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Poisons Standard Amendment No. 5 of 2012

Authoritative Version
  • - F2012L02515
  • No longer in force
No. 5 of 2012 Standards/Other as made
This instrument amends the Poisons Standard 2012.
Administered by: Health
Registered 18 Dec 2012
Tabling HistoryDate
Tabled HR05-Feb-2013
Tabled Senate05-Feb-2013
Date of repeal 02 Jan 2013
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

 

 

 

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POISONS STANDARD AMENDMENT No. 5 OF 2012

 

I, ANTHONY GILL, a delegate of the Secretary to the Department of Health and Ageing for the purposes of paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, hereby amend the Poisons Standard 2012 in the manner set out in Schedule 1.

 

The amendments to the Poisons Standard 2012 as set out in Schedule 1 commence on 1 January 2013.

 

 

(Signed by)

 

ANTHONY GILL

Delegate of the Secretary to the Department of Health and Ageing

 

 

Dated this 13th day of December 2012

 


 

Schedule 1-Amendments to the Poisons Standard 2012

 

 

 

STANDARD

FOR THE

UNIFORM SCHEDULING

OF

MEDICINES AND POISONS

 

No. 3

 

 

 

AMENDMENT No. 4

 

Effective Date – 1 January 2013


ISBN: 978-1-74241-846-9

 

© Commonwealth of Australia 2012

 

This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Online, Services and External Relations Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.

 

Published by the Australian Government.

 

Publications approval number: D1014

 

 

 

 

 

 

 

The amendments listed in this document are a result of decisions made by a delegate of the Department of Health and Ageing in September, October and November 2012.  The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at www.tga.gov.au/industry/scheduling-decisions.htm.

 

Further inquiries should be directed to:

 

The Secretary

Medicines and Poisons Scheduling Secretariat (MDP88)

Office of Health Protection

Department of Health and Ageing

GPO Box 9848

CANBERRA  ACT  2601

 

or by email:  SMP@health.gov.au

 

Media Liaison Unit

Australian Government Department of Health and Ageing


 


Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons

The Secretary of the Department of Health and Ageing directs that the amendments below be applied to the Standard for the Uniform Scheduling of Medicines and Poisons No. 3 (SUSMP 3) and recommends that these amendments be adopted by the states and territories with effect from 1 January 2013. 

 

PART 4 – THE SCHEDULES

SCHEDULE 2 – AMENDMENTS

 

CETIRIZINE – Amend entry to read:

 

CETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

 

(a)                in a primary pack containing not more than 5 days’ supply; and

 

(b)        labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

 

IBUPROFEN – Amend entry to read:

 

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

 

(a)                in liquid preparations when sold in the manufacturer’s original pack containing 8 grams or less of ibuprofen; or

 

(b)               in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:

 

(i)                 as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);

 

(ii)               packed in blister or strip packaging or in a container with a child-resistant closure;

 

(iii)             in a primary pack containing not more than 25 dosage units;

 

(iv)             compliant with the requirements of the Required Advisory Statements for Medicine Labels;

 

(v)               not labelled for the treatment of children 6 years of age or less; and

 

(vi)             not labelled for the treatment of children under 12 years of age when combined with phenylephrine.

 

SCHEDULE 4 – NEW ENTRIES

 

ABIRATERONE ACETATE.

 

BOCEPREVIR.

 

FIDAXOMICIN.

 

RIDAFOROLIMUS.

 

TELAPREVIR.

 

SCHEDULE 4 – AMENDMENTS

 

CETIRIZINE – Amend entry to read:

 

CETIRIZINE except

 

(a)                when included in Schedule 2; or

 

(b)        in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

 

(i)                 in a primary pack containing not more than 5 days’ supply; and


(ii)        labelled with a recommended daily dose not exceeding 10 mg         of cetirizine.

 

TRANEXAMIC ACID – Amend entry to read:

 

TRANEXAMIC ACID except in preparations containing 3 per cent or less of cetyl tranexamate hydrochloride for dermal cosmetic use. 

 

SCHEDULE 5 – NEW ENTRIES

 

PENFLUFEN.

 

AMINOCYCLOPYRACHLOR.


 

PART 5 – THE APPENDICES

 

APPENDIX L – NEW ENTRY

 

Column 1                                           Column 2

Substance                                           Warning Statement

 

Fingolimod.                                         76

 

EDITORIAL AMENDMENTS AND ERRATA

 

PART 4 – THE SCHEDULES

 

SCHEDULE 2 - AMENDMENT

 

CICLOPIROX – Amend entry to read:

 

CICLOPIROX:

 

(a)                in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis; or

 

(b)               in preparations for application to the nails containing 8 per cent or less of ciclopirox.