Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015 (Cth)
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Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015
Select Legislative Instrument No. 87, 2015
I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation.
Dated 17 June 2015
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Fiona Nash
Assistant Minister for Health
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
1Name
This is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015.
2Commencement
(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 2015. | 1 July 2015 |
Note: This table relates only to the provisions of this instrument as originally made.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.
3Authority
This instrument is made under the Therapeutic Goods Act 1989.
4Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 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 |
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