Notice under subsection 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations)
The delegate 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 42ZCZX 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 considered as delegate-only matters, i.e. not referred to an expert advisory committee.
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 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 the Federal Register of Legislation (FRL), is available at SUSMP.
Amendment to delegate-only final decisions not referred to an expert advisory committee
On 16 January 2017, the delegate made four delegate-only decisions. Following the release of the final decisions, feedback from industry indicated that some of the chemicals are used more broadly than initially considered. Hence, these four delegate-only decisions will undergo review to enable further consideration of their broader use pattern. It is anticipated that scheduling advice will be sought from the Advisory Committees on Medicines and Chemicals Scheduling (ACMS/ACCS).