Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022 (Cth)
Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022
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 10 April 2022
David Hurley
Governor‑General
By His Excellency’s Command
Greg Hunt
Minister for Health and Aged Care
Contents
1............ Name............................................................................................................................. 1
2............ Commencement............................................................................................................. 1
3............ Authority....................................................................................................................... 1
4............ Schedules...................................................................................................................... 1
Schedule 1—Amendments 2
Therapeutic Goods (Medical Devices) Regulations 2002 2
Therapeutic Goods Regulations 1990 3
1 Name
This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2022.
2 Commencement
(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 2022. | 1 July 2022 |
Note: This table relates only to the provisions of this instrument as originally made.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.
3 Authority
This instrument is made under the Therapeutic Goods Act 1989.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 (Medical Devices) Regulations 2002
1 Subregulation 4A.6(2)
Omit all the words after “Schedule 3AA”.
2 Part 1 of Schedule 5 (after table item 1.7)
Insert:
| 1.7A | Request to vary a medical device, or kind of medical device, specified in an approval to use that device or kind of device solely for experimental purposes in humans, or to vary the conditions of such an approval | Paragraph 41HB(8)(e) of the Act | 5,376 |
3 Paragraph 2.1(b) of Part 2 of Schedule 5
Omit “$440”, substitute “$451”.
4 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 | 1,050 | 1,077 |
| 2 | Item 1.1A | 10,300 | 10,568 |
| 3 | Item 1.2, paragraph (a) | 9,060 | 9,296 |
| 4 | Item 1.2, paragraph (b) | 9,110 | 9,347 |
| 5 | Item 1.3, paragraph (a) | 55,400 | 56,840 |
| 6 | Item 1.3, paragraph (b) | 42,700 | 43,810 |
| 7 | Item 1.3A, paragraph (a) | 31,300 | 32,114 |
| 8 | Item 1.3A, paragraph (b) | 66,700 | 68,434 |
| 9 | Item 1.3A, paragraph (c) | 16,200 | 16,621 |
| 10 | Item 1.3A, paragraph (d) | 3,930 | 4,032 |
| 11 | Item 1.3A, paragraph (e) | 43,100 | 44,221 |
| 12 | Item 1.3A, paragraph (f) | 27,500 | 28,215 |
| 13 | Item 1.4A | 4,710 | 4,832 |
| 14 | Items 1.4B and 1.4C | 2,590 | 2,657 |
| 15 | Item 1.4D | 76,900 | 78,899 |
| 16 | Items 1.4E and 1.4F | 55,200 | 56,635 |
| 17 | Item 1.5, paragraph (b) | 1,380 | 1,416 |
| 18 | Item 1.5, paragraphs (c) to (e) | 1,070 | 1,098 |
| 19 | Item 1.5, paragraph (f) | 90 | 92 |
| 20 | Item 1.5, paragraph (g) | 560 | 575 |
| 21 | Item 1.5, paragraph (h) | 1,070 | 1,098 |
| 22 | Item 1.5, paragraph (i) | 90 | 92 |
| 23 | Item 1.5A | 10,300 | 10,568 |
| 24 | Item 1.6A, paragraphs (a) and (b) | 160 | 164 |
| 25 | Item 1.6A, paragraph (b) | 50 | 51 |
| 26 | Item 1.6B, paragraphs (a) and (b) | 160 | 164 |
| 27 | Item 1.6B, paragraph (b) | 50 | 51 |
| 28 | Item 1.7 | 19,200 | 19,699 |
| 29 | Item 1.8 | 380 | 390 |
| 30 | Item 1.9, paragraph (a) | 31,200 | 32,011 |
| 31 | Item 1.9, paragraph (b) | 61,300 | 62,894 |
| 32 | Item 1.9, paragraph (c) | 42,700 | 43,810 |
| 33 | Item 1.9, paragraph (d) | 29,900 | 30,677 |
| 34 | Item 1.9, paragraph (e) | 27,300 | 28,010 |
| 35 | Item 1.9, paragraph (f) | 23,300 | 23,906 |
| 36 | Item 1.9A, paragraph (a) | 31,300 | 32,114 |
| 37 | Item 1.9A, paragraph (b) | 66,700 | 68,434 |
| 38 | Item 1.9A, paragraph (c) | 16,200 | 16,621 |
| 39 | Item 1.9A, paragraph (d) | 3,930 | 4,032 |
| 40 | Item 1.9A, paragraph (e) | 43,100 | 44,221 |
| 41 | Item 1.9A, paragraph (f) | 27,500 | 28,215 |
| 42 | Item 1.10, paragraph (a) | 18,800 | 19,289 |
| 43 | Item 1.10, paragraph (b) | 37,000 | 37,962 |
| 44 | Item 1.10, paragraph (c) | 25,800 | 26,471 |
| 45 | Item 1.10, paragraph (d) | 16,200 | 16,621 |
| 46 | Item 1.10, paragraph (e) | 14,200 | 14,569 |
| 47 | Item 1.12 | 440 | 451 |
| 48 | Item 1.13 | 4,030 | 4,135 |
| 49 | Item 1.14 | 7,390 | 7,582 |
| 50 | Item 1.14A | 7,200 | 7,387 |
| 51 | Item 1.14B | 66,700 | 68,434 |
| 52 | Item 1.14C | 16,200 | 16,621 |
| 53 | Item 1.15, paragraphs (a) and (b) | 500 | 513 |
| 54 | Item 1.15, paragraph (b) | 100 | 103 |
| 55 | Item 1.17 | 1,070 | 1,098 |
Therapeutic Goods Regulations 1990
5 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) | 102,900 | 105,575 |
| 2 | Paragraph 43AC(2)(a) | 4,200 | 4,309 |
| 3 | Paragraph 43AC(2)(b) | 7,050 | 7,233 |
| 4 | Paragraph 43AC(2)(c) | 9,200 | 9,439 |
| 5 | Paragraph 43ACA(2)(aa) | 1,100 | 1,129 |
| 6 | Paragraph 43ACA(2)(ab) | 8,000 | 8,208 |
| 7 | Paragraph 43ACA(2)(a) | 4,240 | 4,350 |
| 8 | Paragraph 43ACA(2)(b) | 6,640 | 6,813 |
| 9 | Paragraph 43ACA(2)(c) | 9,810 | 10,065 |
| 10 | Paragraph 45(6)(a) | 1,150 | 1,180 |
| 11 | Paragraph 45(6)(b) | 4,590 | 4,709 |
6 Clause 3 of Schedule 9 (after table item 1)
Insert:
| 1AAA | Fee for the purposes of paragraph 19(4B)(e) of the Act, for a request under subsection 19(4B) to vary the therapeutic goods specified in an approval to use those goods solely for experimental purposes in humans, or to vary the conditions of such an approval: |
| (a) if the request relates to: (i) goods that are medicines; and (ii) paragraph (a) of item 1 applied to the evaluation of the application for approval | 510 |
| (b) if the request relates to: (i) goods that are medicines; and (ii) paragraph (b) of item 1 applied to the evaluation of the application for approval | 6,300 |
7 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 1A, paragraphs (a) and (b) | 500 | 513 |
| 2 | Item 1A, paragraph (b) | 100 | 103 |
| 3 | Item 1, paragraph (a) | 1,810 | 1,857 |
| 4 | Item 1, paragraph (b) | 22,500 | 23,085 |
| 5 | Item 1AA | 13,100 | 13,441 |
| 6 | Item 1AB | 4,750 | 4,874 |
| 7 | Item 1ABA | 8,660 | 8,885 |
| 8 | Item 1AC, paragraph (a) | 50,400 | 51,710 |
| 9 | Item 1AC, paragraph (b) | 30,100 | 30,883 |
| 10 | Item 1AD, paragraph (a) | 263,000 | 269,838 |
| 11 | Item 1AD, paragraph (b) | 173,500 | 178,011 |
| 12 | Item 1AE | 30,000 | 30,780 |
| 13 | Item 1AF | 126,500 | 129,789 |
| 14 | Item 1AG | 18,100 | 18,571 |
| 15 | Item 1B | 13,100 | 13,441 |
| 16 | Item 2, paragraph (ba) | 50,300 | 51,608 |
| 17 | Item 2, paragraph (bb) | 16,700 | 17,134 |
| 18 | Item 2, paragraph (bc) | 33,500 | 34,371 |
| 19 | Item 2, paragraph (bca) | 53,300 | 54,686 |
| 20 | Item 2, paragraph (bd) | 30,000 | 30,780 |
| 21 | Item 2, subparagraph (be)(i) | 9,970 | 10,229 |
| 22 | Item 2, subparagraph (be)(ii) | 6,510 | 6,679 |
| 23 | Item 2, subparagraph (bf)(i) | 20,100 | 20,623 |
| 24 | Item 2, subparagraph (bf)(ii) | 13,000 | 13,338 |
| 25 | Item 2, paragraph (bfa) | 31,700 | 32,524 |
| 26 | Item 2, paragraph (bg) | 19,400 | 19,904 |
| 27 | Item 2, paragraph (bh) | 3,170 | 3,252 |
| 28 | Item 2, paragraph (bi) | 19,600 | 20,110 |
| 29 | Item 2, paragraphs (bj) and (bk) | 1,150 | 1,180 |
| 30 | Item 2, paragraph (c) | 4,580 | 4,699 |
| 31 | Item 2, paragraph (d) | 2,280 | 2,339 |
| 32 | Item 2, paragraph (d) | 13,300 | 13,646 |
| 33 | Item 2A, paragraph (a) | 1,760 | 1,806 |
| 34 | Item 2A, paragraph (b) | 440 | 451 |
| 35 | Item 2A, paragraphs (ba) and (c) | 470 | 482 |
| 36 | Item 2AB | 450 | 462 |
| 37 | Item 2AC | 1,150 | 1,180 |
| 38 | Item 2B | 5,740 | 5,889 |
| 39 | Item 2C | 4,590 | 4,709 |
| 40 | Item 2CA | 5,740 | 5,889 |
| 41 | Items 2CB to 2CE (wherever occurring) | 840 | 862 |
| 42 | Item 3, paragraph (a) | 470 | 482 |
| 43 | Item 3, paragraph (b) | 870 | 893 |
| 44 | Item 3AB, paragraphs (a) and (b) | 440 | 451 |
| 45 | Item 3AB, paragraph (b) | 50 | 51 |
| 46 | Item 4, paragraph (a) | 201,600 | 206,842 |
| 47 | Item 4, subparagraphs (aa)(i) and (ii) | 67,300 | 69,050 |
| 48 | Item 4, subparagraph (aa)(iii) | 134,100 | 137,587 |
| 49 | Item 4, paragraph (ab) | 213,200 | 218,743 |
| 50 | Item 4, paragraph (b) | 119,600 | 122,710 |
| 51 | Item 4, subparagraph (bb)(i) | 39,900 | 40,937 |
| 52 | Item 4, subparagraph (bb)(i) | 25,900 | 26,573 |
| 53 | Item 4, subparagraph (bb)(ii) | 39,900 | 40,937 |
| 54 | Item 4, subparagraph (bb)(ii) | 25,900 | 26,573 |
| 55 | Item 4, subparagraph (bb)(iii) | 79,700 | 81,772 |
| 56 | Item 4, subparagraph (bb)(iii) | 52,100 | 53,455 |
| 57 | Item 4, paragraph (bc) | 4,590 | 4,709 |
| 58 | Item 4, paragraph (bd) | 126,800 | 130,097 |
| 59 | Item 4, paragraph (c) | 77,000 | 79,002 |
| 60 | Item 4, paragraph (d) | 12,600 | 12,928 |
| 61 | Item 4, paragraph (g) | 78,000 | 80,028 |
| 62 | Item 4, paragraph (h) | 4,590 | 4,709 |
| 63 | Item 6AA | 670 | 687 |
| 64 | Item 6AB | 720 | 739 |
| 65 | Item 6ABA | 2,560 | 2,627 |
| 66 | Item 6AC | 1,210 | 1,241 |
| 67 | Item 6B | 3,850 | 3,950 |
| 68 | Item 6BA, paragraphs (a) and (b) | 160 | 164 |
| 69 | Item 6BA, paragraph (b) | 50 | 51 |
| 70 | Item 6BB, paragraphs (a) and (b) | 160 | 164 |
| 71 | Item 6BB, paragraph (b) | 50 | 51 |
| 72 | Item 6C | 8,360 | 8,577 |
| 73 | Item 6D, paragraph (a) | 11,000 | 11,286 |
| 74 | Item 6D, paragraph (b) | 14,200 | 14,569 |
| 75 | Item 6D, paragraph (c) | 19,400 | 19,904 |
| 76 | Item 6D, paragraph (d) | 25,700 | 26,368 |
| 77 | Item 6D, paragraph (e) | 38,500 | 39,501 |
| 78 | Item 6D, paragraph (f) | 51,300 | 52,634 |
| 79 | Item 6D, paragraph (g) | 77,000 | 79,002 |
| 80 | Item 7A, paragraph (a) | 11,000 | 11,286 |
| 81 | Item 7A, subparagraph (b)(i) | 11,000 | 11,286 |
| 82 | Item 7A, subparagraph (b)(ii) | 14,200 | 14,569 |
| 83 | Item 7A, subparagraph (b)(iii) | 19,400 | 19,904 |
| 84 | Item 7A, subparagraph (b)(iv) | 25,700 | 26,368 |
| 85 | Item 7A, subparagraph (b)(v) | 38,500 | 39,501 |
| 86 | Item 7A, subparagraph (b)(vi) | 51,300 | 52,634 |
| 87 | Item 7A, subparagraph (b)(vii) | 77,000 | 79,002 |
| 88 | Item 7B, paragraph (a) | 11,000 | 11,286 |
| 89 | Item 7B, subparagraph (b)(i) | 11,000 | 11,286 |
| 90 | Item 7B, subparagraph (b)(ii) | 14,200 | 14,569 |
| 91 | Item 7B, subparagraph (b)(iii) | 19,400 | 19,904 |
| 92 | Item 7B, subparagraph (b)(iv) | 25,700 | 26,368 |
| 93 | Item 7B, subparagraph (b)(v) | 38,500 | 39,501 |
| 94 | Item 7B, subparagraph (b)(vi) | 51,300 | 52,634 |
| 95 | Item 7B, subparagraph (b)(vii) | 77,000 | 79,002 |
| 96 | Item 7C | 1,090 | 1,118 |
| 97 | Item 8, paragraph (a) | 820 | 841 |
| 98 | Item 8, paragraph (b) | 1,070 | 1,098 |
| 99 | Items 8A to 8C | 820 | 841 |
| 100 | Item 9, paragraph (a) | 1,020 | 1,047 |
| 101 | Item 9, paragraph (b) | 1,430 | 1,467 |
| 102 | Item 9AA | 700 | 718 |
| 103 | Item 9AB | 950 | 975 |
| 104 | Items 9AC and 9ACA | 700 | 718 |
| 105 | Item 9AD, paragraph (a) | 1,380 | 1,416 |
| 106 | Item 9AD, paragraph (b) | 11,700 | 12,004 |
| 107 | Item 9AD, paragraph (c) | 26,400 | 27,086 |
| 108 | Item 9AD, paragraph (d) | 35,500 | 36,423 |
| 109 | Item 9AD, paragraph (e) | 55,300 | 56,738 |
| 110 | Item 9AD, paragraph (f) | 73,700 | 75,616 |
| 111 | Item 9AD, paragraph (g) | 89,900 | 92,237 |
| 112 | Item 9B | 19,200 | 19,699 |
| 113 | Item 10 | 180 | 185 |
| 114 | Item 14, paragraphs (a) and (b) | 380 | 390 |
| 115 | Item 18 | 2,320 | 2,380 |
8 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) | 1,700 | 1,744 |
| 2 | Item 1, paragraph (c) | 2,730 | 2,801 |
| 3 | Item 1, paragraph (d) | 3,990 | 4,094 |
| 4 | Item 1, paragraph (e) | 5,910 | 6,064 |
| 5 | Item 1, paragraphs (f) to (h) | 1,700 | 1,744 |
| 6 | Item 1, paragraph (i) | 2,730 | 2,801 |
| 7 | Item 2, paragraph (a) | 4,200 | 4,309 |
| 8 | Item 2, paragraph (b) | 5,970 | 6,125 |
| 9 | Item 2, paragraph (c) | 9,200 | 9,439 |
| 10 | Item 2, paragraph (d) | 15,300 | 15,698 |
| 11 | Item 2, paragraph (e) | 22,500 | 23,085 |
| 12 | Item 2, paragraph (f) | 4,200 | 4,309 |
| 13 | Item 2, paragraph (g) | 7,050 | 7,233 |
| 14 | Item 2, paragraph (h) | 9,200 | 9,439 |
| 15 | Item 3, paragraphs (d) and (e) | 860 | 882 |
| 16 | Item 3, paragraphs (f) to (h) | 1,370 | 1,406 |
| 17 | Item 4, paragraphs (d) to (f) | 4,660 | 4,781 |
| 18 | Item 5, paragraph (a) | 1,700 | 1,744 |
| 19 | Item 5, paragraph (b) | 5,910 | 6,064 |
| 20 | Item 5, paragraph (c) | 8,760 | 8,988 |
| 21 | Item 5, paragraph (d) | 11,900 | 12,209 |
| 22 | Item 7, paragraph (a) | 1,670 | 1,713 |
| 23 | Item 7, paragraph (b) | 8,560 | 8,783 |
9 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 | 2,050 | 2,103 |
| 2 | Item 1B | 8,950 | 9,183 |
| 3 | Item 1C | 820 | 841 |
| 4 | Items 1D and 1E | 950 | 975 |
| 5 | Item 1F | 820 | 841 |
| 6 | Item 1G | 1,100 | 1,129 |
| 7 | Item 1H | 8,000 | 8,208 |
| 8 | Item 1 | 1,490 | 1,529 |
| 9 | Item 2 | 5,030 | 5,161 |
| 10 | Item 3 | 7,470 | 7,664 |
| 11 | Item 4 | 10,600 | 10,876 |
| 12 | Item 5 | 1,490 | 1,529 |
| 13 | Item 6 | 780 | 800 |
| 14 | Item 7 | 4,240 | 4,350 |
| 15 | Item 8 | 840 | 862 |
| 16 | Item 9 | 6,640 | 6,813 |
| 17 | Item 10 | 860 | 882 |
| 18 | Item 11 | 9,810 | 10,065 |
| 19 | Item 12 | 570 | 585 |
| 20 | Item 13 | 3,270 | 3,355 |
| 21 | Item 14 | 2,050 | 2,103 |
| 22 | Item 15 | 21,900 | 22,469 |
| 23 | Item 16 | 2,050 | 2,103 |
| 24 | Item 17 | 21,900 | 22,469 |
| 25 | Item 18 | 2,710 | 2,780 |
| 26 | Item 19 | 29,800 | 30,575 |
| 27 | Item 20 | 2,970 | 3,047 |
| 28 | Item 21 | 38,000 | 38,988 |
| 29 | Item 22 | 460 | 472 |
| 30 | Item 23 | 1,750 | 1,796 |
| 31 | Item 24 | 1,890 | 1,939 |
| 32 | Item 25 | 14,500 | 14,877 |
| 33 | Item 26 | 1,890 | 1,939 |
| 34 | Item 27 | 14,500 | 14,877 |
| 35 | Item 28 | 1,120 | 1,149 |
| 36 | Item 29 | 15,100 | 15,493 |
| 37 | Item 30 | 1,120 | 1,149 |
| 38 | Item 31 | 15,100 | 15,493 |
| 39 | Item 32 | 2,970 | 3,047 |
| 40 | Item 33 | 24,600 | 25,240 |
| 41 | Item 34 | 2,970 | 3,047 |
| 42 | Item 35 | 24,600 | 25,240 |
10 Part 2 of Schedule 9A (after table item 16)
Insert:
| 16AA | Fee for the purposes of paragraph 32CK(9A)(e) of the Act, for a request under subsection 32CK(9A) of the Act to vary the biological specified in an approval to use the biological solely for experimental purposes in humans, or to vary the conditions of such an approval | $7,670 |
11 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 3 | 1,140 | 1,170 |
| 2 | Item 3A, paragraphs (a) and (b) | 440 | 451 |
| 3 | Item 3A, paragraph (b) | 50 | 51 |
| 4 | Item 4 | 75,900 | 77,873 |
| 5 | Item 5 | 151,900 | 155,849 |
| 6 | Item 6 | 246,800 | 253,217 |
| 7 | Item 7 | 24,700 | 25,342 |
| 8 | Item 8 | 1,140 | 1,170 |
| 9 | Items 8A and 9 | 6,960 | 7,141 |
| 10 | Item 10 | 18,300 | 18,776 |
| 11 | Item 11 | 36,000 | 36,936 |
| 12 | Item 11A, paragraphs (a) and (b) | 500 | 513 |
| 13 | Item 11A, paragraph (b) | 100 | 103 |
| 14 | Item 12 | 22,500 | 23,085 |
| 15 | Item 13 | 17,100 | 17,545 |
| 16 | Item 14 | 700 | 718 |
| 17 | Item 16 | 27,400 | 28,112 |
| 18 | Item 16A, paragraphs (a) and (b) | 160 | 164 |
| 19 | Item 16A, paragraph (b) | 50 | 51 |
| 20 | Item 16B, paragraphs (a) and (b) | 160 | 164 |
| 21 | Item 16B, paragraph (b) | 50 | 51 |
| 22 | Item 17, paragraphs (a) and (b) | 380 | 390 |
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