Scheduling delegate's final decisions: ACCS/ACMS, November 2013
Scheduling medicines and poisons
Notice under subsections 42ZXZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)
A delegate of the Secretary to the Department of Health hereby gives notice of 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 Regulations. This notice also provides the reasons for each decision and the date of effect of the decision.
The delegates' final decisions and reasons relate to:
- scheduling proposals initially referred to the July 2013 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#8);
- scheduling proposals initially referred to the July 2013 meeting of the Advisory Committee on Medicines Scheduling (ACMS#9);
- scheduling proposals initially referred to the July 2013 joint meeting of the ACCS and the ACMS (joint ACCS-ACMS#6);
- 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
- The first 'pre-meeting' public notice inviting submissions on the scheduling proposals referred to the expert advisory committees was published on 24 April 2013 at Invitation for public comment - ACMS meeting, July 2013 and the second public notice was published on 13 June 2013 at Consultation: Invitation for public comment - ACCS and joint ACCS/ACMS meetings, July 2013.
- Redacted versions of the public submissions received in response to this invitation were published on 23 May 2013 at Public submissions on scheduling matters referred to ACCS #8, ACMS #9 and the joint ACCS-ACMS #6 (July 2013).
- The delegates' interim decisions on recommendations by the ACCS#8, ACMS#9 and joint ACCS-ACMS#6 were published on 26 September 2013 at Reasons for scheduling delegate's interim decision and invitation for further comment, July 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 public submissions received in response to the interim decisions were published on 8 November 2013 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 application to an expert advisory committee for advice and instead may make a delegate-only decision. When deciding not to refer an application to an expert advisory committee for advice, the delegate considers the scheduling guidelines as set out in the Scheduling Policy Framework (SPF).
The SUSMP and its amendments are available electronically at the ComLaw website, a link to which can be found at The Poisons Standard (the SUSMP).