Scheduling delegate's final decisions, January 2017
Scheduling of medicines and poisons
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 and 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.
Table of contents
- Final decisions on matters not referred to an expert advisory committee
- 1. Chemicals not referred to the November 2016 ACCS
- New Chemical Entities – medicines for human therapeutic use
- Summary of delegate's final decisions
- 2.1. Ocrelizumab
- 2.2. Eluxadoline
- 2.3. Cobimetinib
- 2.4. Lenvatinib
- 2.5. Talimogene laherparepvec
- 2.6. Dermatophagoides pteronyssinus and Dermatophagoides farinae extract
- 2.7. Fomepizole
- 2.8. Sarilumab
- 2.9. Osimertinib
- 2.10. Lipegfilgrastim
- 2.11. Elotuzumab
- 2.12. Ixazomib
- 2.13. Lumacaftor
- 2.14. Sodium zirconium cyclosilicate
- 2.15. Sonidegib
- 2.16. Venetoclax
- 2.17. Carfilzomib