Therapeutic Goods Amendment Regulations 2007 (No. 1) (Cth)
Therapeutic Goods Amendment Regulations 2007 (No. 1)1
Select Legislative Instrument 2007 No. 161
I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.
Dated 21 June 2007
P. M. JEFFERY
Governor‑General
By His Excellency’s Command
BRETT MASON
Parliamentary Secretary to the Minister for Health and Ageing
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Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2007 (No. 1).
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Commencement
These Regulations commence on 1 July 2007.
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Amendment of Therapeutic Goods Regulations 1990
Schedule 1 amends the Therapeutic Goods Regulations 1990.
Schedule 1 Amendments
(regulation 3)
[1] Regulation 45 — amendment of fees
| Provision | omit | insert |
| Paragraph 45 (4A) (a) | $7 620; | $7 920; |
| Paragraphs 45 (4A) (b), (c) and (ca) | $6 350; | $6 600; |
| Paragraph 45 (4A) (d) | $25 500; | $26 500; |
| Paragraph 45 (4A) (e) | $6 350; | $6 600; |
| Paragraph 45 (4A) (f) | $6 350. | $6 600. |
| Paragraphs 45 (9) (a) to (d) | $3 820; | $3 970; |
| Paragraphs 45 (9) (e) | $3 820. | $3 970. |
| Paragraphs 45 (11) (a) to (d) | $1 400; | $1 460; |
| Paragraph 45 (11) (e) | $1 400. | $1 460. |
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Regulation 45A, heading
substitute
45ACharges reduced if annual turnover is not more than $71 000
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Subregulation 45A (1)
omit
$68 300
insert
$71 000
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Schedule 9, Part 2, item 6AA
omit
evaluation
insert
processing
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Schedule 9, Part 2, after item 6AB
insert
| 6ABA | Fee for desk audit of overseas compliance certification to identify third party certifications and review the overseas compliance certification by examining the underlying audit report and obtaining information from the overseas regulators | 1 500 |
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Schedule 9, Part 2, item 6AC
omit
item 6AA
insert
items 6AA and 6ABA
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Schedule 9, Part 2 — amendment of fees
| Provision | omit | insert |
| Item 1A | 330 | 340 |
| Item 1, paragraph (c) | 12 700 | 13 200 |
| Item 1, paragraph (d) | 1 910 | 1 990 |
| Item 2, paragraph (a) | 950 | 990 |
| Item 2, paragraph (b) | 1 010 | 1 050 |
| Item 2, paragraph (ba) | 6 620; | 6 880; |
| Item 2, paragraph (c) | 3 050 | 3 170 |
| Item 2, paragraph (d) | 1 520 | 1 580 |
| Item 2, paragraph (d) | $8 870 | $9 220 |
| Item 2, paragraph (f) | 420 | 440 |
| Item 2, paragraph (g) | 1 010 | 1 050 |
| Item 2, paragraph (h) | 520 | 540 |
| Item 2AA | 700 | 480 |
| Item 2A, paragraph (a) | 1 250 | 1 200 |
| Item 2A, paragraph (b) | 950 | 990 |
| Item 2A, paragraph (c) | 260 | 270 |
| Item 2A, paragraph (d) | 520 | 330 |
| Item 2A, paragraph (e) | 1 010 | 330 |
| Item 2A, paragraphs (f) and (g) | 310 | 330 |
| Items 2B and 2C | 4 230 | 3 880 |
| Item 3, paragraph (a) | 310 | 330 |
| Item 3, paragraph (b) | 520 | 540 |
| Item 3AA | 360 | 480 |
| Item 4, paragraph (a) | 178 000 | 170 200 |
| Item 4, paragraph (b) | 105 800 | 101 200 |
| Item 4, paragraph (d) | 11 200 | 10 700 |
| Item 4, paragraph (e) | 4 060 | 3 880 |
| Item 4, paragraph (f) | 1 250 | 1 200 |
| Item 4, paragraph (g) | 69 000 | 65 900 |
| Item 4, paragraph (h) | 4 230 | 3 880 |
| Item 5, paragraph (a) | 6 320 | 6 570 |
| Item 5, subparagraph (b) (i) | 6 320 | 6 570 |
| Item 5, subparagraph (b) (ii) | 8 100 | 8 420 |
| Item 5, subparagraph (b) (iii) | 11 100 | 11 500 |
| Item 5, subparagraph (b) (iv) | 14 800 | 15 400 |
| Item 5, subparagraph (b) (v) | 22 100 | 23 000 |
| Item 5, subparagraph (b) (vi) | 29 500 | 30 700 |
| Item 5, subparagraph (b) (vii) | 44 200 | 46 000 |
| Item 5, paragraph (c) | 2 280 | 2 370 |
| Item 5, subparagraph (d) (i) | 2 280 | 2 370 |
| Item 5, subparagraph (d) (ii) | 8 100 | 8 420 |
| Item 5, subparagraph (d) (iii) | 11 100 | 11 500 |
| Item 5, subparagraph (d) (iv) | 14 800 | 15 400 |
| Item 5, subparagraph (d) (v) | 22 100 | 23 000 |
| Item 5, subparagraph (d) (vi) | 29 500 | 30 700 |
| Item 5, subparagraph (d) (vii) | 44 200 | 46 000 |
| Item 5A, paragraphs (a) to (f) | 3 820 | 3 970 |
| Item 5B | 12 700 | 13 200 |
| Item 6, paragraph (a) | 22 400 | 23 300 |
| Item 6, paragraphs (b), (c) and (ca) | 15 200 | 15 800 |
| Item 6, paragraph (d) | 25 500 | 26 500 |
| Item 6AA | 270 | 280 |
| Item 6AB | 480 | 500 |
| Item 6AC | 820 | 850 |
| Item 6AD, paragraph (a) | 15 200 | 15 800 |
| Item 6AD, paragraph (b) | 3 820 | 3 970 |
| Item 6A | 1 010 | 1 050 |
| Item 6B | 2 550 | 2 650 |
| Item 6C | 5 070 | 5 270 |
| Item 6D, paragraph (a) | 6 320 | 6 570 |
| Item 6D, paragraph (b) | 8 100 | 8 420 |
| Item 6D, paragraph (c) | 11 100 | 11 500 |
| Item 6D, paragraph (d) | 14 800 | 15 400 |
| Item 6D, paragraph (e) | 22 100 | 23 000 |
| Item 6D, paragraph (f) | 29 500 | 30 700 |
| Item 6D, paragraph (g) | 44 200 | 46 000 |
| Item 7, paragraph (a) | 7 620 | 7 920 |
| Item 7, paragraphs (b), (c) and (ca) | 6 350 | 6 600 |
| Item 7, paragraph (d) | 25 500 | 26 500 |
| Item 7, paragraphs (e) and (f) | 6 350 | 6 600 |
| Item 7A, paragraph (a) | 6 320 | 6 570 |
| Item 7A, subparagraph (b) (i) | 6 320 | 6 570 |
| Item 7A, subparagraph (b) (ii) | 8 100 | 8 420 |
| Item 7A, subparagraph (b) (iii) | 11 100 | 11 500 |
| Item 7A, subparagraph (b) (iv) | 14 800 | 15 400 |
| Item 7A, subparagraph (b) (v) | 22 100 | 23 000 |
| Item 7A, subparagraph (b) (vi) | 29 500 | 30 700 |
| Item 7A, subparagraph (b) (vii) | 44 200 | 46 000 |
| Item 7B, paragraph (a) | 6 320 | 6 570 |
| Item 7B, subparagraph (b) (i) | 6 320 | 6 570 |
| Item 7B, subparagraph (b) (ii) | 8 100 | 8 420 |
| Item 7B, subparagraph (b) (iii) | 11 100 | 11 500 |
| Item 7B, subparagraph (b) (iv) | 14 800 | 15 400 |
| Item 7B, subparagraph (b) (v) | 22 100 | 23 000 |
| Item 7B, subparagraph (b) (vi) | 29 500 | 30 700 |
| Item 7B, subparagraph (b) (vii) | 44 200 | 46 000 |
| Item 8 | 700 | 730 |
| Item 9, paragraph (a) | 460 | 480 |
| Item 9, paragraph (b) | 940 | 980 |
| Item 9AA | 460 | 480 |
| Item 9AB | 630 | 660 |
| Items 9AC and 9ACA | 460 | 480 |
| Item 9AD, paragraph (a) | 920 | 960 |
| Item 9AD, paragraph (b) | 7 880 | 8 200 |
| Item 9AD, paragraph (c) | 17 500 | 18 200 |
| Item 9AD, paragraph (d) | 23 600 | 24 500 |
| Item 9AD, paragraph (e) | 36 800 | 38 300 |
| Item 9AD, paragraph (f) | 48 900 | 50 900 |
| Item 9AD, paragraph (g) | 59 600 | 62 000 |
| Items 9B and 9C | 12 700 | 13 200 |
| Item 10 | 110 | 120 |
| Items 14 and 14A | 240 | 250 |
| Item 17, subparagraph (a) (i) | 160 | 170 |
| Item 17, subparagraph (a) (ii) | 200 | 210 |
| Item 17, subparagraph (a) (iii) | 330 | 340 |
| Item 17, paragraph (b) | $140 | $150 |
| Item 17A, subparagraph (a) (i) | 840 | 870 |
| Item 17A, subparagraph (a) (ii) | 430 | 450 |
| Item 17A, sub‑subparagraph (a) (iii) (A) | 630 | 660 |
| Item 17A, sub‑subparagraph (a) (iii) (B) | 170 | 180 |
| Item 17A, subparagraph (a) (iv) | 310 | 320 |
| Item 17A, subparagraph (a) (v) | 210 | 220 |
| Item 17A, sub‑subparagraph (a) (vi) (A) | 160 | 170 |
| Item 17A, sub‑subparagraph (a) (vi) (B) | 200 | 210 |
| Item 17A, sub‑subparagraph (a) (vi) (C) | 330 | 340 |
| Item 17A, paragraph (b) | $140 | $150 |
| Item 18 | 1 500 | 1 560 |
Note
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All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See
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