Commonwealth Numbered Regulations Commonwealth Numbered Regulations
Therapeutic Goods Regulations 1990
1 At the end of regulation 3AA
Add:
; or (c) a medicine that satisfies the following requirements:
(i) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act;
(ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine--none of the requirements have been contravened.
2 Paragraph 10(b)
Omit "Part 1 of".
3 Part 1 of Schedule 3 (table item 1, paragraph (a))
Omit "in Part 1".
4 Part 1 of Schedule 3 (table item 2, paragraph (a))
Omit "items 3 to 10 (inclusive) in Part 1", substitute "item 3, 4A, 5 or 7".
5 Part 1 of Schedule 4 (heading)
Repeal the heading.
6 Part 1 of Schedule 4 (table item 3)
Repeal the item, substitute:
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3 |
medicines where: (a) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and (b) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine--none of the requirements have been contravened; and (c) the ingredients in the medicine: (i) are not included in a Schedule to the Poisons Standard or Appendix C of the Poisons Standard; and (ii) are not of a kind required to be sterile; and (d) the indications proposed by the sponsor of the medicine are not for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code |
7 Part 1 of Schedule 4 (table item 4)
Repeal the item.
8 Part 1 of Schedule 4 (table item 4A)
Repeal the item, substitute:
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4A |
homeopathic preparations where: (a) the preparation consists of, or contains a dilution of, mother tincture that is a 1,000 fold dilution, or a lesser dilution, of that mother tincture; and (b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and (c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation--none of the requirements have been contravened; and (d) the preparation is not required to be sterile; and (e) none of the ingredients in the preparation are included in a Schedule to the Poisons Standard or Appendix C of the Poisons Standard (other than any ingredient that is more than a 1,000-fold dilution of mother tincture) |
9 Part 1 of Schedule 4 (table item 5)
Repeal the item, substitute:
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5 |
homeopathic preparations where: (a) each dilution is more dilute than a 1,000 fold dilution of mother tincture; and (b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and (c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation--none of the requirements have been contravened; and (d) the preparation is not required to be sterile; and (e) according to the indications proposed by the sponsor of the preparation, the preparation is for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code |
10 Part 1 of Schedule 4 (table item 6)
Repeal the item.
11 Part 1 of Schedule 4 (table item 7, paragraph (c))
Repeal the paragraph, substitute:
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(c) the sunscreen preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and (d) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the sunscreen preparation--none of the requirements have been contravened |
12 Part 1 of Schedule 4 (table items 8, 9, 10 and 10A)
Repeal the items.
13 Parts 2, 3, 4 and 5 of Schedule 4
Repeal the Parts.
14 Part 2 of Schedule 9 (after table item 7B)
Insert:
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7C |
Evaluation fee in relation to an application for a variation of a determination under subsection 26BD(1) (other than an application to which item 7D of this table applies): |
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(a) if the application does not contain clinical or toxicological information (b) if the application contains clinical or toxicological information, and the total number of pages is: |
9 870 |
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(i) not over 50 pages |
9 870 |
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(ii) over 50 pages, but not over 250 pages |
12 700 |
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(iii) over 250 pages, but not over 500 pages |
17 400 |
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(iv) over 500 pages, but not over 1 000 pages |
23 000 |
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(v) over 1 000 pages, but not over 2 000 pages |
34 500 |
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(vi) over 2 000 pages, but not over 3 000 pages |
46 100 |
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(vii) over 3 000 pages |
69 000 |
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7D |
Evaluation fee in relation to an application for a variation of a determination under subsection 26BD(1) in relation to 1 or more new excipients for use in particular therapeutic goods: |
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(a) if the application does not contain clinical or toxicological information (b) if the application contains clinical or toxicological information, and the total number of pages is: |
9 870 |
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(i) not over 50 pages |
9 870 |
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(ii) over 50 pages, but not over 250 pages |
12 700 |
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(iii) over 250 pages, but not over 500 pages |
17 400 |
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(iv) over 500 pages, but not over 1 000 pages |
23 000 |
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(v) over 1 000 pages, but not over 2 000 pages |
34 500 |
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(vi) over 2 000 pages, but not over 3 000 pages |
46 100 |
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(vii) over 3 000 pages |
69 000 |