Scheduling delegate's final decisions: ACCS, October 2014

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Scheduling medicines and poisons

28 October 2014

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 delegates' 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 March 2014 joint meeting of the ACCS and the ACMS (joint ACCS-ACMS 8);
  • scheduling proposals initially referred to the July 2014 joint meeting of the ACCS and the ACMS (joint ACCS-ACMS 9); 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 for the March joint meeting on 30 January 2014 at: Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, March 2014 and for the July joint meeting on 29 May 2014 at: Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, July 2014.

No public submissions were received for the March joint meeting. Edited versions of the public submissions received for the July joint meeting in response to this invitation were published on 30 September 2014 at: Public submissions on scheduling matters referred to the ACCS#11 and the joint ACCS-ACMS#9.

Interim decisions

The delegates' interim decisions on recommendations by the joint ACCS-ACMS 8 and 9 were published for the March meeting on 27 June 2014 at: Reasons for scheduling delegate's interim decision and invitation for further comment for the ACCS and the Joint ACCS-ACMS, June 2014 and for the July meeting on 30 September 2014 at: Reasons for scheduling delegate's interim decision and invitation for further comment for the ACCS and the Joint ACCS-ACMS, September 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 these public submissions received in response to this invitation are published at: Public submissions on scheduling matters.

Final decisions

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.

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, 2010).

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 The Poisons Standard (the SUSMP).

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