Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013 (Cth)

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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

1Name of regulation

This regulation is the Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013.

2Commencement

This regulation commences on 1 July 2013.

3Authority

This regulation is made under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

4Schedule(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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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
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