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Scheduling delegate's final decisions: ACMS, October 2014
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 delegate's final decisions and reasons relate to:
- scheduling proposals initially referred to the July 2014 meeting of the Advisory Committee on Medicines Scheduling (ACMS#12 );
- scheduling proposals considered as delegate-only matters, i.e. not referred to an expert advisory committee.
Pre-meeting public notice
A 'pre-meeting' public notice inviting submissions on the scheduling proposals referred to the expert advisory committees was published on 3 April 2014 at Consultation: Invitation for public comment - ACMS meeting, July 2014 and Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, July 2014, respectively.
Edited versions of these public submissions received in response to this invitation were published on 18 September 2014 at Public submissions on scheduling matters referred to the ACMS#12 (July 2014).
The delegate's interim decisions on recommendations by the ACMS#12 were published on 18 September 2014 at Reasons for scheduling delegate's interim decision and invitation for further comment for the ACCS and the Joint ACCS-ACMS, June 2014. 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 be considered by the delegate.
Edited versions of valid public submissions received in response to the interim decisions were published on 23 October 2014 and are available at Reasons for scheduling delegate's interim decisions & invitations for further comment.
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 received in response to the interim decisions.
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, 2010).
The amendments to the Schedules, Appendices or other parts of the Poisons Standard are published electronically on ComLaw as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) The Poisons Standard (the SUSMP).
- Part A - Final decisions on matters referred to an expert advisory committee
- Part B - Final decisions on matters not referred to an expert advisory committee