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

Scheduling medicines and poisons

4 August 2016

This consultation closed on 1 September 2016

Invitation to comment

The TGA sought 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).

1. 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.

Timetable

Document released for consultation on 4 August 2016.

Interested parties should respond by close of business 1 September 2016.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK/42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations).

The delegate of the Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the above scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Content of submissions

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.

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA Internet website: feedback on submissions will be provided through the TGA Internet site: Public submissions on scheduling matters

Scheduling decisions made by the medicines delegate following consideration of submissions from interested parties, along with advice from the Advisory Committee on Medicines Scheduling (ACMS) will be published on the TGA website as interim decisions.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to .