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Reasons for Delegates' Final Decisions, February 2012

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Reasons for Delegates' Final Decisions, February 2012 FINAL DECISIONS & REASONS FOR DECISIONS BY DELEGATES OF THE SECRETARY TO THE DEPARTMENT OF HEALTH AND AGEING FEBRUARY 2012 Delegates’ final decisions on scheduling matters: · Initially referred to the October 2011 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) [ACCS#3]; · Initially referred to the October 2011 meeting of the Advisory Committee on Medicines Scheduling (ACMS) [ACMS#4]; or · Considered as delegate-only matters, i.e. were not referred to an expert advisory committee. Notice under subsections 42ZXZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations) A delegate of the Secretary to the Department of Health and Ageing hereby gives notice of delegates’ final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons – SUSMP) under subsections 42ZCZS and 42ZCZX of the Regulations. This notice also provides the reasons for each decision and the date of effect of the decision. Edited versions of further submissions on interim decisions for matters referred to ACCS#3, or ACMS#4 are also available at www.tga.gov.au/industry/scheduling-submissions.htm. Matters referred to ACCS#3 and ACMS#4 Delegates’ interim decisions on recommendations by ACCS#3 and ACMS#4 were published on 21 December 2011, accessible at www.tga.gov.au/industry/scheduling-decisions- interim.htm. This public notice also invited further comment from the applicant and from those parties who made a valid submission in response to the original invitation for submissions (published 10 August 2011, accessible at www.tga.gov.au/regulation/scheduling- adv-com.htm). In accordance with subsection 42ZCZR of the Regulations, if a delegate makes an interim decision on an application, that delegate may make a final decision confirming, varying or setting aside the interim decision only after considering any further valid submissions. If no further submissions were received then the delegate may choose to confirm the interim decision as the final decision. Further submissions from parties other than those who made a valid submission in response to the original invitation or the applicant, or those received after the closing date, need not be considered by the delegate. Matters not referred to an advisory committee A delegate may decide not to refer a matter to an expert advisory committee and instead may make a final decision on matters. Guidance for the delegate when deciding not to refer a matter to an expert advisory committee is set out in the Scheduling Policy Framework (SPF) accessible at www.tga.gov.au/industry/scheduling-spf.htm. Implementation The amendments arising from this notice will be incorporated into the SUSMP through an amendment which will be available for purchase from National Mailing and Marketing Pty Ltd, telephone (02) 6269 1035. The SUSMP and its amendments are also available electronically at the ComLaw website, a link to which can be found at www.tga.gov.au/industry/scheduling-poisons-standard.htm. Delegates’ reasons for final decisions February 2012 i TABLE OF CONTENTS GLOSSARY ................................................................................................................................................................. II PART A – FINAL DECISIONS ON MATTERS REFERRED TO AN ADVISORY COMMITTEE ................. 1 1. MATTERS INITIALLY REFERRED TO ACCS#3 – OCTOBER 2011 ...................................................... 1 1.1 AMETOCTRADIN ............................................................................................................................................... 1 1.2 DELTAMETHRIN ................................................................................................................................................ 8 1.3 FLUXAPYROXAD ............................................................................................................................................. 19 1.4 INDAZIFLAM ................................................................................................................................................... 27 1.5 PROSULFURON ................................................................................................................................................ 34 1.6 DICAMBA........................................................................................................................................................ 42 2. MATTERS INITIALLY REFERRED TO ACMS#4 – OCTOBER 2011 ................................................... 51 2.1 AZELASTINE ................................................................................................................................................... 51 2.2 DICLOFENAC .................................................................................................................................................. 62 2.3 FAMCICLOVIR ................................................................................................................................................. 82 2.4 FOLLISTATIN ................................................................................................................................................ 106 2.5 3, 4-METHYLENEDIOXYPYROVALERONE (MDPV) ....................................................................................... 109 2.6 PIPER METHYSTICUM (KAVA) ....................................................................................................................... 115 2.7 SYNTHETIC CANNABINOIDS .......................................................................................................................... 126 PART B – FINAL DECISIONS ON MATTERS NOT REFERRED TO AN ADVISORY COMMITTEE .... 148 3. CHEMICALS ................................................................................................................................................. 148 3.1 PENTHIOPYRAD ............................................................................................................................................ 148 4. MEDICINES ................................................................................................................................................... 152 4.1 ENTHEOGENS ................................................................................................................................................ 152 4.2 AFLIBERCEPT................................................................................................................................................ 159 4.3 BELATACEPT ................................................................................................................................................ 160 4.4 CEFTAROLINE FOSAMIL ................................................................................................................................ 161 4.5 DAPAGLIFLOZIN ........................................................................................................................................... 162 4.6 ERIBULIN MESYLATE .................................................................................................................................... 163 4.7 INGENOL MEBUTATE ..................................................................................................................................... 164 4.8 LIXISENATIDE ............................................................................................................................................... 165 4.9 PITAVASTATIN .............................................................................................................................................. 166 4.10 RECOMBINANT NEISSERIA MENINGITIDIS ................................................................................................ 167 4.11 RIFAXIMIN ............................................................................................................................................... 168 4.12 TALIGLUCERASE ALFA ............................................................................................................................ 169 4.13 VELAGLUCERASE ALFA ........................................................................................................................... 170 4.14 VEMURAFENIB ......................................................................................................................................... 171 5. EDITORIALS AND ERRATA ...................................................................................................................... 172 5.1 “OROMUCOSAL” DEFINITION ........................................................................................................................ 172 5.2 DIMETHYL SULFOXIDE.................................................................................................................................. 172 5.3 EMODEPSIDE ................................................................................................................................................ 173 5.4 SODIUM LAURYL SULFATE ............................................................................................................................ 173 5.5 LAURETH CARBOXYLIC ACIDS ...................................................................................................................... 174 Delegates’ reasons for final decisions February 2012 ii GLOSSARY ABBREVIATION NAME AAN Australian Approved Name AC Active constituent ACCC Australian Competition and Consumer Commission
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