3AA
580
600

48
Schedule 9, Part 2, item 3AB
140
150

49
Schedule 9, Part 2, item 4, paragraph (a)
168 100
173 000

50
Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii)
56 100
57 700

51
Schedule 9, Part 2, item 4, subparagraph (aa)(iii)
112 000
115 200

52
Schedule 9, Part 2, item 4, paragraph (b)
99 900
102 800

53
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(a)
33 300
34 300

54
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(b)
21 600
22 200

55
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(a)
33 300
34 300

56
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(b)
21 600
22 200

57
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(a)
66 600
68 500

58
Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(b)
43 400
44 700

59
Schedule 9, Part 2, item 4, paragraph (c)
64 100
66 000

60
Schedule 9, Part 2, item 4, paragraph (d)
10 600
10 900

61
Schedule 9, Part 2, item 4, paragraph (g)
65 000
66 900

62
Schedule 9, Part 2, item 4, paragraph (h)
3 830
3 940

63
Schedule 9, Part 2, item 5, paragraph (a)
9 170
9 440

64
Schedule 9, Part 2, item 5, subparagraph (b)(i)
9 170
9 440

65
Schedule 9, Part 2, item 5, subparagraph (b)(ii)
11 800
12 100

66
Schedule 9, Part 2, item 5, subparagraph (b)(iii)
16 100
16 600

67
Schedule 9, Part 2, item 5, subparagraph (b)(iv)
21 400
22 000

68
Schedule 9, Part 2, item 5, subparagraph (b)(v)
32 100
33 000

69
Schedule 9, Part 2, item 5, subparagraph (b)(vi)
42 800
44 000

70
Schedule 9, Part 2, item 5, subparagraph (b)(vii)
64 100
66 000

71
Schedule 9, Part 2, item 5, paragraph (c)
3 310
3 410

72
Schedule 9, Part 2, item 5, subparagraph (d)(i)
3 310
3 410

73
Schedule 9, Part 2, item 5, subparagraph (d)(ii)
11 800
12 100

74
Schedule 9, Part 2, item 5, subparagraph (d)(iii)
16 100
16 600

75
Schedule 9, Part 2, item 5, subparagraph (d)(iv)
21 400
22 000

76
Schedule 9, Part 2, item 5, subparagraph (d)(v)
32 100
33 000

77
Schedule 9, Part 2, item 5, subparagraph (d)(vi)
42 800
44 000

78
Schedule 9, Part 2, item 5, subparagraph (d)(vii)
64 100
66 000

79
Schedule 9, Part 2, item 5A, paragraphs (a) to (f)
4 790
4 930

80
Schedule 9, Part 2, item 5B
15 900
16 400

81
Schedule 9, Part 2, item 6, paragraph (a)
28 100
28 900

82
Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)
19 100
19 700

83
Schedule 9, Part 2, item 6, paragraph (d)
32 100
33 000

84
Schedule 9, Part 2, item 6AA
340
350

85
Schedule 9, Part 2, item 6AB
600
620

86
Schedule 9, Part 2, item 6ABA
1 820
1 870

87
Schedule 9, Part 2, item 6AC
1 020
1 050

88
Schedule 9, Part 2, item 6AD, paragraph (a)
19 100
19 700

89
Schedule 9, Part 2, item 6AD, paragraph (b)
4 790
4 930

90
Schedule 9, Part 2, item 6A
1 280
1 320

91
Schedule 9, Part 2, item 6B
3 210
3 300

92
Schedule 9, Part 2, item 6C
6 980
7 180

93
Schedule 9, Part 2, item 6D, paragraph (a)
9 170
9 440

94
Schedule 9, Part 2, item 6D, paragraph (b)
11 800
12 100

95
Schedule 9, Part 2, item 6D, paragraph (c)
16 100
16 600

96
Schedule 9, Part 2, item 6D, paragraph (d)
21 400
22 000

97
Schedule 9, Part 2, item 6D, paragraph (e)
32 100
33 000

98
Schedule 9, Part 2, item 6D, paragraph (f)
42 800
44 000

99
Schedule 9, Part 2, item 6D, paragraph (g)
64 100
66 000

100
Schedule 9, Part 2, item 7, paragraph (a)
9 580
9 860

101
Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)
7 970
8 200

102
Schedule 9, Part 2, item 7, paragraph (d)
32 100
33 000

103
Schedule 9, Part 2, item 7, paragraphs (e) and (f)
7 970
8 200

104
Schedule 9, Part 2, item 7A, paragraph (a)
9 170
9 440

105
Schedule 9, Part 2, item 7A, subparagraph (b)(i)
9 170
9 440

106
Schedule 9, Part 2, item 7A, subparagraph (b)(ii)
11 800
12 100

107
Schedule 9, Part 2, item 7A, subparagraph (b)(iii)
16 100
16 600

108
Schedule 9, Part 2, item 7A, subparagraph (b)(iv)
21 400
22 000

109
Schedule 9, Part 2, item 7A, subparagraph (b)(v)
32 100
33 000

110
Schedule 9, Part 2, item 7A, subparagraph (b)(vi)
42 800
44 000

111
Schedule 9, Part 2, item 7A, subparagraph (b)(vii)
64 100
66 000

112
Schedule 9, Part 2, item 7B, paragraph (a)
9 170
9 440

113
Schedule 9, Part 2, item 7B, subparagraph (b)(i)
9 170
9 440

114
Schedule 9, Part 2, item 7B, subparagraph (b)(ii)
11 800
12 100

115
Schedule 9, Part 2, item 7B, subparagraph (b)(iii)
16 100
16 600

116
Schedule 9, Part 2, item 7B, subparagraph (b)(iv)
21 400
22 000

117
Schedule 9, Part 2, item 7B, subparagraph (b)(v)
32 100
33 000

118
Schedule 9, Part 2, item 7B, subparagraph (b)(vi)
42 800
44 000

119
Schedule 9, Part 2, item 7B, subparagraph (b)(vii)
64 100
66 000

120
Schedule 9, Part 2, item 8
890
920

121
Schedule 9, Part 2, item 9, paragraph (a)
580
600

122
Schedule 9, Part 2, item 9, paragraph (b)
1 190
1 220

123
Schedule 9, Part 2, item 9AA
580
600

124
Schedule 9, Part 2, item 9AB
790
810

125
Schedule 9, Part 2, items 9AC and 9ACA
580
600

126
Schedule 9, Part 2, item 9AD, paragraph (a)
1 150
1 180

127
Schedule 9, Part 2, item 9AD, paragraph (b)
9 920
10 200

128
Schedule 9, Part 2, item 9AD, paragraph (c)
22 100
22 700

129
Schedule 9, Part 2, item 9AD, paragraph (d)
29 600
30 500

130
Schedule 9, Part 2, item 9AD, paragraph (e)
46 300
47 600

131
Schedule 9, Part 2, item 9AD, paragraph (f)
61 500
63 300

132
Schedule 9, Part 2, item 9AD, paragraph (g)
74 900
77 100

133
Schedule 9, Part 2, items 9B and 9C
15 900
16 400

134
Schedule 9, Part 2, item 10
140
150

135
Schedule 9, Part 2, items 14 and 14A
310
320

136
Schedule 9, Part 2, item 17, subparagraph (a)(i)
210
220

137
Schedule 9, Part 2, item 17, subparagraph (a)(ii)
260
270

138
Schedule 9, Part 2, item 17, subparagraph (a)(iii)
410
420

139
Schedule 9, Part 2, item 17, subparagraph (a)(iv)
100
110

140
Schedule 9, Part 2, item 17, paragraph (b)
$180
190

141
Schedule 9, Part 2, item 17, paragraph (c)
100
110

142
Schedule 9, Part 2, item 17A, subparagraph (a)(i)
1 050
1 080

143
Schedule 9, Part 2, item 17A, subparagraph (a)(ii)
550
570

144
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(A)
790
810

145
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(B)
220
230

146
Schedule 9, Part 2, item 17A, subparagraph (a)(iv)
380
390

147
Schedule 9, Part 2, item 17A, subparagraph (a)(v)
270
280

148
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(A)
210
220

149
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(B)
260
270

150
Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(C)
410
420

151
Schedule 9, Part 2, item 17A, paragraph (b)
$180
190

152
Schedule 9, Part 2, item 18
1 930
1 990

153
Schedule 9A, Part 2, items 1, 2 and 3
$950
$980

154
Schedule 9A, Part 2, item 4
$63 400
$65 200

155
Schedule 9A, Part 2, item 5
$126 700
$130 400

156
Schedule 9A, Part 2, item 6
$205 900
$211 900

157
Schedule 9A, Part 2, item 7
$20 500
$21 100

158
Schedule 9A, Part 2, item 8
$950
$980

159
Schedule 9A, Part 2, item 9
$5 810
$5 980

160
Schedule 9A, Part 2, item 10
$15 300
$15 700

161
Schedule 9A, Part 2, item 11
$30 100
$31 000

162
Schedule 9A, Part 2, item 12
$18 900
$19 400

163
Schedule 9A, Part 2, item 13
$14 300
$14 700

164
Schedule 9A, Part 2, item 14
$580
$600

165
Schedule 9A, Part 2, item 16
$22 800
$23 500

166
Schedule 9A, Part 2, item 17
$300
$310