Poisons Standard Amendment No. 2 of 2010 (Cth)

POISONS STANDARD AMENDMENT No. 2 OF 2010

I, RUTH LOPERT, 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, amends the Poisons Standard 2010, in the manner set out in Schedule 1.

The amendments to the Poisons Standard 2010 as set out in Schedule 1 commence on

1 January 2011.

(signed by)

RUTH LOPERT

Delegate of the Secretary to the Department of Health and Ageing

Dated this 10^th day of December 2010

Schedule 1-Amendments to the Poisons Standard 2010

STANDARD

FOR THE

UNIFORM SCHEDULING

MEDICINES AND POISONS

No. 1

AMENDMENT No. 1

Effective Date – 1 January 2011

ISBN 978-1-74241-341-9

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the:

Commonwealth Copyright Administration

Attorney-General’s Department

Robert Garran Offices

National Circuit

BARTON ACT 2600

or at by the Australian Government under the Therapeutic Goods Act 1989.

Publication approval number: D0111

The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health and Ageing or the Secretary’s delegate. The basis of these amendments can be found in the ‘Delegate’s Reasons’, which can be accessed from the scheduling website:

inquiries should be directed to:

The Secretary

Medicines and Poisons Scheduling Secretariat

Office of Health Protection

Department of Health and Ageing

GPO Box 9848

CANBERRA ACT 2601

Or by email: [email protected]

Media Liaison Unit

Australian Government Department of Health and Ageing

TABLE OF CONTENTS

PART A – AMENDMENTS TO THE SUSMP NO. 1 1

PART 4 – THE SCHEDULES 1

SCHEDULE 4 – NEW ENTRIES 1

SCHEDULE 8 – NEW ENTRY 1

EDITORIAL AMENDMENTS AND ERRATA 2

PART 1 – INTERPRETATION – AMENDMENT 2

APPENDIX E – PART 2 – AMENDMENT 2

PART B – INFORMATION NOTE 3

PART A – AMENDMENTS TO THE SUSMP NO. 1

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

The delegate of 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. 1 (SUSMP1) and recommends that these amendments be adopted by the States and Territories with effect from 1 January 2011 unless otherwise stated.

PART 4 – THE SCHEDULES

SCHEDULE 4 – NEW ENTRIES

AFAMELANOTIDE (Melanocyte stimulating hormone).

ASENAPINE.

BELIMUMAB.

LINAGLIPTIN.

NITISINONE.

NOMEGESTROL.

ROFLUMILAST.

RUPATADINE.

SAPROPTERIN.

TAFLUPROST.

TUBERCULIN.

SCHEDULE 8 – NEW ENTRY

TAPENTADOL.

EDITORIAL AMENDMENTS AND ERRATA

PART 1 – INTERPRETATION – AMENDMENT

Appropriate authority – Amend entry to read:

“Appropriate authority” means:

(a) in the Australian Capital Territory, ACT Health;

(b) for the purpose of providing an exemption from all or part of sections 2 through 12 of this Standard by the Australian Pesticides and Veterinary Medicines Authority, the Chief Executive Officer or their delegate;

(c) in New South Wales, the Director-General of New South Wales Health;

(d) in the Northern Territory, the Chief Health Officer of the Department of Health & Families;

(e) in Queensland, the Chief Executive of Queensland Health;

(f) in South Australia, the Chief Executive of the Department of Health;

(g) in Tasmania, the Secretary of the Department of Health and Human Services;

(h) for the purpose of providing an exemption from all or part of sections 2 through 12 of this Standard by the Therapeutic Goods Administration, the National Manager or their delegate;

(i) in Victoria, the Secretary to the Department of Health;

(j) in Western Australia, the Chief Executive Officer of the Department of Health.

APPENDIX E – PART 2 – AMENDMENT

Trifluoromethane-sulphonic acid – Amend entry to read:

POISON STANDARD STATEMENTS

Trifluoromethanesulfonic acid A,G3,E2

PART B – INFORMATION NOTE

Amendments set out in subsection 3(2) of the Poisons Standard 2010 will commence 1 January 2011.