Commonwealth Numbered Regulations Commonwealth Numbered Regulations
Therapeutic Goods (Medical Devices) Regulations 2002
1 Amendments of listed provisions
|
Amendments of fees |
|||
|
Item |
Provision |
Omit |
Substitute |
|
1 |
Paragraph 9.4(2)(b) |
3 705 |
3 785 |
|
2 |
Schedule 5, item 1.1 |
920 |
940 |
|
3 |
Schedule 5, item 1.2, paragraph (a) |
7 965 |
8 135 |
|
4 |
Schedule 5, item 1.2, paragraph (b) |
8 020 |
8 190 |
|
5 |
Schedule 5, item 1.3, paragraph (a) |
48 800 |
49 800 |
|
6 |
Schedule 5, item 1.3, paragraph (b) |
37 600 |
38 400 |
|
7 |
Schedule 5, item 1.3A, paragraph (a) |
27 500 |
28 100 |
|
8 |
Schedule 5, item 1.3A, paragraph (b) |
58 700 |
59 900 |
|
9 |
Schedule 5, item 1.3A, paragraph (c) |
14 300 |
14 600 |
|
10 |
Schedule 5, item 1.3A, paragraph (d) |
3 460 |
3 535 |
|
11 |
Schedule 5, item 1.3A, paragraph (e) |
37 900 |
38 700 |
|
12 |
Schedule 5, item 1.3A, paragraph (f) |
24 200 |
24 700 |
|
13 |
Schedule 5, item 1.5, paragraphs (a) and (b) |
1 210 |
1 235 |
|
14 |
Schedule 5, item 1.5, paragraphs (c) to (f) |
940 |
960 |
|
15 |
Schedule 5, item 1.7 |
16 800 |
17 200 |
|
16 |
Schedule 5, item 1.8 |
330 |
335 |
|
17 |
Schedule 5, item 1.9, paragraph (a) |
27 400 |
28 000 |
|
18 |
Schedule 5, item 1.9, paragraph (b) |
54 000 |
55 100 |
|
19 |
Schedule 5, item 1.9, paragraph (c) |
37 600 |
38 400 |
|
20 |
Schedule 5, item 1.9, paragraph (d) |
26 200 |
26 800 |
|
21 |
Schedule 5, item 1.9, paragraph (e) |
24 000 |
24 500 |
|
22 |
Schedule 5, item 1.9, paragraph (f) |
20 500 |
20 900 |
|
23 |
Schedule 5, item 1.9A, paragraph (a) |
27 500 |
28 100 |
|
24 |
Schedule 5, item 1.9A, paragraph (b) |
58 700 |
59 900 |
|
25 |
Schedule 5, item 1.9A, paragraph (c) |
14 300 |
14 600 |
|
26 |
Schedule 5, item 1.9A, paragraph (d) |
3 460 |
3 535 |
|
27 |
Schedule 5, item 1.9A, paragraph (e) |
37 900 |
38 700 |
|
28 |
Schedule 5, item 1.9A, paragraph (f) |
24 200 |
24 700 |
|
29 |
Schedule 5, item 1.10, paragraph (a) |
16 500 |
16 800 |
|
30 |
Schedule 5, item 1.10, paragraph (b) |
32 500 |
33 200 |
|
31 |
Schedule 5, item 1.10, paragraph (c) |
22 600 |
23 100 |
|
32 |
Schedule 5, item 1.10, paragraph (d) |
14 300 |
14 600 |
|
33 |
Schedule 5, item 1.10, paragraph (e) |
12 400 |
12 700 |
|
34 |
Schedule 5, item 1.12 |
380 |
390 |
|
35 |
Schedule 5, item 1.13 |
3 545 |
3 620 |
|
36 |
Schedule 5, item 1.14 |
6 500 |
6 640 |
|
37 |
Schedule 5, item 1.14A |
6 330 |
6 465 |
|
38 |
Schedule 5, item 1.15 |
410 |
420 |
|
39 |
Schedule 5, item 1.17 |
940 |
960 |
|
40 |
Schedule 5, paragraph 2.1(b) |
380 |
390 |
Therapeutic Goods Regulations 1990
2 At the end of subregulation 3(3)
Add:
; (g) Medicines, Poisons and Therapeutic Goods Act (NT);
(h) Medicines, Poisons and Therapeutic Goods Regulations (NT).
3 Part 2 of Schedule 9 (after paragraph (bj) of table item 2)
Insert:
|
|
(bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4 |
1 035 |
4 Part 2 of Schedule 9 (paragraph (b) of the cell at table item 4, column 2)
After "paragraph (bb)", insert "or (bc)".
5 Part 2 of Schedule 9 (after paragraph (bb) of table item 4)
Insert:
|
|
(bc) an extension of indications that is the subject of an application to which regulation 16G applies |
4 120 |
6 Amendments of listed provisions
|
Amendments of fees etc. |
|||
|
Item |
Provision |
Omit |
Substitute |
|
1 |
Paragraph 43AAJ(1)(b) |
90 500 |
92 400 |
|
2 |
Paragraph 45(4A)(a) |
10 095 |
10 300 |
|
3 |
Paragraph 45(4A)(b) |
8 395 |
8 575 |
|
4 |
Paragraphs 45(4A)(c) and (ca) |
8 120 |
8 290 |
|
5 |
Paragraph 45(4A)(d) |
33 800 |
34 500 |
|
6 |
Paragraphs 45(4A)(e) and (f) |
8 120 |
8 290 |
|
7 |
Paragraphs 45(9)(a) to (e) |
5 050 |
5 155 |
|
8 |
Paragraphs 45(11)(a) to (e) |
1 845 |
1 885 |
|
9 |
Schedule 9, Part 2, item 1A |
430 |
440 |
|
10 |
Schedule 9, Part 2, item 1, paragraph (a) |
1 595 |
1 630 |
|
11 |
Schedule 9, Part 2, item 1, paragraph (b) |
19 900 |
20 300 |
|
12 |
Schedule 9, Part 2, item 1, paragraph (c) |
16 800 |
17 200 |
|
13 |
Schedule 9, Part 2, item 1, paragraph (d) |
2 530 |
2 585 |
|
14 |
Schedule 9, Part 2, item 2, paragraph (a) |
1 445 |
1 475 |
|
15 |
Schedule 9, Part 2, item 2, paragraph (b) |
1 350 |
1 380 |
|
16 |
Schedule 9, Part 2, item 2, paragraph (ba) |
44 200 |
45 100 |
|
17 |
Schedule 9, Part 2, item 2, paragraph (bb) |
14 700 |
15 000 |
|
18 |
Schedule 9, Part 2, item 2, paragraph (bc) |
29 500 |
30 100 |
|
19 |
Schedule 9, Part 2, item 2, paragraph (bd) |
26 300 |
26 900 |
|
20 |
Schedule 9, Part 2, item 2, subparagraph (be)(i) |
8 775 |
8 960 |
|
21 |
Schedule 9, Part 2, item 2, subparagraph (be)(ii) |
5 725 |
5 845 |
|
22 |
Schedule 9, Part 2, item 2, subparagraph (bf)(i) |
17 600 |
18 000 |
|
23 |
Schedule 9, Part 2, item 2, subparagraph (bf)(ii) |
11 500 |
11 700 |
|
24 |
Schedule 9, Part 2, item 2, paragraph (bg) |
17 000 |
17 400 |
|
25 |
Schedule 9, Part 2, item 2, paragraph (bh) |
2 785 |
2 845 |
|
26 |
Schedule 9, Part 2, item 2, paragraph (bi) |
17 200 |
17 600 |
|
27 |
Schedule 9, Part 2, item 2, paragraph (bj) |
1 015 |
1 035 |
|
28 |
Schedule 9, Part 2, item 2, paragraph (c) |
4 025 |
4 110 |
|
29 |
Schedule 9, Part 2, item 2, paragraph (d) |
2 015 |
2 060 |
|
30 |
Schedule 9, Part 2, item 2, paragraph (d) |
11 700 |
11 900 |
|
31 |
Schedule 9, Part 2, item 2, paragraph (f) |
635 |
650 |
|
32 |
Schedule 9, Part 2, item 2, paragraph (g) |
1 350 |
1 380 |
|
33 |
Schedule 9, Part 2, item 2, paragraph (h) |
675 |
690 |
|
34 |
Schedule 9, Part 2, item 2AA |
615 |
630 |
|
35 |
Schedule 9, Part 2, item 2A, paragraph (a) |
1 555 |
1 590 |
|
36 |
Schedule 9, Part 2, item 2A, paragraph (b) |
1 445 |
1 475 |
|
37 |
Schedule 9, Part 2, item 2A, paragraph (c) |
380 |
390 |
|
38 |
Schedule 9, Part 2, item 2A, paragraphs (d) to (g) |
410 |
420 |
|
39 |
Schedule 9, Part 2, item 2AB |
390 |
400 |
|
40 |
Schedule 9, Part 2, item 2AC |
1 015 |
1 035 |
|
41 |
Schedule 9, Part 2, item 2B |
5 050 |
5 155 |
|
42 |
Schedule 9, Part 2, item 2C |
4 035 |
4 120 |
|
43 |
Schedule 9, Part 2, item 2CA |
5 050 |
5 155 |
|
44 |
Schedule 9, Part 2, item 3, paragraph (a) |
410 |
420 |
|
45 |
Schedule 9, Part 2, item 3, paragraph (b) |
760 |
775 |
|
46 |
Schedule 9, Part 2, item 3AA |
615 |
630 |
|
47 |
Schedule 9, Part 2, item 4, paragraph (a) |
177 200 |
181 000 |
|
48 |
Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii) |
59 100 |
60 400 |
|
49 |
Schedule 9, Part 2, item 4, subparagraph (aa)(iii) |
118 000 |
120 500 |
|
50 |
Schedule 9, Part 2, item 4, paragraph (b) |
105 300 |
107 500 |
|
51 |
Schedule 9, Part 2, item 4, subparagraph (bb)(i) |
35 100 |
35 800 |
|
52 |
Schedule 9, Part 2, item 4, subparagraph (bb)(i) |
22 700 |
23 200 |
|
53 |
Schedule 9, Part 2, item 4, subparagraph (bb)(ii) |
35 100 |
35 800 |
|
54 |
Schedule 9, Part 2, item 4, subparagraph (bb)(ii) |
22 700 |
23 200 |
|
55 |
Schedule 9, Part 2, item 4, subparagraph (bb)(iii) |
70 100 |
71 600 |
|
56 |
Schedule 9, Part 2, item 4, subparagraph (bb)(iii) |
45 800 |
46 800 |
|
57 |
Schedule 9, Part 2, item 4, paragraph (c) |
67 600 |
69 000 |
|
58 |
Schedule 9, Part 2, item 4, paragraph (d) |
11 200 |
11 400 |
|
59 |
Schedule 9, Part 2, item 4, paragraph (g) |
68 500 |
70 000 |
|
60 |
Schedule 9, Part 2, item 4, paragraph (h) |
4 035 |
4 120 |
|
61 |
Schedule 9, Part 2, item 5, paragraph (a) |
9 665 |
9 870 |
|
62 |
Schedule 9, Part 2, item 5, subparagraph (b)(i) |
9 665 |
9 870 |
|
63 |
Schedule 9, Part 2, item 5, subparagraph (b)(ii) |
12 400 |
12 700 |
|
64 |
Schedule 9, Part 2, item 5, subparagraph (b)(iii) |
17 000 |
17 400 |
|
65 |
Schedule 9, Part 2, item 5, subparagraph (b)(iv) |
22 500 |
23 000 |
|
66 |
Schedule 9, Part 2, item 5, subparagraph (b)(v) |
33 800 |
34 500 |
|
67 |
Schedule 9, Part 2, item 5, subparagraph (b)(vi) |
45 100 |
46 100 |
|
68 |
Schedule 9, Part 2, item 5, subparagraph (b)(vii) |
67 600 |
69 000 |
|
69 |
Schedule 9, Part 2, item 5, paragraph (c) |
3 490 |
3 565 |
|
70 |
Schedule 9, Part 2, item 5, subparagraph (d)(i) |
3 490 |
3 565 |
|
71 |
Schedule 9, Part 2, item 5, subparagraph (d)(ii) |
12 400 |
12 700 |
|
72 |
Schedule 9, Part 2, item 5, subparagraph (d)(iii) |
17 000 |
17 400 |
|
73 |
Schedule 9, Part 2, item 5, subparagraph (d)(iv) |
22 500 |
23 000 |
|
74 |
Schedule 9, Part 2, item 5, subparagraph (d)(v) |
33 800 |
34 500 |
|
75 |
Schedule 9, Part 2, item 5, subparagraph (d)(vi) |
45 100 |
46 100 |
|
76 |
Schedule 9, Part 2, item 5, subparagraph (d)(vii) |
67 600 |
69 000 |
|
77 |
Schedule 9, Part 2, item 5A, paragraphs (a) to (f) |
5 050 |
5 155 |
|
78 |
Schedule 9, Part 2, item 5B |
16 800 |
17 200 |
|
79 |
Schedule 9, Part 2, item 6, paragraph (a) |
29 600 |
30 200 |
|
80 |
Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca) |
20 200 |
20 600 |
|
81 |
Schedule 9, Part 2, item 6, paragraph (d) |
33 800 |
34 500 |
|
82 |
Schedule 9, Part 2, item 6AA |
360 |
370 |
|
83 |
Schedule 9, Part 2, item 6AB |
635 |
650 |
|
84 |
Schedule 9, Part 2, item 6ABA |
1 915 |
1 955 |
|
85 |
Schedule 9, Part 2, item 6AC |
1 075 |
1 100 |
|
86 |
Schedule 9, Part 2, item 6AD, paragraph (a) |
20 200 |
20 600 |
|
87 |
Schedule 9, Part 2, item 6AD, paragraph (b) |
5 050 |
5 155 |
|
88 |
Schedule 9, Part 2, item 6A |
1 350 |
1 380 |
|
89 |
Schedule 9, Part 2, item 6B |
3 380 |
3 450 |
|
90 |
Schedule 9, Part 2, item 6C |
7 350 |
7 505 |
|
91 |
Schedule 9, Part 2, item 6D, paragraph (a) |
9 665 |
9 870 |
|
92 |
Schedule 9, Part 2, item 6D, paragraph (b) |
12 400 |
12 700 |
|
93 |
Schedule 9, Part 2, item 6D, paragraph (c) |
17 000 |
17 400 |
|
94 |
Schedule 9, Part 2, item 6D, paragraph (d) |
22 500 |
23 000 |
|
95 |
Schedule 9, Part 2, item 6D, paragraph (e) |
33 800 |
34 500 |
|
96 |
Schedule 9, Part 2, item 6D, paragraph (f) |
45 100 |
46 100 |
|
97 |
Schedule 9, Part 2, item 6D, paragraph (g) |
67 600 |
69 000 |
|
98 |
Schedule 9, Part 2, item 7, paragraph (a) |
10 095 |
10 300 |
|
99 |
Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca) |
8 395 |
8 575 |
|
100 |
Schedule 9, Part 2, item 7, paragraph (d) |
33 800 |
34 500 |
|
101 |
Schedule 9, Part 2, item 7, paragraphs (e) and (f) |
8 395 |
8 575 |
|
102 |
Schedule 9, Part 2, item 7A, paragraph (a) |
9 665 |
9 870 |
|
103 |
Schedule 9, Part 2, item 7A, subparagraph (b)(i) |
9 665 |
9 870 |
|
104 |
Schedule 9, Part 2, item 7A, subparagraph (b)(ii) |
12 400 |
12 700 |
|
105 |
Schedule 9, Part 2, item 7A, subparagraph (b)(iii) |
17 000 |
17 400 |
|
106 |
Schedule 9, Part 2, item 7A, subparagraph (b)(iv) |
22 500 |
23 000 |
|
107 |
Schedule 9, Part 2, item 7A, subparagraph (b)(v) |
33 800 |
34 500 |
|
108 |
Schedule 9, Part 2, item 7A, subparagraph (b)(vi) |
45 100 |
46 100 |
|
109 |
Schedule 9, Part 2, item 7A, subparagraph (b)(vii) |
67 600 |
69 000 |
|
110 |
Schedule 9, Part 2, item 7B, paragraph (a) |
9 665 |
9 870 |
|
111 |
Schedule 9, Part 2, item 7B, subparagraph (b)(i) |
9 665 |
9 870 |
|
112 |
Schedule 9, Part 2, item 7B, subparagraph (b)(ii) |
12 400 |
12 700 |
|
113 |
Schedule 9, Part 2, item 7B, subparagraph (b)(iii) |
17 000 |
17 400 |
|
114 |
Schedule 9, Part 2, item 7B, subparagraph (b)(iv) |
22 500 |
23 000 |
|
115 |
Schedule 9, Part 2, item 7B, subparagraph (b)(v) |
33 800 |
34 500 |
|
116 |
Schedule 9, Part 2, item 7B, subparagraph (b)(vi) |
45 100 |
46 100 |
|
117 |
Schedule 9, Part 2, item 7B, subparagraph (b)(vii) |
67 600 |
69 000 |
|
118 |
Schedule 9, Part 2, item 8 |
940 |
960 |
|
119 |
Schedule 9, Part 2, item 9, paragraph (a) |
615 |
630 |
|
120 |
Schedule 9, Part 2, item 9, paragraph (b) |
1 250 |
1 275 |
|
121 |
Schedule 9, Part 2, item 9AA |
615 |
630 |
|
122 |
Schedule 9, Part 2, item 9AB |
830 |
850 |
|
123 |
Schedule 9, Part 2, items 9AC and 9ACA |
615 |
630 |
|
124 |
Schedule 9, Part 2, item 9AD, paragraph (a) |
1 210 |
1 235 |
|
125 |
Schedule 9, Part 2, item 9AD, paragraph (b) |
10 400 |
10 600 |
|
126 |
Schedule 9, Part 2, item 9AD, paragraph (c) |
23 200 |
23 700 |
|
127 |
Schedule 9, Part 2, item 9AD, paragraph (d) |
31 200 |
31 900 |
|
128 |
Schedule 9, Part 2, item 9AD, paragraph (e) |
48 700 |
49 700 |
|
129 |
Schedule 9, Part 2, item 9AD, paragraph (f) |
64 800 |
66 200 |
|
130 |
Schedule 9, Part 2, item 9AD, paragraph (g) |
79 000 |
80 700 |
|
131 |
Schedule 9, Part 2, items 9B and 9C |
16 800 |
17 200 |
|
132 |
Schedule 9, Part 2, item 10 |
155 |
160 |
|
133 |
Schedule 9, Part 2, items 14 and 14A |
330 |
335 |
|
134 |
Schedule 9, Part 2, item 17, subparagraph (a)(i) |
225 |
230 |
|
135 |
Schedule 9, Part 2, item 17, subparagraph (a)(ii) |
275 |
280 |
|
136 |
Schedule 9, Part 2, item 17, subparagraph (a)(iii) |
430 |
440 |
|
137 |
Schedule 9, Part 2, item 17, paragraph (b) |
195 |
200 |
|
138 |
Schedule 9, Part 2, item 17A, subparagraph (a)(i) |
1 105 |
1 130 |
|
139 |
Schedule 9, Part 2, item 17A, subparagraph (a)(ii) |
585 |
595 |
|
140 |
Schedule 9, Part 2, item 17A, sub-subparagraph (a)(iii)(A) |
830 |
850 |
|
141 |
Schedule 9, Part 2, item 17A, sub-subparagraph (a)(iii)(B) |
235 |
240 |
|
142 |
Schedule 9, Part 2, item 17A, subparagraph (a)(iv) |
400 |
410 |
|
143 |
Schedule 9, Part 2, item 17A, subparagraph (a)(v) |
285 |
290 |
|
144 |
Schedule 9, Part 2, item 17A, sub-subparagraph (a)(vi)(A) |
225 |
230 |
|
145 |
Schedule 9, Part 2, item 17A, sub-subparagraph (a)(vi)(B) |
275 |
280 |
|
146 |
Schedule 9, Part 2, item 17A, sub-subparagraph (a)(vi)(C) |
430 |
440 |
|
147 |
Schedule 9, Part 2, item 17A, paragraph (b) |
195 |
200 |
|
148 |
Schedule 9, Part 2, item 18 |
2 040 |
2 085 |
|
149 |
Schedule 9A, Part 2, items 1, 2 and 3 |
1 005 |
1 025 |
|
150 |
Schedule 9A, Part 2, item 4 |
66 800 |
68 200 |
|
151 |
Schedule 9A, Part 2, item 5 |
133 500 |
136 300 |
|
152 |
Schedule 9A, Part 2, item 6 |
217 000 |
221 600 |
|
153 |
Schedule 9A, Part 2, item 7 |
21 600 |
22 100 |
|
154 |
Schedule 9A, Part 2, item 8 |
1 005 |
1 025 |
|
155 |
Schedule 9A, Part 2, item 9 |
6 125 |
6 255 |
|
156 |
Schedule 9A, Part 2, item 10 |
16 100 |
16 400 |
|
157 |
Schedule 9A, Part 2, item 11 |
31 700 |
32 400 |
|
158 |
Schedule 9A, Part 2, item 12 |
19 900 |
20 300 |
|
159 |
Schedule 9A, Part 2, item 13 |
15 100 |
15 400 |
|
160 |
Schedule 9A, Part 2, item 14 |
615 |
630 |
|
161 |
Schedule 9A, Part 2, item 16 |
24 100 |
24 600 |
|
162 |
Schedule 9A, Part 2, item 17 |
315 |
320 |