Source: https://www.legislation.gov.au/Details/F2015L01909
Timestamp: 2019-10-15 13:39:31
Document Index: 699537465

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'arts 2', 'art 2']

Therapeutic Goods Amendment (Listed Medicines) Regulation 2015
Details: F2015L01909
- F2015L01909
SLI 2015 No. 213 Regulations as made
This regulation amends the Therapeutic Goods Regulations 1990 to specify the ingredients that can be used in medicines listed on the Australian Register of Therapeutic Goods under section 26A of the Act and requirements in relation to those ingredients being contained in such medicines.
F2015L01909
Select Legislative Instrument No. 213, 2015
This is the Therapeutic Goods Amendment (Listed Medicines) Regulation 2015.
1 At the end of regulation 3AA
; 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)
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)
6 Part 1 of Schedule 4 (table item 3)
(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)
8 Part 1 of Schedule 4 (table item 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)
(a) each dilution is more dilute than a 1,000 fold dilution of mother tincture; 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)
11 Part 1 of Schedule 4 (table item 7, paragraph (c))
(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)
13 Parts 2, 3, 4 and 5 of Schedule 4
14 Part 2 of Schedule 9 (after table item 7B)
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:
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: