Federal Register of Legislation - Australian Government

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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.
Administered by: Health
Registered 01 Dec 2015
Tabling HistoryDate
Tabled HR02-Dec-2015
Tabled Senate03-Dec-2015
Date of repeal 02 Jan 2016
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003
Table of contents.

 

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

 


1  Name

                   This is the Therapeutic Goods Amendment (Listed Medicines) Regulation 2015.

2  Commencement

             (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Note:          This table relates only to the provisions of this instrument as originally made.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.

3  Authority

                   This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

                   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 1Amendments

  

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