Final decisions & reasons for decisions by delegates of the Secretary to the Department of Health 29 June 2017 (ACMS and ACCS meetings – March 2017) Notice under subsections 42ZCZS/42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations) The delegates of the Secretary to the Department of Health hereby give 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/42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). This notice also provides the reasons for each decision and the date of effect (implementation date) of the decision. The delegates’ final decisions and reasons relate to: · scheduling proposals initially referred to the March 2017 meeting of the Advisory Committee on Medicines Scheduling (ACMS#20); · scheduling proposals initially referred to the March 2017 Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS#15); · scheduling proposals initially referred to the March 2017 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#19); and · scheduling proposals considered as delegate-only matters, i.e. not referred to an expert advisory committee. Scheduling proposals referred to the expert advisory committees. Pre-meeting public notices On 22 December 2016 and 3 February 2017, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published pre-meeting public notices on the TGA website which specified the proposed amendments to the current Poisons Standard. The notices also invited public comment on the scheduling proposals referred to the expert advisory committees. The pre-meeting consultation periods were open for public comment for 20 business days and closed on 10 February 2017 and 3 March 2017, respectively. Page 1 of 149 In accordance with subsection 42ZCZL of the Regulations, redacted versions of public submissions received in response to these invitations for public comment will be published on or after the date of this notice on the TGA website at Public submissions on scheduling matters. Interim decisions On 17 May 2017, in accordance with subsection 42ZCZN of the Regulations, the delegate made an interim decision on an application and under subsection 42ZCZP of the Regulations, the interim decision and the reasons for the decision was published on TGA website. Further submissions were also invited from the applicants and parties who made valid pre-meeting submissions. The inivitation to make submissions was open for 10 business days and closed on 31 May 2017. Redacted versions of public submissions will be published at Public submissions on scheduling matters on or after the date of this notice. Final decisions In accordance with subsection 42ZCZR of the Regulations, if a delegate makes an interim decision on an application, the delegate may make a final decision either confirming, varying or setting aside the interim decision, but only after considering any valid submissions received in response to the interim decisions. Matters not referred to an advisory committee According to subsections 42ZCZT/42ZCZU of the Regulations a delegate may decide not to refer a scheduling proposal to an expert advisory committee for advice and instead may make a delegate-only decision. When deciding not to refer a matter to a committee, the delegate considers the scheduling guidelines as set out in the Scheduling Policy Framework for Chemicals and Medicines (SPF, 2015), available at SPF, February 2015. Publishing of the amendments to the Poisons Standard The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on the Federal Register of Legislation (FRL) as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on FRL, is available at SUSMP. Delegates’ final decisions and reasons for NCES and substances sent to the Page 2 of 149 March 2017 scheduling meetings - June 2017 Table of contents Part A - Final decisions on matters referred to an expert advisory committee (March 2017) ______________________________________________ 5 1. Advisory Committee on Medicines Scheduling (ACMS #20) _____ 5 1.1. Dihydrocodeine ____________________________________________________________________________ 8 1.2. 1,3-Dimethylbutylamine (DMBA) and other aliphatic alkylamines including 1,5- dimethylhexylamine (DMHA) __________________________________________________________________ 15 1.3. Ulipristal _________________________________________________________________________________ 23 1.4. Ibuprofen _________________________________________________________________________________ 29 1.5. Flurbiprofen _____________________________________________________________________________ 39 1.6. Penciclovir _______________________________________________________________________________ 43 1.7. Loratadine _______________________________________________________________________________ 50 2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #15) ________________________________ 60 2.1. N-(alkylamino) cyclohexylbenzamides (opioids) _____________________________________ 61 2.2. In Vitro Diagnostic and Analytical Preparations ______________________________________ 68 2.3. Sodium a-olefin sulfonates _____________________________________________________________ 74 3. Advisory Committee on Chemicals Scheduling (ACCS #19) ____ 81 3.1. Ethyl hexanediol _________________________________________________________________________ 85 3.2. Climbazole _______________________________________________________________________________ 93 3.3. m-Aminophenol ________________________________________________________________________ 101 3.4. 2-Chloro-6-(ethylamino)-4-nitrophenol ______________________________________________ 110 3.5. 2,4-Diaminophenoxyethanol __________________________________________________________ 118 3.6. Isoeugenol ______________________________________________________________________________ 126 3.7. Aureobasidium pullulans (strains DSM 14940 and DSM 14941) ____________________ 134 Part B - Final decisions on matters not referred to an expert advisory committee ______________________________________________ 140 4. New Chemical Entities – medicines for human therapeutic use 140 4.1. Migalastat _______________________________________________________________________________ 140 4.2. Fosfomycin ______________________________________________________________________________ 142 4.3. Dupilumab ______________________________________________________________________________ 143 4.4. Influenza virus haemagglutinin _______________________________________________________ 145 4.5. Bezlotoxumab ___________________________________________________________________________ 147 4.6. Rurioctocog alfa pegol _________________________________________________________________ 148 Delegates’ final decisions and reasons for NCES and substances sent to the Page 3 of 149 March 2017 scheduling meetings - June 2017 Delegates’ final decisions and reasons for NCES and substances sent to the Page 4 of 149 March 2017 scheduling meetings - June 2017 Part A - Final decisions on matters referred to an expert advisory committee (March 2017) 1. Advisory Committee on Medicines Scheduling (ACMS #20) Summary of final interim decisions The implementation date for the following decisions is 1 October 2017 unless otherwise indicated. Substance Final decision Dihydrocodeine Schedule 8 – Amend Entry DIHYDROCODEINE except when included in Schedule 3 or 4. Schedule 4 – Amend Entry DIHYDROCODEINE when compounded with one or more other therapeutically active substances: a) in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or b) in undivided preparations with a concentration of not more than 2.5 per cent of dihydrocodeine, except when included in Schedule 3. Schedule 3 – Amend Entry DIHYDROCODEINE when indicated for cough suppression and compounded with one or more other therapeutically active substances: a) in divided preparations containing 10 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or b) in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine. Schedule 2 – Delete Entry 1,3-Dimethylbutylamine Schedule 10 – New Entries (DMBA) and other aliphatic 1,3-DIMETHYLBUTYLAMINE (DMBA) except when separately alkylamines including 1,5- specified in these schedules. dimethylhexylamine (DMHA) 1,5-DIMETHYLHEXYLAMINE (DMHA) except when separately specified in these schedules. ALKYLAMINES WITH STIMULANT PROPERTIES except when separately specified in these schedules. Index – New Entries Delegates’ final decisions and reasons for NCES and substances sent to the Page 5 of 149 March 2017 scheduling meetings - June 2017 Substance Final decision 1,3-DIMETHYLBUTYLAMINE (DMBA) cross reference: octodrine, 1-aminoisoheptane, DMHA, 1,5- dimethylhexylamine, 4-methylhexane-2-amine, 1,3- dimethylamylamine, DMAA, 4-amino-2-methylpentane Citrate (AMP Citrate) Schedule 10 1,5-DIMETHYLHEXYLAMINE (DMHA) cross reference: 1,3-dimethylbutylamine, DMBA, octodrine, 1- aminoisoheptane, DMHA, 4-methylhexane-2-amine, 1,3- dimethylamylamine, DMAA, 4-amino-2-methylpentane