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Scheduling delegate's final decisions: Cannabis, May 2017
Scheduling medicines and poisons
Notice under subsections 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations)
The delegates of the Secretary to the Department of Health hereby give notice of delegate's final decisions for amending the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons - SUSMP) under subsection 42ZCZS 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 November 2016 meeting of the Joint Advisory Committee on Chemicals and Medicines Scheduling (Joint ACCS-ACMS#14)
Scheduling proposals referred to the expert advisory committees
Pre-meeting public notice
On 22 September 2016, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published a pre-meeting public notice Consultation: Proposed Amendments to the Poisons Standard - Joint ACCS and ACMS meeting, November 2016 on the TGA website which specified the proposed amendments to the current Poisons Standard and invited public comment.
The pre-meeting consultation period was open for public comment for 20 business days and closed on 20 October 2016.
In accordance with subsection 42ZCZL of the Regulations redacted versions of public submissions will be published at Public submissions on scheduling matters on or after the date of this notice.
November 2016 Joint ACCS-ACMS#14
On 2 February 2017, in accordance with subsection 42ZCZN of the Regulations, the delegate made an interim decision on an application and under subsection 42ZCZP of the Regulations, the scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, November 2016 and the reasons for the decision was published on TGA website. Further submissions were also invited from the applicants and parties who made valid pre-meeting submissions. The inivitation to make submissions was open for 10 business days and closed on 16 February 2017.
Redacted versions of public submissions will be published at Public submissions on scheduling matters on or after the date of this notice.
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
According to subsections 42ZCZT/42ZCZU of the Regulations 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 Chemicals and Medicines (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 (SUSMP) prior to the date of effect (implementation date) of the final decisions. Further information, including links to the Poisons Standard on FRL, is available at SUSMP.