Consultation: Proposed amendments to the Poisons Standard – ACMS meeting, November 2016

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Medicines Scheduling (ACMS). Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS). Substance Proposal Melatonin An applicant has proposed that melatonin be exempt from scheduling (Schedule 4) in preparations containing 1 mg or less of melatonin. Fennel oil The TGA has proposed that a new Schedule 5 entry be created for fennel oil (active component of fennel oil – methyl chavicol), with consideration of the appropriateness of low volume containers with a restricted flow insert, Medicines Advisory Statements, such as ‘keep out of reach of children’; or exemption cut-off of 5 per cent or less of methyl chavicol. Paracetamol compounded with caffeine An applicant has proposed that combination products containing paracetamol and caffeine should be exempt from Schedule 2 when supplied in primary packs of not more than, 10 tablets/capsules or, 5 sachets of powders or granules. Vardenafil An applicant has proposed that a new Schedule 3 entry for vardenafil in oral preparations containing 10 mg or less of vardenafil per dosage unit in packs containing not more than 8 dosage units be created. Nicotine An applicant has proposed to exempt nicotine from Schedule 7 at concentrations of 3.6 per cent or less of nicotine for self-administration with an electronic nicotine delivery system (‘personal vaporiser’ or ‘electronic cigarette’) for the purpose of tobacco harm reduction. Vitamin D An applicant has proposed that vitamin D should be included in Appendix H. Cetirizine An applicant has proposed that cetirizine be exempt from Schedule 2 when in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over, when in a maximum pack size of 10 days’ supply labelled with a recommended daily dose not exceeding 10 mg of cetirizine. Panobinostat The delegate proposes a new Appendix L entry, with warning statement 62 – Do not use if pregnant, for panobinostat. Ceritinib The delegate proposes a new Appendix L entry, with warning statement 62 – Do not use if pregnant, for ceritinib. Olaparib The delegate proposes a new Appendix L entry, with warning statement 62 – Do not use if pregnant, for olaparib. Brivaracetam The delegate proposes a new Appendix K entry, for brivaracetam. Follitropin delta The delegate proposes to include follitropin delta in Appendix D, Item 1 – Poisons available only from or on the prescription or order of an authorised medical practitioner. Interested parties should submit comments by close of business 1 September 2016. Submissions may address any, or all, of the proposed amendments to the Poisons Standard (Medicines) or other identified issues. In addition, submissions might include: Suggested improvements; Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you. An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

TGA, 4 August 2016 ;http://www.tga.gov.au/ ;