Reasons for scheduling delegates' final decisions, February 2013

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Scheduling medicines and poisons

22 November 2013

Notice under subsections 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)

A delegate of the Secretary to the Department of Health and Ageing 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 delegates' final decisions and reasons relate to:

  • scheduling proposals initially referred to the October 2012 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#6);
  • scheduling proposals initially referred to the October 2012 meeting of the Advisory Committee on Medicines Scheduling (ACMS#7);
  • scheduling proposals initially referred to the October 2012 joint meeting of the ACCS and the ACMS (joint ACCS-ACMS#4);
  • 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 14 August 2012 at Invitation for public comment - ACMS and ACCS meetings, October 2012.

Redacted versions of the public submissions received in response to this invitation were published on 10 January 2013 at Public submissions on scheduling matters referred to ACCS #6, the joint ACCS and ACMS #4 and ACMS #7 (October 2012).

Interim decisions

The delegates' interim decisions on recommendations by the ACCS#6, ACMS#7 and joint ACCS-ACMS#4 were published on 7 January 2013 at Reasons for scheduling delegate's interim decision and invitation for further comment, January 2013. 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.

Redacted versions of valid public submissions received in response to the interim decisions were published on 10 January 2013 at Public submissions on scheduling matters referred to ACCS #6, the joint ACCS and ACMS #4 and ACMS #7 (October 2012).

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 (SPF).

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 and in a hardcopy Amendment to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on ComLaw, is available at The Poisons Standard (the SUSMP).

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