Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020
I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.
David Hurley
Governor‑General
By His Excellency’s Command
Greg Hunt
Minister for Health
Contents
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
Part 1—Fees
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Regulations 1990
Part 2—Other measures
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Regulations 1990
This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2020.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | 1 July 2020. | 1 July 2020 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under the Therapeutic Goods Act 1989.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Therapeutic Goods (Medical Devices) Regulations 2002
1 Amendments of listed provisions
Item | Provision | Substitute | |
1 | Schedule 5, Part 1, item 1.1 | 1,020 | 1,040 |
2 | Schedule 5, Part 1, item 1.1A | 10,000 | 10,200 |
3 | Schedule 5, Part 1, item 1.2, paragraph (a) | 8,800 | 8,970 |
4 | Schedule 5, Part 1, item 1.2, paragraph (b) | 8,850 | 9,020 |
5 | Schedule 5, Part 1, item 1.3, paragraph (a) | 53,800 | 54,800 |
6 | Schedule 5, Part 1, item 1.3, paragraph (b) | 41,500 | 42,300 |
7 | Schedule 5, Part 1, item 1.3A, paragraph (a) | 30,400 | 31,000 |
8 | Schedule 5, Part 1, item 1.3A, paragraph (b) | 64,700 | 66,000 |
9 | Schedule 5, Part 1, item 1.3A, paragraph (c) | 15,700 | 16,000 |
10 | Schedule 5, Part 1, item 1.3A, paragraph (d) | 3,820 | 3,890 |
11 | Schedule 5, Part 1, item 1.3A, paragraph (e) | 41,900 | 42,700 |
12 | Schedule 5, Part 1, item 1.3A, paragraph (f) | 26,700 | 27,200 |
13 | Schedule 5, Part 1, item 1.4A | 4,570 | 4,660 |
14 | Schedule 5, Part 1, items 1.4B and 1.4C | 2,510 | 2,560 |
15 | Schedule 5, Part 1, item 1.4D | 74,600 | 76,100 |
16 | Schedule 5, Part 1, items 1.4E and 1.4F | 53,600 | 54,600 |
17 | Schedule 5, Part 1, item 1.5, paragraphs (a) and (b) | 1,340 | 1,370 |
18 | Schedule 5, Part 1, item 1.5, paragraphs (c), (d) and (e) | 1,040 | 1,060 |
19 | Schedule 5, Part 1, item 1.5, paragraph (g) | 540 | 550 |
20 | Schedule 5, Part 1, item 1.5, paragraph (h) | 1,040 | 1,060 |
21 | Schedule 5, Part 1, item 1.5A | 10,000 | 10,200 |
22 | Schedule 5, Part 1, item 1.7 | 18,600 | 19,000 |
23 | Schedule 5, Part 1, item 1.8 | 370 | 380 |
24 | Schedule 5, Part 1, item 1.9, paragraph (a) | 30,300 | 30,900 |
25 | Schedule 5, Part 1, item 1.9, paragraph (b) | 59,500 | 60,700 |
26 | Schedule 5, Part 1, item 1.9, paragraph (c) | 41,500 | 42,300 |
27 | Schedule 5, Part 1, item 1.9, paragraph (d) | 29,000 | 29,600 |
28 | Schedule 5, Part 1, item 1.9, paragraph (e) | 26,500 | 27,000 |
29 | Schedule 5, Part 1, item 1.9, paragraph (f) | 22,700 | 23,100 |
30 | Schedule 5, Part 1, item 1.9A, paragraph (a) | 30,400 | 31,000 |
31 | Schedule 5, Part 1, item 1.9A, paragraph (b) | 64,700 | 66,000 |
32 | Schedule 5, Part 1, item 1.9A, paragraph (c) | 15,700 | 16,000 |
33 | Schedule 5, Part 1, item 1.9A, paragraph (d) | 3,820 | 3,890 |
34 | Schedule 5, Part 1, item 1.9A, paragraph (e) | 41,900 | 42,700 |
35 | Schedule 5, Part 1, item 1.9A, paragraph (f) | 26,700 | 27,200 |
36 | Schedule 5, Part 1, item 1.10, paragraph (a) | 18,200 | 18,600 |
37 | Schedule 5, Part 1, item 1.10, paragraph (b) | 35,900 | 36,600 |
38 | Schedule 5, Part 1, item 1.10, paragraph (c) | 25,000 | 25,500 |
39 | Schedule 5, Part 1, item 1.10, paragraph (d) | 15,700 | 16,000 |
40 | Schedule 5, Part 1, item 1.10, paragraph (e) | 13,800 | 14,100 |
41 | Schedule 5, Part 1, item 1.12 | 430 | 440 |
42 | Schedule 5, Part 1, item 1.13 | 3,910 | 3,990 |
43 | Schedule 5, Part 1, item 1.14 | 7,170 | 7,310 |
44 | Schedule 5, Part 1, item 1.14A | 6,990 | 7,130 |
45 | Schedule 5, Part 1, item 1.14B | 64,700 | 66,000 |
46 | Schedule 5, Part 1, item 1.14C | 15,700 | 16,000 |
47 | Schedule 5, Part 1, item 1.17 | 1,040 | 1,060 |
48 | Schedule 5, Part 2, paragraph 2.1(b) | 430 | 440 |
Therapeutic Goods Regulations 1990
2 Amendments of listed provisions
Amendments relating to fees | |||
Item | Provision | Substitute | |
1 | Paragraph 43AAJ(1)(b) | 99,900 | 101,800 |
2 | Paragraph 43AC(2)(a) | 4,080 | 4,160 |
3 | Paragraph 43AC(2)(b) | 6,850 | 6,980 |
4 | Paragraph 43AC(2)(c) | 8,930 | 9,100 |
5 | Paragraph 43ACA(2)(aa) | 1,070 | 1,090 |
6 | Paragraph 43ACA(2)(ab) | 7,770 | 7,920 |
7 | Paragraph 43ACA(2)(a) | 4,120 | 4,200 |
8 | Paragraph 43ACA(2)(b) | 6,440 | 6,570 |
9 | Paragraph 43ACA(2)(c) | 9,520 | 9,710 |
10 | Paragraph 45(6)(a) | 1,120 | 1,140 |
11 | Paragraph 45(6)(b) | 4,450 | 4,540 |
12 | Schedule 9, clause 3, item 1, paragraph (a) | 1,760 | 1,790 |
13 | Schedule 9, clause 3, item 1, paragraph (b) | 21,900 | 22,300 |
14 | Schedule 9, clause 3, item 1AA | 12,800 | 13,000 |
15 | Schedule 9, clause 3, item 1AB | 4,610 | 4,700 |
16 | Schedule 9, clause 3, item 1AC, paragraph (a) | 48,900 | 49,900 |
17 | Schedule 9, clause 3, item 1AC, paragraph (b) | 29,200 | 29,800 |
18 | Schedule 9, clause 3, item 1AD, paragraph (a) | 255,300 | 260,300 |
19 | Schedule 9, clause 3, item 1AD, paragraph (b) | 168,400 | 171,700 |
20 | Schedule 9, clause 3, item 1AE | 29,100 | 29,700 |
21 | Schedule 9, clause 3, item 1AF | 122,800 | 125,200 |
22 | Schedule 9, clause 3, item 1AG | 17,600 | 17,900 |
23 | Schedule 9, clause 3, item 1B | 12,800 | 13,000 |
24 | Schedule 9, clause 3, item 2, paragraph (ba) | 48,800 | 49,800 |
25 | Schedule 9, clause 3, item 2, paragraph (bb) | 16,200 | 16,500 |
26 | Schedule 9, clause 3, item 2, paragraph (bc) | 32,600 | 33,200 |
27 | Schedule 9, clause 3, item 2, paragraph (bca) | 51,700 | 52,700 |
28 | Schedule 9, clause 3, item 2, paragraph (bd) | 29,100 | 29,700 |
29 | Schedule 9, clause 3, item 2, subparagraph (be)(i) | 9,680 | 9,870 |
30 | Schedule 9, clause 3, item 2, subparagraph (be)(ii) | 6,320 | 6,440 |
31 | Schedule 9, clause 3, item 2, subparagraph (bf)(i) | 19,500 | 19,900 |
32 | Schedule 9, clause 3, item 2, subparagraph (bf)(ii) | 12,700 | 12,900 |
33 | Schedule 9, clause 3, item 2, paragraph (bfa) | 30,800 | 31,400 |
34 | Schedule 9, clause 3, item 2, paragraph (bg) | 18,800 | 19,200 |
35 | Schedule 9, clause 3, item 2, paragraph (bh) | 3,080 | 3,140 |
36 | Schedule 9, clause 3, item 2, paragraph (bi) | 19,000 | 19,400 |
37 | Schedule 9, clause 3, item 2, paragraphs (bj) and (bk) | 1,120 | 1,140 |
38 | Schedule 9, clause 3, item 2, paragraph (c) | 4,440 | 4,530 |
39 | Schedule 9, clause 3, item 2, paragraph (d) | 2,220 | 2,260 |
40 | Schedule 9, clause 3, item 2, paragraph (d) | 12,900 | 13,200 |
41 | Schedule 9, clause 3, item 2AB | 440 | 450 |
42 | Schedule 9, clause 3, item 2AC | 1,120 | 1,140 |
43 | Schedule 9, clause 3, item 2B | 5,570 | 5,680 |
44 | Schedule 9, clause 3, item 2C | 4,450 | 4,540 |
45 | Schedule 9, clause 3, item 2CA | 5,570 | 5,680 |
46 | Schedule 9, clause 3, items 2CB, 2CC and 2CD | 810 | 830 |
47 | Schedule 9, clause 3, item 2CE, paragraphs (a) and (b) | 810 | 830 |
48 | Schedule 9, clause 3, item 3, paragraph (a) | 460 | 470 |
49 | Schedule 9, clause 3, item 3, paragraph (b) | 840 | 860 |
50 | Schedule 9, clause 3, item 3AB, paragraphs (a) and (b) | 430 | 440 |
51 | Schedule 9, clause 3, item 4, paragraph (a) | 195,700 | 199,500 |
52 | Schedule 9, clause 3, item 4, subparagraphs (aa)(i) and (ii) | 65,300 | 66,600 |
53 | Schedule 9, clause 3, item 4, subparagraph (aa)(iii) | 130,200 | 132,700 |
54 | Schedule 9, clause 3, item 4, paragraph (ab) | 207,000 | 211,000 |
55 | Schedule 9, clause 3, item 4, paragraph (b) | 116,100 | 118,400 |
56 | Schedule 9, clause 3, item 4, subparagraph (bb)(i) | 38,700 | 39,500 |
57 | Schedule 9, clause 3, item 4, subparagraph (bb)(i) | 25,100 | 25,600 |
58 | Schedule 9, clause 3, item 4, subparagraph (bb)(ii) | 38,700 | 39,500 |
59 | Schedule 9, clause 3, item 4, subparagraph (bb)(ii) | 25,100 | 25,600 |
60 | Schedule 9, clause 3, item 4, subparagraph (bb)(iii) | 77,400 | 78,900 |
61 | Schedule 9, clause 3, item 4, subparagraph (bb)(iii) | 50,600 | 51,600 |
62 | Schedule 9, clause 3, item 4, paragraph (bc) | 4,450 | 4,540 |
63 | Schedule 9, clause 3, item 4, paragraph (bd) | 123,100 | 125,500 |
64 | Schedule 9, clause 3, item 4, paragraph (c) | 74,700 | 76,200 |
65 | Schedule 9, clause 3, item 4, paragraph (d) | 12,300 | 12,500 |
66 | Schedule 9, clause 3, item 4, paragraph (g) | 75,700 | 77,200 |
67 | Schedule 9, clause 3, item 4, paragraph (h) | 4,450 | 4,540 |
68 | Schedule 9, clause 3, item 6AA | 650 | 660 |
69 | Schedule 9, clause 3, item 6AB | 700 | 710 |
70 | Schedule 9, clause 3, item 6ABA | 2,480 | 2,530 |
71 | Schedule 9, clause 3, item 6AC | 1,180 | 1,200 |
72 | Schedule 9, clause 3, item 6B | 3,740 | 3,810 |
73 | Schedule 9, clause 3, item 6C | 8,110 | 8,270 |
74 | Schedule 9, clause 3, item 6D, paragraph (a) | 10,700 | 10,900 |
75 | Schedule 9, clause 3, item 6D, paragraph (b) | 13,800 | 14,100 |
76 | Schedule 9, clause 3, item 6D, paragraph (c) | 18,800 | 19,200 |
77 | Schedule 9, clause 3, item 6D, paragraph (d) | 24,900 | 25,400 |
78 | Schedule 9, clause 3, item 6D, paragraph (e) | 37,400 | 38,100 |
79 | Schedule 9, clause 3, item 6D, paragraph (f) | 49,800 | 50,800 |
80 | Schedule 9, clause 3, item 6D, paragraph (g) | 74,700 | 76,200 |
81 | Schedule 9, clause 3, item 7A, paragraph (a) | 10,700 | 10,900 |
82 | Schedule 9, clause 3, item 7A, subparagraph (b)(i) | 10,700 | 10,900 |
83 | Schedule 9, clause 3, item 7A, subparagraph (b)(ii) | 13,800 | 14,100 |
84 | Schedule 9, clause 3, item 7A, subparagraph (b)(iii) | 18,800 | 19,200 |
85 | Schedule 9, clause 3, item 7A, subparagraph (b)(iv) | 24,900 | 25,400 |
86 | Schedule 9, clause 3, item 7A, subparagraph (b)(v) | 37,400 | 38,100 |
87 | Schedule 9, clause 3, item 7A, subparagraph (b)(vi) | 49,800 | 50,800 |
88 | Schedule 9, clause 3, item 7A, subparagraph (b)(vii) | 74,700 | 76,200 |
89 | Schedule 9, clause 3, item 7B, paragraph (a) | 10,700 | 10,900 |
90 | Schedule 9, clause 3, item 7B, subparagraph (b)(i) | 10,700 | 10,900 |
91 | Schedule 9, clause 3, item 7B, subparagraph (b)(ii) | 13,800 | 14,100 |
92 | Schedule 9, clause 3, item 7B, subparagraph (b)(iii) | 18,800 | 19,200 |
93 | Schedule 9, clause 3, item 7B, subparagraph (b)(iv) | 24,900 | 25,400 |
94 | Schedule 9, clause 3, item 7B, subparagraph (b)(v) | 37,400 | 38,100 |
95 | Schedule 9, clause 3, item 7B, subparagraph (b)(vi) | 49,800 | 50,800 |
96 | Schedule 9, clause 3, item 7B, subparagraph (b)(vii) | 74,700 | 76,200 |
97 | Schedule 9, clause 3, item 7C | 1,060 | 1,080 |
98 | Schedule 9, clause 3, item 8, paragraph (a) | 790 | 810 |
99 | Schedule 9, clause 3, item 8, paragraph (b) | 1,040 | 1,060 |
100 | Schedule 9, clause 3, items 8A, 8B and 8C | 790 | 810 |
101 | Schedule 9, clause 3, item 9, paragraph (a) | 990 | 1,010 |
102 | Schedule 9, clause 3, item 9, paragraph (b) | 1,390 | 1,420 |
103 | Schedule 9, clause 3, item 9AA | 680 | 690 |
104 | Schedule 9, clause 3, item 9AB | 920 | 940 |
105 | Schedule 9, clause 3, items 9AC and 9ACA | 680 | 690 |
106 | Schedule 9, clause 3, item 9AD, paragraph (a) | 1,340 | 1,370 |
107 | Schedule 9, clause 3, item 9AD, paragraph (b) | 11,400 | 11,600 |
108 | Schedule 9, clause 3, item 9AD, paragraph (c) | 25,600 | 26,100 |
109 | Schedule 9, clause 3, item 9AD, paragraph (d) | 34,400 | 35,100 |
110 | Schedule 9, clause 3, item 9AD, paragraph (e) | 53,700 | 54,700 |
111 | Schedule 9, clause 3, item 9AD, paragraph (f) | 71,500 | 72,900 |
112 | Schedule 9, clause 3, item 9AD, paragraph (g) | 87,300 | 89,000 |
113 | Schedule 9, clause 3, item 14, paragraphs (a) and (b) | 370 | 380 |
114 | Schedule 9, clause 3, item 17, subparagraph (a)(i) | 260 | 270 |
115 | Schedule 9, clause 3, item 17, subparagraph (a)(ii) | 310 | 320 |
116 | Schedule 9, clause 3, item 17, subparagraph (a)(iii) | 480 | 490 |
117 | Schedule 9, clause 3, item 17A, subparagraph (a)(i) | 1,210 | 1,230 |
118 | Schedule 9, clause 3, item 17A, subparagraph (a)(ii) | 640 | 650 |
119 | Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(iii)(A) | 920 | 940 |
120 | Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(iii)(B) | 260 | 270 |
121 | Schedule 9, clause 3, item 17A, subparagraph (a)(iv) | 450 | 460 |
122 | Schedule 9, clause 3, item 17A, subparagraph (a)(v) | 320 | 330 |
123 | Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(A) | 260 | 270 |
124 | Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(B) | 310 | 320 |
125 | Schedule 9, clause 3, item 17A, sub‑subparagraph (a)(vi)(C) | 480 | 490 |
126 | Schedule 9, clause 3, item 18 | 2,260 | 2,300 |
127 | Schedule 9, clause 4, item 1, paragraphs (a) and (b) | 1,650 | 1,680 |
128 | Schedule 9, clause 4, item 1, paragraph (c) | 2,650 | 2,700 |
129 | Schedule 9, clause 4, item 1, paragraph (d) | 3,870 | 3,950 |
130 | Schedule 9, clause 4, item 1, paragraph (e) | 5,740 | 5,850 |
131 | Schedule 9, clause 4, item 1, paragraphs (f), (g) and (h) | 1,650 | 1,680 |
132 | Schedule 9, clause 4, item 1, paragraph (i) | 2,650 | 2,700 |
133 | Schedule 9, clause 4, item 2, paragraph (a) | 4,080 | 4,160 |
134 | Schedule 9, clause 4, item 2, paragraph (b) | 5,800 | 5,910 |
135 | Schedule 9, clause 4, item 2, paragraph (c) | 8,930 | 9,100 |
136 | Schedule 9, clause 4, item 2, paragraph (d) | 14,800 | 15,100 |
137 | Schedule 9, clause 4, item 2, paragraph (e) | 21,900 | 22,300 |
138 | Schedule 9, clause 4, item 2, paragraph (f) | 4,080 | 4,160 |
139 | Schedule 9, clause 4, item 2, paragraph (g) | 6,850 | 6,980 |
140 | Schedule 9, clause 4, item 2, paragraph (h) | 8,930 | 9,100 |
141 | Schedule 9, clause 4, item 3, paragraphs (d) and (e) | 830 | 850 |
142 | Schedule 9, clause 4, item 3, paragraphs (f), (g) and (h) | 1,330 | 1,360 |
143 | Schedule 9, clause 4, item 4, paragraphs (d), (e) and (f) | 4520 | 4,610 |
144 | Schedule 9, clause 4, item 5, paragraph (a) | 1,650 | 1,680 |
145 | Schedule 9, clause 4, item 5, paragraph (b) | 5,740 | 5,850 |
146 | Schedule 9, clause 4, item 5, paragraph (c) | 8,500 | 8,670 |
147 | Schedule 9, clause 4, item 5, paragraph (d) | 11,600 | 11,800 |
148 | Schedule 9, clause 4, item 7, paragraph (a) | 1,620 | 1,650 |
149 | Schedule 9, clause 4, item 7, paragraph (b) | 8,310 | 8,470 |
150 | Schedule 9, clause 5, item 1A | 1,990 | 2,030 |
151 | Schedule 9, clause 5, item 1B | 8,690 | 8,860 |
152 | Schedule 9, clause 5, item 1C | 790 | 810 |
153 | Schedule 9, clause 5, items 1D and 1E | 920 | 940 |
154 | Schedule 9, clause 5, item 1F | 790 | 810 |
155 | Schedule 9, clause 5, item 1G | 1,070 | 1,090 |
156 | Schedule 9, clause 5, item 1H | 7,770 | 7,920 |
157 | Schedule 9, clause 5, item 1 | 1,440 | 1,470 |
158 | Schedule 9, clause 5, item 2 | 4,880 | 4,980 |
159 | Schedule 9, clause 5, item 3 | 7,250 | 7,390 |
160 | Schedule 9, clause 5, item 4 | 10,300 | 10,500 |
161 | Schedule 9, clause 5, item 5 | 1,440 | 1,470 |
162 | Schedule 9, clause 5, item 6 | 760 | 770 |
163 | Schedule 9, clause 5, item 7 | 4,120 | 4,200 |
164 | Schedule 9, clause 5, item 8 | 810 | 830 |
165 | Schedule 9, clause 5, item 9 | 6,440 | 6,570 |
166 | Schedule 9, clause 5, item 10 | 830 | 850 |
167 | Schedule 9, clause 5, item 11 | 9,520 | 9,710 |
168 | Schedule 9, clause 5, item 12 | 550 | 560 |
169 | Schedule 9, clause 5, item 13 | 3,180 | 3,240 |
170 | Schedule 9, clause 5, item 14 | 1,990 | 2,030 |
171 | Schedule 9, clause 5, item 15 | 21,300 | 21,700 |
172 | Schedule 9, clause 5, item 16 | 1,990 | 2,030 |
173 | Schedule 9, clause 5, item 17 | 21,300 | 21,700 |
174 | Schedule 9, clause 5, item 18 | 2,630 | 2,680 |
175 | Schedule 9, clause 5, item 19 | 28,900 | 29,500 |
176 | Schedule 9, clause 5, item 20 | 2,880 | 2,940 |
177 | Schedule 9, clause 5, item 21 | 36,900 | 37,600 |
178 | Schedule 9, clause 5, item 22 | 450 | 460 |
179 | Schedule 9, clause 5, item 23 | 1,700 | 1,730 |
180 | Schedule 9, clause 5, item 24 | 1,830 | 1,870 |
181 | Schedule 9, clause 5, item 25 | 14,000 | 14,300 |
182 | Schedule 9, clause 5, item 26 | 1,830 | 1,870 |
183 | Schedule 9, clause 5, item 27 | 14,000 | 14,300 |
184 | Schedule 9, clause 5, item 28 | 1,090 | 1,110 |
185 | Schedule 9, clause 5, item 29 | 14,600 | 14,900 |
186 | Schedule 9, clause 5, item 30 | 1,090 | 1,110 |
187 | Schedule 9, clause 5, item 31 | 14,600 | 14,900 |
188 | Schedule 9, clause 5, item 32 | 2,880 | 2,940 |
189 | Schedule 9, clause 5, item 33 | 23,800 | 24,300 |
190 | Schedule 9, clause 5, item 34 | 2,880 | 2,940 |
191 | Schedule 9, clause 5, item 35 | 23,800 | 24,300 |
192 | Schedule 9A, Part 2, items 1, 2 and 3 | 1,110 | 1,130 |
193 | Schedule 9A, Part 2, item 3A, paragraphs (a) and (b) | 430 | 440 |
194 | Schedule 9A, Part 2, item 4 | 73,700 | 75,100 |
195 | Schedule 9A, Part 2, item 5 | 147,400 | 150,300 |
196 | Schedule 9A, Part 2, item 6 | 239,500 | 244,200 |
197 | Schedule 9A, Part 2, item 7 | 23,900 | 24,400 |
198 | Schedule 9A, Part 2, item 8 | 1,110 | 1,130 |
199 | Schedule 9A, Part 2, items 8A and 9 | 6,760 | 6,890 |
200 | Schedule 9A, Part 2, item 10 | 17,800 | 18,100 |
201 | Schedule 9A, Part 2, item 11 | 34,900 | 35,600 |
202 | Schedule 9A, Part 2, item 12 | 21,900 | 22,300 |
203 | Schedule 9A, Part 2, item 13 | 16,600 | 16,900 |
204 | Schedule 9A, Part 2, item 14 | 680 | 690 |
205 | Schedule 9A, Part 2, item 16 | 26,600 | 27,100 |
206 | Schedule 9A, Part 2, item 17, paragraphs (a) and (b) | 370 | 380 |
Therapeutic Goods (Medical Devices) Regulations 2002
3 Part 1 of Schedule 5 (table item 1.15)
Repeal the item, substitute:
1.15 | Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device: | Sections 41MA and 41MAA and paragraph 63(2)(h) of the Act |
|
| (a) for an application relating to a medical device to which a single entry in the Register relates; or |
| 490 (for all the devices to which the application relates) |
| (b) for an application relating to medical devices to which both of the following apply: (i) there are separate entries in the Register in relation to the devices; (ii) the way in which the devices do not comply with essential principles is the same for all the devices |
| 490 for the first entry plus 100 for each additional entry |
Therapeutic Goods Regulations 1990
4 Regulation 2
Insert:
medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).
5 Subregulation 45AA(1)
Omit “item 6 or 7 in Part 2 of Schedule 9 or”.
6 Subparagraph 45AA(4)(c)(ii)
Omit “decides not to register the therapeutic device or”.
7 Subparagraph 45AA(4)(c)(ii)
Omit “subsection 25(3) or”.
8 Subparagraph 45AA(4)(c)(iii)
Omit “the therapeutic device is registered or”.
9 Schedule 5A (table item 1A, column 3, subparagraph (a)(ii))
Omit “—supply”, substitute “, give”.
10 Schedule 5A (after table item 1A)
Insert:
2 | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3-3 of the Act and are held under the direct control of the sponsor, until the goods are: (a) the subject of a notification under item 3; or (b) approved for supply in Australia under subsection 19(1) or section 19A of the Act; or (c) authorised for supply under subsection 19(5) of the Act; or (d) authorised for supply under rules made under subsection 19(7A) of the Act | (a) the supply of the goods must be in accordance with the relevant notification, approval or authorisation; and (b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and (c) the sponsor must: (i) keep records relating to the source and supply of the goods; and (ii) if requested by the Secretary, give the records to the Secretary |
2A | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3-3 of the Act and are held under the direct control of the sponsor, until a decision is made under section 25 or 26 of the Act about the goods | the sponsor must: (a) keep records about the source of the goods; and (b) if requested by the Secretary, give the records to the Secretary; and (c) have lodged an application under section 23 of the Act for the goods before their manufacture |
11 Schedule 5A (table item 3, column 3, paragraph (b))
Omit “or 14A”.
12 Clause 3 of Schedule 9 (table item 1A)
Repeal the item, substitute:
1A | Application fee for processing an application for consent under section 14 or 14A of the Act: |
|
| (a) for an application relating to goods to which a single entry in the Register relates | 490 (for all the goods to which the application relates) |
| (b) for an application relating to goods to which both of the following apply: (i) there are separate entries in the Register in relation to the goods; (ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods | 490 for the first entry plus 100 for each additional entry |
13 Clause 3 of Schedule 9 (table item 1, column 2, paragraph (c))
Repeal the paragraph.
14 Clause 3 of Schedule 9 (table item 1, column 3, fee relating to paragraph (c))
Omit “18,600”.
15 Clause 3 of Schedule 9 (table item 1, column 2, paragraph (d))
Repeal the paragraph.
16 Clause 3 of Schedule 9 (table item 1, column 3, fee relating to paragraph (d))
Omit “2,800”.
17 Clause 3 of Schedule 9 (table item 2, column 2, subparagraph (d)(i))
Omit “or are therapeutic devices”.
18 Clause 3 of Schedule 9 (table item 2, column 2, paragraph (g))
Repeal the paragraph.
19 Clause 3 of Schedule 9 (table item 2, column 3, fee relating to paragraph (g))
Omit “1,490”.
20 Clause 3 of Schedule 9 (table item 2A)
Repeal the item, substitute:
2A | Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for: |
|
| (a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission | 1,740 |
| (b) a listed medicine | 440 |
| (c) a medical device | 470 |
21 Clause 3 of Schedule 9 (table item 4, column 2, paragraphs (aa) and (bb))
Omit “or a therapeutic device”.
22 Clause 3 of Schedule 9 (table items 6, 6AD, 7, 9B and 9C)
Repeal the items.
23 Clause 3 of Schedule 9 (table item 9D)
Repeal the item, substitute:
9D | Fee for evaluation, under subsection 9D(1), (2) or (3), subsection 24(1A) or paragraph 26(1)(d) of the Act, of data relating to the device component, to which Chapter 4 of the Act applies, of a medicine (in addition to the fee prescribed in item 4, or in Part 3 of this Schedule, for evaluating the medicine) | The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken |
24 Clause 3 of Schedule 9 (table item 12, column 3)
Omit “, 5, 6 or 7”, substitute “or 5”.
25 Clause 3 of Schedule 9 (table item 13, column 3)
Omit “, 5, 6 or 7”, substitute “or 5”.
26 Clause 3 of Schedule 9 (table item 14A)
Repeal the item.
27 Part 2 of Schedule 9A (after table item 11)
Insert:
11A | Application fee for processing an application for consent under section 14 or 14A of the Act: |
|
| (a) for an application relating to goods that are biologicals to which a single entry in the Register relates | 490 (for all the goods to which the application relates) |
| (b) for an application relating to goods that are biologicals to which both of the following apply: (i) there are separate entries in the Register in relation to the goods; (ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods | 490 for the first entry plus 100 for each additional entry |