Consultation: Proposed Amendments to the Poisons Standard - ACCS and ACMS meetings, November 2016

Scheduling medicines and poisons

22 September 2016

This consultation closed on 20 October 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 Chemicals Scheduling (ACCS) and 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 Chemicals Scheduling (ACCS).
Substance Proposal
4-[(2-Hydroxyethyl)amino]-3-nitrophenol NICNAS submitted an application to create a new Schedule 6 entry for 4-[(2-hydroxyethyl)amino]-3-nitrophenol in hair dyes and eyebrow/eyelash colouring products and to determine whether an appropriate exemption cut-off is required.
Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride salt NICNAS submitted an application to create a new Schedule 6 entry for hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride salt in hair dyes and eyebrow/eyelash colouring products and to determine whether appropriate exemption cut-off required.
2,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol and its monohydrochloride NICNAS submitted an application to create a new Schedule 6 entry for 2,2'-[(4-amino-3-nitrophenyl)imino]bisethanol and its monohydrochloride in hair dyes and eyebrow/eyelash colouring products and to determine whether an appropriate exemption cut-off is required.
2-[(4-Amino-2-methyl-5-nitrophenyl)amino]-ethanol NICNAS submitted an application to create a new Schedule 6 entry for 2-[(4-amino-2-methyl-5-nitrophenyl)amino]-ethanol in hair dyes and eyebrow/eyelash colouring products and to determine whether an appropriate exemption cut-off is required.
1,3-Bis(2,4-diaminophenoxy)propane tetrahydrochloride NICNAS submitted an application to create a new Schedule 6 entry for 1,3-bis(2,4-diaminophenoxy)propane tetrahydrochloride in hair dyes and eyebrow/eyelash colouring products and to determine whether an appropriate exemption cut-off is required.
o-Toluidine and o-anisidine NICNAS submitted an application to create new entries for o-toluidine and o-anisidine in Schedule 10 for use in preparations for skin colouration (including tattooing) and dyeing of hair, eyelashes or eyebrows.
1-Deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives NICNAS submitted an application to create a new Schedule 6 entry for 1-deoxy-1-(methylamino)-D-glucitol N-coco acyl derivatives, to consider if an exemption cut-off for rinse-off cosmetics and household cleaning products is appropriate.
Abamectin APVMA submitted an application to amend the existing schedule 5 entry for abamectin to accommodate preparations containing 0.05 per cent or less of abamectin in a gel formulation.
Pegbovigrastim APVMA submitted an application to determine whether pegbovigrastim requires scheduling.
2. Delegate-initiated proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS) for scheduling advice.
Substance Proposal
Guanfacine hydrochloride The delegate proposes a new Appendix K entry for guanfacine hydrochloride
Tianeptine The delegate proposes a new Schedule 4 entry for tianeptine.

Timetable

Document released for consultation on Thursday 22 September 2016.

Interested parties should respond by close of business Thursday 20 October 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 (Chemicals) 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; and/or
  • 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 website unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

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

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

Privacy information

  • The TGA collects your personal information in this submission for the following reasons:
    • 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; and
    • To 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 website (i.e. make this information publicly available) if you consent to the publication of your name on the TGA website (please complete the cover sheet).
  • 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 .