Therapeutic Goods Amendment (Listed Medicines) Regulation 2015 (Cth)
Therapeutic Goods Amendment (Listed Medicines) Regulation 2015
Select Legislative Instrument No. 213, 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 26 November 2015
Peter Cosgrove
Governor‑General
By His Excellency’s Command
Fiona Nash
Minister for Rural Health
Contents
1............ Name.................................................................................................. 1
2............ Commencement.................................................................................. 1
3............ Authority............................................................................................ 1
4............ Schedules............................................................................................ 1
Schedule 1—Amendments 2
Therapeutic Goods Regulations 1990 2
1Name
This is the Therapeutic Goods Amendment (Listed Medicines) 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 January 2016. | 1 January 2016 |
Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 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:
| 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:
| 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:
| 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:
|
(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:
| 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): |
|
(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 |
| (i) not over 50 pages | 9 870 |
| (ii) over 50 pages, but not over 250 pages | 12 700 |
| (iii) over 250 pages, but not over 500 pages | 17 400 |
| (iv) over 500 pages, but not over 1 000 pages | 23 000 |
| (v) over 1 000 pages, but not over 2 000 pages | 34 500 |
| (vi) over 2 000 pages, but not over 3 000 pages | 46 100 |
| (vii) over 3 000 pages | 69 000 |
| 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: |
|
(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 |
| (i) not over 50 pages | 9 870 |
| (ii) over 50 pages, but not over 250 pages | 12 700 |
| (iii) over 250 pages, but not over 500 pages | 17 400 |
| (iv) over 500 pages, but not over 1 000 pages | 23 000 |
| (v) over 1 000 pages, but not over 2 000 pages | 34 500 |
| (vi) over 2 000 pages, but not over 3 000 pages | 46 100 |
| (vii) over 3 000 pages | 69 000 |
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