Scheduling delegate's final decisions, June 2016

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Scheduling of medicines and poisons

23 June 2016

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 March 2016 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#16);
  • scheduling proposals initially referred to the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#17);
  • scheduling proposals initially referred to the March 2016 Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS#12); 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 on 11 November 2015 and 10 December 2015 on the TGA website at: Public notice about scheduling.

Edited versions of public submissions received in response the invitation were published on 12 May 2016 at: Public submissions on scheduling matters. Redacted versions of public submissions received in response to ACMS items will be published on or after the date of this notice.

Interim decisions

The delegates' interim decisions on recommendations by the ACCS #16, ACCS-ACMS#12 and ACMS #17 were published on 12 May 2016 at Reasons for Delegate's interim decisions and invitation for further comment. 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 will be 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, 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 the Federal Register of Legislation (FRL) as amendments to the Standard for the Uniform Scheduling of Medicines and Poisons prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on the Federal Register of Legislation (FRL).

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