Therapeutic Goods Amendment Regulations 2005 (No. 1) (Cth)
Therapeutic Goods Amendment Regulations 2005 (No. 1)1
Select Legislative Instrument 2005 No. 192
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 18 August 2005
P. M. JEFFERY
Governor-General
By His Excellency’s Command
CHRISTOPHER PYNE
Parliamentary Secretary to the Minister for Health and Ageing
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Name of Regulations
These Regulations are the Therapeutic Goods Amendment Regulations 2005 (No. 1).
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Commencement
These Regulations commence on the day after they are registered.
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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 3A
omit
For paragraph 3 (5) (e)
insert
(1)For paragraph 3 (5) (e)
[2] Regulation 3A
insert
(2)For paragraph 3 (5) (e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recovery.
[3] Regulation 6A
substitute
6AApproval of use of restricted representation — public interest criteria
For paragraph 42DF (4) (c) of the Act, Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is prescribed.
[4] Regulation 45 — amendment of fees
| Provision | omit | insert |
| Paragraph 45 (4A) (a) | $7 240; | $7 360; |
| Paragraphs 45 (4A) (b), (c) and (ca) | $6 040; | $6 140; |
| Paragraph 45 (4A) (d) | $24 200; | $24 600; |
| Paragraph 45 (4A) (e) | $6 040; | $6 140; |
| Paragraph 45 (4A) (f) | $6 040. | $6 140. |
| Paragraphs 45 (9) (a), (b), (c), (ca) and (d) | $3 630; | $3 690; |
| Paragraph 45 (9) (e) | $3 630. | $3 690. |
| Paragraphs 45 (11) (a), (b), (c), (ca) and (d) | $1 330; | $1 350; |
| Paragraph 45 (11) (e) | $1 330. | $1 350. |
[5] Regulation 45A, heading
substitute
45ACharges reduced if annual turnover is not more than $66 000
[6] Subregulation 45A (1)
omit
$65 000
insert
$66 000
[7] Schedule 9, Part 1, subclause 1 (1), after definition of broadcast media
insert
haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells.
[8] Schedule 9, Part 2, item 9, paragraph (a), column 2
omit
(except for therapeutic goods mentioned in items 9AB, 9AC and 9ACA),
insert
(except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA),
[9] Schedule 9, Part 2, after item 9
insert
| 9AA | fee for inspection (including an inspection for paragraph 58 (3) (b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour | 440 |
[10] Schedule 9, Part 2, items 9AB and 9AC, column 2
omit
human blood and blood components
insert
human blood and blood components (other than haematopoietic progenitor cells)
[11] Schedule 9, Part 2, column 3 — amendment of fees
| Provision | omit | insert |
| Item 1A | 300 | 310 |
| Item 1, paragraph (c) | 12 100 | 12 300 |
| Item 1, paragraph (d) | 1 820 | 1 850 |
| Item 2, paragraph (a) | 780 | 790 |
| Item 2, paragraph (b) | 960 | 980 |
| Item 2, paragraph (ba) | 5 850; | 5 950; |
| Item 2, paragraph (c) | 2 900 | 2 950 |
| Item 2, paragraph (d) | 1 450 | 1 470 |
| Item 2, paragraph (d) | $8 440 | $8 580 |
| Item 2, paragraph (f) | 340 | 350 |
| Item 2, paragraph (g) | 960 | 980 |
| Item 2, paragraph (h) | 490 | 500 |
| Item 2AA | 670 | 680 |
| Item 2A, paragraph (b) | 780 | 790 |
| Item 2A, paragraph (c) | 240 | 250 |
| Item 2A, paragraph (d) | 490 | 500 |
| Item 2A, paragraph (e) | 960 | 980 |
| Item 2A, paragraphs (f) and (g) | 300 | 310 |
| Items 2B and 2C | 4 280 | 4 170 |
| Item 3, paragraph (a) | 300 | 310 |
| Item 3, paragraph (b) | 490 | 500 |
| Item 3AA | 340 | 350 |
| Item 4, paragraph (a) | 189 900 | 182 900 |
| Item 4, paragraph (b) | 112 900 | 108 800 |
| Item 4, paragraph (c) | 67 000 | 65 000 |
| Item 4, paragraph (d) | 11 900 | 11 500 |
| Item 4, paragraph (e) | 4 280 | 4 170 |
| Item 4, paragraph (g) | 73 600 | 70 900 |
| Item 4, paragraph (h) | 4 280 | 4 170 |
| Item 5, paragraph (a) and subparagraph (b) (i) | 5 190 | 5 270 |
| Item 5, subparagraph (b) (ii) | 6 640 | 6 750 |
| Item 5, subparagraph (b) (iii) | 9 060 | 9 200 |
| Item 5, subparagraph (b) (iv) | 12 060 | 12 300 |
| Item 5, subparagraph (b) (v) | 18 100 | 18 400 |
| Item 5, subparagraph (b) (vi) | 24 200 | 24 600 |
| Item 5, subparagraph (b) (vii) | 36 200 | 36 800 |
| Item 5, paragraph (c) and subparagraph (d) (i) | 1 870 | 1 900 |
| Item 5, subparagraph (d) (ii) | 6 640 | 6 750 |
| Item 5, subparagraph (d) (iii) | 9 060 | 9 200 |
| Item 5, subparagraph (d) (iv) | 12 100 | 12 300 |
| Item 5, subparagraph (d) (v) | 18 100 | 18 400 |
| Item 5, subparagraph (d) (vi) | 24 200 | 24 600 |
| Item 5, subparagraph (d) (vii) | 36 200 | 36 800 |
| Item 5A, paragraphs (a) to (f) | 3 630 | 3 690 |
| Item 5B | 12 100 | 12 300 |
| Item 6, paragraph (a) | 21 300 | 21 600 |
| Item 6, paragraphs (b), (c) and (ca) | 14 500 | 14 700 |
| Item 6, paragraph (d) | 24 200 | 24 600 |
| Item 6AA | 250 | 260 |
| Item 6AB | 220 | 230 |
| Item 6AC | 780 | 790 |
| Item 6AD, paragraph (a) | 14 500 | 14 700 |
| Item 6AD, paragraph (b) | 3 630 | 3 690 |
| Item 6A | 960 | 980 |
| Item 6B | 2 420 | 2 460 |
| Item 6C | 4 830 | 4 900 |
| Item 6D, paragraph (a) | 5 190 | 5 270 |
| Item 6D, paragraph (b) | 6 640 | 6 750 |
| Item 6D, paragraph (c) | 9 060 | 9 200 |
| Item 6D, paragraph (d) | 12 100 | 12 300 |
| Item 6D, paragraph (e) | 18 100 | 18 400 |
| Item 6D, paragraph (f) | 24 200 | 24 600 |
| Item 6D, paragraph (g) | 36 200 | 36 800 |
| Item 7, paragraph (a) | 7 240 | 7 360 |
| Item 7, paragraphs (b), (c) and (ca) | 6 040 | 6 140 |
| Item 7, paragraph (d) | 24 200 | 24 600 |
| Item 7, paragraphs (e) and (f) | 6 040 | 6 140 |
| Item 7A, paragraph (a) and subparagraph (b) (i) | 5 190 | 5 270 |
| Item 7A, subparagraph (b) (ii) | 6 640 | 6 750 |
| Item 7A, subparagraph (b) (iii) | 9 060 | 9 200 |
| Item 7A, subparagraph (b) (iv) | 12 100 | 12 300 |
| Item 7A, subparagraph (b) (v) | 18 100 | 18 400 |
| Item 7A, subparagraph (b) (vi) | 24 200 | 24 600 |
| Item 7A, subparagraph (b) (vii) | 36 200 | 36 800 |
| Item 7B, paragraph (a) and subparagraph (b) (i) | 5 190 | 5 270 |
| Item 7B, subparagraph (b) (ii) | 6 640 | 6 750 |
| Item 7B, subparagraph (b) (iii) | 9 060 | 9 200 |
| Item 7B, subparagraph (b) (iv) | 12 100 | 12 300 |
| Item 7B, subparagraph (b) (v) | 18 100 | 18 400 |
| Item 7B, subparagraph (b) (vi) | 24 200 | 24 600 |
| Item 7B, subparagraph (b) (vii) | 36 200 | 36 800 |
| Item 8 | 670 | 680 |
| Item 9, paragraph (a) | 430 | 440 |
| Item 9, paragraph (b) | 900 | 910 |
| Item 9AB | 600 | 610 |
| Items 9AC and 9ACA | 430 | 440 |
| Item 9AD, paragraph (a) | 880 | 890 |
| Item 9AD, paragraph (b) | 7 490 | 7 610 |
| Item 9AD, paragraph (c) | 16 600 | 16 900 |
| Item 9AD, paragraph (d) | 22 400 | 22 800 |
| Item 9AD, paragraph (e) | 35 000 | 35 600 |
| Item 9AD, paragraph (f) | 46 500 | 47 200 |
| Item 9AD, paragraph (g) | 56 700 | 57 600 |
| Items 9B and 9C | 12 100 | 12 300 |
| Item 10 | 90 | 100 |
| Item 17, subparagraph (a) (i) | 140 | 150 |
| Item 17, subparagraph (a) (ii) | 180 | 190 |
| Item 17, subparagraph (a) (iii) | 310 | 320 |
| Item 17, subparagraph (a) (iv) | 70 | 80 |
| Item 17, paragraph (b) | $120 | $130 |
| Item 17, paragraph (c) | 70 | 80 |
| Item 17A, subparagraph (a) (i) | 800 | 810 |
| Item 17A, subparagraph (a) (ii) | 400 | 410 |
| Item 17A, sub-subparagraph (a) (iii) (A) | 600 | 610 |
| Item 17A, sub-subparagraph (a) (iii) (B) | 150 | 160 |
| Item 17A, subparagraph (a) (iv) | 290 | 300 |
| Item 17A, subparagraph (a) (v) | 190 | 200 |
| Item 17A, sub-subparagraph (a) (vi) (A) | 140 | 150 |
| Item 17A, sub-subparagraph (a) (vi) (B) | 180 | 190 |
| Item 17A, sub-subparagraph (a) (vi) (C) | 310 | 320 |
| Item 17A, paragraph (b) | $120 | $130 |
| Item 18 | 10 300 | 10 500 |
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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