Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024
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.
Dated 12 June 2024
David Hurley
Governor‑General
By His Excellency’s Command
Mark Butler
Minister for Health and Aged Care
Contents
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments commencing 1 July 2024
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Regulations 1990
Schedule 2—Amendments commencing 1 January 2025
Therapeutic Goods Regulations 1990
This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024.
(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. Sections 1 to 4 and anything in this instrument not elsewhere covered by this table | 1 July 2024. | 1 July 2024 |
2. Schedule 1 | 1 July 2024. | 1 July 2024 |
3. Schedule 2 | 1 January 2025. | 1 January 2025 |
Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments commencing 1 July 2024
Therapeutic Goods (Medical Devices) Regulations 2002
1 Subsection 9.1AA(1)
Omit “$30”, substitute “$31”.
2 Subsection 9.1AA(2) (method statement, step 2)
Omit “$30”, substitute “$31”.
3 Paragraph 9.7(1)(d)
After “1.14A,”, insert “1.14AA,”.
4 In the appropriate position in Part 11
Insert:
11.77 Application provision—application audit assessment fees
Table items 1.14A, 1.14AA and 1.14B of Part 1 of Schedule 5 to these Regulations, as amended or inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024, apply in relation to an application that is made on or after 1 July 2024 and in relation to which an application audit assessment fee is payable because of subsection 41LA(3) of the Act.
5 Part 2 of Schedule 4 (table item 2.3, column headed “Conditions”, paragraph (b))
Before “item 1.8”, insert “paragraph (a) of”.
6 Part 2 of Schedule 4 (table item 2.3, column headed “Conditions”, after paragraph (h))
Insert:
(ha) The notification must be accompanied by the notification fee specified in paragraph (b) of item 1.8 of Schedule 5.
7 Part 1 of Schedule 5 (table item 1.4, column headed “Amount ($)”)
After “1.14A”, insert “, 1.14AA, 1.14B or 1.14C (as the case may be)”.
8 Part 1 of Schedule 5 (table item 1.8)
Repeal the item, substitute:
1.8 | Each of the following: | Paragraph 63(2)(h) of the Act, and Schedule 4, item 2.3, paragraphs (b) and (ha) of these Regulations |
|
| (a) notification of intention to sponsor a clinical trial of a medical device, including an IVD medical device, to be used solely for experimental purposes in humans, at a trial site; |
| 429 |
| (b) each notification of an additional trial site or additional trial sites for the clinical trial |
| 429 |
9 Part 1 of Schedule 5 (at the end of paragraph (b) of table item 1.14A)
Add “, other than devices to which item 1.14AA applies”.
10 Part 1 of Schedule 5 (subparagraph (c)(ii) of table item 1.14A)
After “item”, insert “1.14AA,”.
11 Part 1 of Schedule 5 (after table item 1.14A)
Insert:
1.14AA | Application audit assessment for Class 3 IVD medical devices or Class 4 IVD medical devices (other than devices to which paragraph (d) of item 1.14A, or item 1.14C, applies), where the devices are not subject to laboratory testing as part of the auditing of the application | Subsections 41LA(3) and (4) of the Act | 14,865 |
12 Part 1 of Schedule 5 (table item 1.14B, column headed “Matter”)
After “item”, insert “1.14AA or”.
13 Paragraph 2.1(b) of Schedule 5
Omit “$474”, substitute “$496”.
14 Amendments of listed provisions—Part 1 of Schedule 5
The items of the table in Part 1 of Schedule 5 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1.1 | 1,416 | 1,483 |
2 | Item 1.1A | 10,568 | 11,065 |
3 | Item 1.2, paragraph (a) | 9,296 | 9,733 |
4 | Item 1.2, paragraph (b) | 9,347 | 9,786 |
5 | Item 1.3, paragraph (a) | 56,840 | 59,511 |
6 | Item 1.3, paragraph (b) | 43,810 | 45,869 |
7 | Item 1.3A, paragraph (a) | 32,114 | 33,623 |
8 | Item 1.3A, paragraph (b) | 68,434 | 71,650 |
9 | Item 1.3A, paragraph (c) | 16,621 | 17,402 |
10 | Item 1.3A, paragraph (d) | 4,032 | 4,222 |
11 | Item 1.3A, paragraph (e) | 44,221 | 46,299 |
12 | Item 1.3A, paragraph (f) | 28,215 | 29,541 |
13 | Item 1.4A | 5,083 | 5,322 |
14 | Items 1.4B and 1.4C | 2,795 | 2,926 |
15 | Item 1.4D | 83,002 | 86,903 |
16 | Items 1.4E and 1.4F | 59,580 | 62,380 |
17 | Item 1.5, paragraph (b) | 1,416 | 1,483 |
18 | Item 1.5, paragraphs (c) and (d) | 1,098 | 1,150 |
19 | Item 1.5, paragraph (e) | 575 | 602 |
20 | Item 1.5, paragraph (f) | 92 | 96 |
21 | Item 1.5, paragraph (g) | 575 | 602 |
22 | Item 1.5, paragraph (h) | 1,098 | 1,150 |
23 | Item 1.5, paragraph (i) | 92 | 96 |
24 | Item 1.5A | 11,118 | 11,641 |
25 | Item 1.6A, paragraphs (a) and (b) | 173 | 181 |
26 | Item 1.6A, paragraph (b) | 54 | 57 |
27 | Item 1.6B, paragraphs (a) and (b) | 173 | 181 |
28 | Item 1.6B, paragraph (b) | 54 | 57 |
29 | Item 1.7 | 20,723 | 21,697 |
30 | Item 1.7A | 5,656 | 5,922 |
31 | Item 1.9, paragraph (a) | 32,011 | 33,516 |
32 | Item 1.9, paragraph (b) | 62,894 | 65,850 |
33 | Item 1.9, paragraph (c) | 43,810 | 45,869 |
34 | Item 1.9, paragraph (d) | 30,677 | 32,119 |
35 | Item 1.9, paragraph (e) | 28,010 | 29,326 |
36 | Item 1.9, paragraph (f) | 23,906 | 25,030 |
37 | Item 1.9A, paragraph (a) | 32,114 | 33,623 |
38 | Item 1.9A, paragraph (b) | 68,434 | 71,650 |
39 | Item 1.9A, paragraph (c) | 16,621 | 17,402 |
40 | Item 1.9A, paragraph (d) | 4,032 | 4,222 |
41 | Item 1.9A, paragraph (e) | 44,221 | 46,299 |
42 | Item 1.9A, paragraph (f) | 28,215 | 29,541 |
43 | Item 1.10, paragraph (a) | 19,289 | 20,196 |
44 | Item 1.10, paragraph (b) | 37,962 | 39,746 |
45 | Item 1.10, paragraph (c) | 26,471 | 27,715 |
46 | Item 1.10, paragraph (d) | 16,621 | 17,402 |
47 | Item 1.10, paragraph (e) | 14,569 | 15,254 |
48 | Item 1.10A, paragraph (a) | 19,268 | 20,174 |
49 | Item 1.10A, paragraph (b) | 41,060 | 42,990 |
50 | Item 1.10A, paragraph (c) | 9,973 | 10,442 |
51 | Item 1.10A, paragraph (d) | 2,419 | 2,533 |
52 | Item 1.10A, paragraph (e) | 26,533 | 27,780 |
53 | Item 1.10A, paragraph (f) | 16,929 | 17,725 |
54 | Item 1.12 | 474 | 496 |
55 | Item 1.13 | 4,350 | 4,554 |
56 | Item 1.14, paragraph (a) | 16,000 | 16,752 |
57 | Item 1.14, paragraph (b) | 4,000 | 4,188 |
58 | Item 1.14A, paragraph (a) | 7,387 | 7,734 |
59 | Item 1.14A, paragraphs (b) and (c) | 22,387 | 23,439 |
60 | Item 1.14A, paragraph (d) | 16,621 | 17,402 |
61 | Item 1.14B | 22,387 | 23,439 |
62 | Item 1.14C | 16,621 | 17,402 |
63 | Item 1.15, paragraphs (a) and (b) | 540 | 565 |
64 | Item 1.15, paragraph (b) | 108 | 113 |
65 | Item 1.17 | 1,155 | 1,209 |
Therapeutic Goods Regulations 1990
15 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
| 565 (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 | 565 for the first entry plus 113 for each additional entry |
| (c) for an application relating to goods to which no entry in the Register relates | 3,712 |
16 Part 2 of Schedule 9A (table, heading to column headed “Fee”)
Repeal the heading, substitute:
Fee $
17 Amendments of listed provisions
The provisions listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Paragraph 43AAJ(1)(b) | $111,065 | $118,064 |
2 | Paragraph 43AC(2)(a) | $4,533 | $4,746 |
3 | Paragraph 43AC(2)(b) | $7,609 | $7,967 |
4 | Paragraph 43AC(2)(c) | $9,930 | $10,397 |
5 | Paragraph 43ACA(2)(aa) | $1,188 | $1,244 |
6 | Paragraph 43ACA(2)(ab) | $8,635 | $9,041 |
7 | Paragraph 43ACA(2)(a) | $4,576 | $4,791 |
8 | Paragraph 43ACA(2)(b) | $7,167 | $7,504 |
9 | Paragraph 43ACA(2)(c) | $10,588 | $11,086 |
10 | Paragraph 45(6)(a) | $1,241 | $1,299 |
11 | Paragraph 45(6)(b) | $4,954 | $5,187 |
18 Amendments of listed provisions—clause 3 of Schedule 9
The items of the table in clause 3 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1, paragraph (a) | 1,954 | 2,046 |
2 | Item 1, paragraph (b) | 24,285 | 25,426 |
3 | Item 1AAA, paragraph (a) | 537 | 562 |
4 | Item 1AAA, paragraph (b) | 6,628 | 6,940 |
5 | Item 1AA | 14,140 | 14,805 |
6 | Item 1AB | 5,127 | 5,368 |
7 | Item 1ABA | 9,347 | 9,786 |
8 | Item 1AC, paragraph (a) | 54,399 | 56,956 |
9 | Item 1AC, paragraph (b) | 32,489 | 34,016 |
10 | Item 1AD, paragraph (a) | 283,870 | 297,212 |
11 | Item 1AD, paragraph (b) | 187,268 | 196,070 |
12 | Item 1AE | 32,381 | 33,903 |
13 | Item 1AF | 136,538 | 142,955 |
14 | Item 1AG | 19,537 | 20,455 |
15 | Item 1B | 14,140 | 14,805 |
16 | Item 2, paragraph (ba) | 54,292 | 56,844 |
17 | Item 2, paragraph (bb) | 18,025 | 18,872 |
18 | Item 2, paragraph (bc) | 36,158 | 37,857 |
19 | Item 2, paragraph (bca) | 57,530 | 60,234 |
20 | Item 2, paragraph (bcb) | 1,241 | 1,299 |
21 | Item 2, paragraph (bd) | 32,381 | 33,903 |
22 | Item 2, subparagraph (be)(i) | 10,761 | 11,267 |
23 | Item 2, subparagraph (be)(ii) | 7,026 | 7,356 |
24 | Item 2, subparagraph (bf)(i) | 21,695 | 22,715 |
25 | Item 2, subparagraph (bf)(ii) | 14,032 | 14,692 |
26 | Item 2, paragraph (bfa) | 34,215 | 35,823 |
27 | Item 2, paragraph (bg) | 20,939 | 21,923 |
28 | Item 2, paragraph (bh) | 3,421 | 3,582 |
29 | Item 2, paragraph (bi) | 21,156 | 22,150 |
30 | Item 2, paragraphs (bj) and (bk) | 1,241 | 1,299 |
31 | Item 2, paragraph (c) | 4,943 | 5,175 |
32 | Item 2, paragraph (d) | 2,461 | 2,577 |
33 | Item 2, paragraph (d) | 14,356 | 15,031 |
34 | Item 2A, paragraph (a) | 1,900 | 1,989 |
35 | Item 2A, paragraph (b) | 474 | 496 |
36 | Item 2A, paragraph (c) | 1,400 | 1,466 |
37 | Item 2A, paragraph (d) | 1,750 | 1,832 |
38 | Item 2A, paragraphs (e) and (f) | 1,000 | 1,047 |
39 | Item 2A, paragraph (g) | 190 | 199 |
40 | Item 2AC | 1,241 | 1,299 |
41 | Item 2B | 6,195 | 6,486 |
42 | Item 2C | 4,954 | 5,187 |
43 | Item 2CA | 6,195 | 6,486 |
44 | Items 2CB to 2CE (wherever occurring) | 907 | 950 |
45 | Item 3, paragraph (a) | 2,200 | 2,303 |
46 | Item 3, paragraph (b) | 939 | 983 |
47 | Item 3AB, paragraphs (a) and (b) | 474 | 496 |
48 | Item 3AB, paragraph (b) | 54 | 57 |
49 | Item 4, paragraph (a) | 217,598 | 227,825 |
50 | Item 4, subparagraphs (aa)(i) and (ii) | 72,641 | 76,055 |
51 | Item 4, subparagraph (aa)(iii) | 144,742 | 151,545 |
52 | Item 4, paragraph (ab) | 230,118 | 240,934 |
53 | Item 4, paragraph (ac) | 4,954 | 5,187 |
54 | Item 4, paragraph (b) | 129,091 | 135,158 |
55 | Item 4, subparagraph (bb)(i) | 43,066 | 45,090 |
56 | Item 4, subparagraph (bb)(i) | 27,955 | 29,269 |
57 | Item 4, subparagraph (bb)(ii) | 43,066 | 45,090 |
58 | Item 4, subparagraph (bb)(ii) | 27,955 | 29,269 |
59 | Item 4, subparagraph (bb)(iii) | 86,024 | 90,067 |
60 | Item 4, subparagraph (bb)(iii) | 56,235 | 58,878 |
61 | Item 4, paragraph (bc) | 4,954 | 5,187 |
62 | Item 4, paragraph (bd) | 136,862 | 143,295 |
63 | Item 4, paragraph (c) | 83,110 | 87,016 |
64 | Item 4, paragraph (d) | 13,600 | 14,239 |
65 | Item 4, paragraph (g) | 84,189 | 88,146 |
66 | Item 4, paragraph (h) | 4,954 | 5,187 |
67 | Item 6AA | 723 | 757 |
68 | Item 6AB | 777 | 814 |
69 | Item 6ABA | 2,764 | 2,894 |
70 | Item 6AC | 1,306 | 1,367 |
71 | Item 6B | 4,155 | 4,350 |
72 | Item 6BA, paragraphs (a) and (b) | 173 | 181 |
73 | Item 6BA, paragraph (b) | 54 | 57 |
74 | Item 6BB, paragraphs (a) and (b) | 173 | 181 |
75 | Item 6BB, paragraph (b) | 54 | 57 |
76 | Item 6C | 9,023 | 9,447 |
77 | Item 6D, paragraph (a) | 11,873 | 12,431 |
78 | Item 6D, paragraph (b) | 15,327 | 16,047 |
79 | Item 6D, paragraph (c) | 20,939 | 21,923 |
80 | Item 6D, paragraph (d) | 27,739 | 29,043 |
81 | Item 6D, paragraph (e) | 41,555 | 43,508 |
82 | Item 6D, paragraph (f) | 55,371 | 57,973 |
83 | Item 6D, paragraph (g) | 83,110 | 87,016 |
84 | Item 7A, paragraph (a) | 11,873 | 12,431 |
85 | Item 7A, subparagraph (b)(i) | 11,873 | 12,431 |
86 | Item 7A, subparagraph (b)(ii) | 15,327 | 16,047 |
87 | Item 7A, subparagraph (b)(iii) | 20,939 | 21,923 |
88 | Item 7A, subparagraph (b)(iv) | 27,739 | 29,043 |
89 | Item 7A, subparagraph (b)(v) | 41,555 | 43,508 |
90 | Item 7A, subparagraph (b)(vi) | 55,371 | 57,973 |
91 | Item 7A, subparagraph (b)(vii) | 83,110 | 87,016 |
92 | Item 7B, paragraph (a) | 11,873 | 12,431 |
93 | Item 7B, subparagraph (b)(i) | 11,873 | 12,431 |
94 | Item 7B, subparagraph (b)(ii) | 15,327 | 16,047 |
95 | Item 7B, subparagraph (b)(iii) | 20,939 | 21,923 |
96 | Item 7B, subparagraph (b)(iv) | 27,739 | 29,043 |
97 | Item 7B, subparagraph (b)(v) | 41,555 | 43,508 |
98 | Item 7B, subparagraph (b)(vi) | 55,371 | 57,973 |
99 | Item 7B, subparagraph (b)(vii) | 83,110 | 87,016 |
100 | Item 7C | 1,176 | 1,231 |
101 | Item 8, paragraph (a) | 885 | 927 |
102 | Item 8, paragraph (b) | 1,155 | 1,209 |
103 | Items 8A to 8C | 855 | 927 |
104 | Item 9, paragraph (a) | 1,101 | 1,153 |
105 | Item 9, paragraph (b) | 1,543 | 1,616 |
106 | Item 9AA | 755 | 790 |
107 | Item 9AB | 1,026 | 1,074 |
108 | Items 9AC and 9ACA | 755 | 790 |
109 | Item 9AD, paragraph (a) | 1,490 | 1,560 |
110 | Item 9AD, paragraph (b) | 12,628 | 13,222 |
111 | Item 9AD, paragraph (c) | 28,494 | 29,833 |
112 | Item 9AD, paragraph (d) | 38,317 | 40,118 |
113 | Item 9AD, paragraph (e) | 59,688 | 62,493 |
114 | Item 9AD, paragraph (f) | 79,548 | 83,287 |
115 | Item 9AD, paragraph (g) | 97,033 | 101,594 |
116 | Item 10 | 195 | 204 |
117 | Item 14, paragraphs (a) and (b) | 410 | 429 |
118 | Item 18 | 2,504 | 2,622 |
19 Amendments of listed provisions—clause 4 of Schedule 9
The items of the table in clause 4 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1, paragraphs (a) and (b) | 1,835 | 1,921 |
2 | Item 1, paragraph (c) | 2,947 | 3,086 |
3 | Item 1, paragraph (d) | 4,307 | 4,509 |
4 | Item 1, paragraph (e) | 6,379 | 6,679 |
5 | Item 1, paragraphs (f) to (h) | 1,835 | 1,921 |
6 | Item 1, paragraph (i) | 2,947 | 3,086 |
7 | Item 2, paragraph (a) | 4,533 | 4,746 |
8 | Item 2, paragraph (b) | 6,444 | 6,747 |
9 | Item 2, paragraph (c) | 9,930 | 10,397 |
10 | Item 2, paragraph (d) | 16,514 | 17,290 |
11 | Item 2, paragraph (e) | 24,285 | 25,426 |
12 | Item 2, paragraph (f) | 4,533 | 4,746 |
13 | Item 2, paragraph (g) | 7,609 | 7,967 |
14 | Item 2, paragraph (h) | 9,930 | 10,397 |
15 | Item 3, paragraphs (d) and (e) | 928 | 972 |
16 | Item 3, paragraphs (f) to (h) | 1,479 | 1,549 |
17 | Item 4, paragraphs (d) to (f) | 5,030 | 5,266 |
18 | Item 5, paragraph (a) | 1,835 | 1,921 |
19 | Item 5, paragraph (b) | 6,379 | 6,679 |
20 | Item 5, paragraph (c) | 9,455 | 9,899 |
21 | Item 5, paragraph (d) | 12,844 | 13,448 |
22 | Item 7, paragraph (a) | 1,802 | 1,887 |
23 | Item 7, paragraph (b) | 9,240 | 9,674 |
20 Amendments of listed provisions—clause 5 of Schedule 9
The items of the table in clause 5 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1A | 2,212 | 2,316 |
2 | Item 1B | 9,661 | 10,115 |
3 | Item 1C | 885 | 927 |
4 | Items 1D and 1E | 1,026 | 1,074 |
5 | Item 1F | 885 | 927 |
6 | Item 1G | 1,188 | 1,244 |
7 | Item 1H | 8,635 | 9,041 |
8 | Item 1 | 1,609 | 1,685 |
9 | Item 2 | 5,429 | 5,684 |
10 | Item 3 | 8,063 | 8,442 |
11 | Item 4 | 11,442 | 11,980 |
12 | Item 5 | 1,609 | 1,685 |
13 | Item 6 | 842 | 882 |
14 | Item 7 | 4,576 | 4,791 |
15 | Item 8 | 907 | 950 |
16 | Item 9 | 7,167 | 7,504 |
17 | Item 10 | 928 | 972 |
18 | Item 11 | 10,588 | 11,086 |
19 | Item 12 | 615 | 644 |
20 | Item 13 | 3,529 | 3,695 |
21 | Item 14 | 2,212 | 2,316 |
22 | Item 15 | 23,637 | 24,748 |
23 | Item 16 | 2,212 | 2,316 |
24 | Item 17 | 23,637 | 24,748 |
25 | Item 18 | 2,925 | 3,062 |
26 | Item 19 | 32,165 | 33,677 |
27 | Item 20 | 3,205 | 3,356 |
28 | Item 21 | 41,015 | 42,943 |
29 | Item 22 | 497 | 520 |
30 | Item 23 | 1,889 | 1,978 |
31 | Item 24 | 2,040 | 2,136 |
32 | Item 25 | 15,651 | 16,387 |
33 | Item 26 | 2,040 | 2,136 |
34 | Item 27 | 15,651 | 16,387 |
35 | Item 28 | 1,209 | 1,266 |
36 | Item 29 | 16,299 | 17,065 |
37 | Item 30 | 1,209 | 1,266 |
38 | Item 31 | 16,299 | 17,065 |
39 | Item 32 | 3,205 | 3,356 |
40 | Item 33 | 26,552 | 27,800 |
41 | Item 34 | 3,205 | 3,356 |
42 | Item 35 | 26,552 | 27,800 |
21 Amendments of listed provisions—Part 2 of Schedule 9A
The items of the table in Part 2 of Schedule 9A listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Items 1 to 2AA | $1,231 | 1,289 |
2 | Item 2A | $14,697 | 15,388 |
3 | Item 3 | $1,231 | 1,289 |
4 | Item 3A, paragraphs (a) and (b) | $474 | 496 |
5 | Item 3A, paragraph (b) | $54 | 57 |
6 | Item 4, paragraph (a) | $85,630 | 89,655 |
7 | Item 4, paragraph (b) | $81,922 | 85,772 |
8 | Item 5, paragraph (a) | $171,683 | 179,752 |
9 | Item 5, paragraph (b) | $163,953 | 171,659 |
10 | Item 6, paragraph (a) | $277,423 | 290,462 |
11 | Item 6, paragraph (b) | $266,384 | 278,904 |
12 | Item 7 | $26,660 | 27,913 |
13 | Item 8 | $1,231 | 1,289 |
14 | Items 8A and 9 | $7,512 | 7,865 |
15 | Item 10 | $19,752 | 20,680 |
16 | Item 11 | $38,857 | 40,683 |
17 | Item 11A, paragraphs (a) and (b) | $540 | 565 |
18 | Item 11A, paragraph (b) | $108 | 113 |
19 | Item 12 | $24,285 | 25,426 |
20 | Item 13 | $18,457 | 19,324 |
21 | Item 14 | $755 | 790 |
22 | Item 16 | $29,574 | 30,964 |
23 | Item 16AA | $8,069 | $8,448 |
24 | Item 16A, paragraphs (a) and (b) | $173 | 181 |
25 | Item 16A, paragraph (b) | $54 | 57 |
26 | Item 16B, paragraphs (a) and (b) | $173 | 181 |
27 | Item 16B, paragraph (b) | $54 | 57 |
28 | Item 17, paragraphs (a) and (b) | $410 | 429 |
Schedule 2—Amendments commencing 1 January 2025
Therapeutic Goods Regulations 1990
1 Clause 3 of Schedule 9 (after table item 1AF)
Insert:
1AFA | Fee for the purposes of subsection 28(3A) of the Act for a request under that subsection: |
|
| (a) if the request relates to therapeutic goods that are specified in Part 1 of Schedule 10 to these Regulations | 2,879 |
| (b) if the request relates to any other therapeutic goods not covered by paragraph (a) of this item | 1,790 |
2 Part 2 of Schedule 9A (after table item 2A)
Insert:
2B | Fee for the purposes of subsection 32EE(2) of the Act for a request under that subsection. | 2,010 |