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THERAPEUTIC GOODS AMENDMENT (LISTED MEDICINES) REGULATION 2015 (SLI NO 213 OF 2015) - 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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