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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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
