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Scheduling delegate's final decisions. ACMS/ACCS, December 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 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 August 2015 joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling (joint ACMS-ACCS#11);
- 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 28 May 2015 at Consultation: Invitation for public comment - ACCS meeting and joint ACCS/ACMS meeting, July 2015.
Edited versions of these public submissions received in response to this invitation were published on 1 October 2015 at Public submissions on scheduling matters.
The delegates' interim decisions on recommendations by the joint ACMS-ACCS #11 were published on 1 October 2015 at Reasons for scheduling delegate's interim decisions and invitation for further comment for the ACCS#14 and ACCS/ACMS#11. 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 1 October 2015 and are available at Public submissions on scheduling matters.
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, 2015).
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 as amendments 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).
Table of contents
- 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
- 2. New Chemical Entities - Medicines for human therapeutic use