Invitation for public comment - ACCS meeting, March 2013

This consultation closed on 7 March 2013.

Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990

The delegate of the Secretary of the Department of Health and Ageing 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.¹

Accordingly, the following 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.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (Word or unsecured PDF) to the email address provided below by 7 March 2013.

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 23 May 2013. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegates' interim decision.

The current Poisons Standard is available at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au.

---

Footnote

1. Notice inviting public submissions for the general scheduling applications was published on 29 November 2012 with the public comments due on 17 January 2013.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)

Substance	Scheduling proposal
Abamectin	Proposal to amend only the abamectin Schedule 6 (a) entry to raise the cut-off from 2 to 4 per cent or less of abamectin.
Carbonyl sulfide	Proposal for new Schedule 7 and Appendix J entries for carbonyl sulfide.
Chlorfenapyr	Proposal for a new Schedule 5 entry for preparations containing 0.5 per cent or less chlorfenapyr, with consequent amendments to the current Schedule 7 and Schedule 6 entries.
Eubacterium sp.	Proposal for a new Schedule 5 entry for Eubacterium sp.
Pyroxasulfone	Proposal to delete the current pyroxasulfone Schedule 7 entry and amend the current Schedule 6 entry to a simple entry with no exemptions.
Sulfoxaflor	Proposal for new Schedules 6 and/or 5 entries for sulfoxaflor.

2. Proposed amendments referred by the delegate for scheduling advice for consideration by the joint meeting of the Advisory Committee on Chemicals Scheduling (ACCS) & the Advisory Committee on Medicines Scheduling (ACMS).

Item	Proposal
Part 1, Interpretation	Advice on inclusion of terms, such as synthetic, analogue and derivative, to the Part 1, Introduction in order to better define these terms, their intent and purpose.

Top of page