Scheduling delegate's final decisions: ACCS, November 2015
Scheduling medicines and poisons
Notice under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)
A delegate of the Secretary to the Department of Health hereby gives notice of the delegate's 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 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 2015 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#13);
- scheduling proposals initially referred to the August 2015 meetings of the Advisory Committee on Chemicals Scheduling (ACCS#14); 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 notice
A 'pre-meeting' public notice inviting submissions on the scheduling proposals referred to the expert advisory committees was published on 29 January 2015 and the second public notice was published on 4 June 2015 at Consultation Invitation for March 2015 meeting and March 2015 Delegate's Interim Decisions and Consultation Invitation, respectively.
Edited versions of the public submissions received in response to the invitation were published on 4 June 2015 at Public Submissions Scheduling Matters.
The delegate's interim decisions, on recommendations by the ACCS#13 and ACCS#14, were published on 4 June 2015 and 1 October 2015 respectively on the TGA website. 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.
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, may not have been considered by the delegate.
Edited versions of valid public submissions received in response to the interim decisions will be published after 19 November 2015 and will be available at Chemical Scheduling Submissions.
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 and relevant information received in response to the interim decisions.
Matters not referred to an advisory committee
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 Medicines and Chemicals (SPF, 2015), available at Scheduling Policy Framework.
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 ComLaw. Further information, including links to the Poisons Standard on ComLaw, is available at Poisons Standard.
Privacy and your personal information
Your personal information is protected by law, including the Privacy Act 1988. It is collected by the Australian Government Department of Health for the purpose of identifying the person making a submission as part of the public invitation process, and contacting that person about their submission, for example to seek clarification of issues raised in submissions.
The consequence of not providing your personal information may result in the Department being unable to communicate with you about your submission.
The Department is unlikely to disclose your personal information it has collected as part of the public comment process to any other Department, body or person or to overseas recipients.
Table of contents
- Part A - Final decisions on matters referred to an expert advisory committee
- 1. Scheduling proposals referred to the March 2015 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#13)
- 2. Scheduling proposals referred to the August 2015 ACCS meeting
- Summary of delegate's final decisions
- 2.1 Cyclopropylmethyl, 3-hexenoate
- 2.2 Bicyclopyrone
- 2.3 Clitoria ternatea extract
- 2.4 Cyclopentanepropanol, alpha,alpha- dimethylpropanol
- 2.5 Hydramethylnon
- 2.6 Momfluorothrin
- 2.7 Carcinogenic amines (azo dyes)
- 2.8 Quinoline, 5,6,7,8-tetrahydro-8-(1-methylpropyl)
- 2.9 4-amino-m-cresol (Phenol, 4-amino-3-methyl)
- 2.10 4-amino-2-hydroxytoluene (Phenol, 5-amino-2-methyl)
- 2.11 2-amino-6-chloro-4-nitrophenol (Phenol, 2-amino-6-chloro-4-nitro)
- Part B - Final decisions on matters not referred to an expert advisory committee