Scheduling delegate's final decisions, June 2017

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

The delegates of the Secretary to the Department of Health hereby give 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/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 2017 meeting of the Advisory Committee on Medicines Scheduling (ACMS#20);
• scheduling proposals initially referred to the March 2017 Joint meeting of the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS#15);
• scheduling proposals initially referred to the March 2017 meeting of the Advisory Committee on Chemicals Scheduling (ACCS#19); 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 notices

On 22 December 2016 and 3 February 2017, under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations), the delegate published pre-meeting public notices on the TGA website which specified the proposed amendments to the current Poisons Standard. The notices also invited public comment on the scheduling proposals referred to the expert advisory committees.

The pre-meeting consultation periods were open for public comment for 20 business days and closed on 10 February 2017 and 3 March 2017, respectively.

In accordance with subsection 42ZCZL of the Regulations, redacted versions of public submissions received in response to these invitations for public comment will be published on or after the date of this notice on the TGA website at Public submissions on scheduling matters.

Interim decisions

On 17 May 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 interim decision 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 31 May 2017.

Redacted versions of public submissions will be published at Public submissions on scheduling matters on or after the date of this notice.

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

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), available at SPF, February 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.