Scheduling delegate's final decisions, January 2018

Final scheduling decisions and reasons for decisions by delegates of the Secretary to the Department of Health for matters not referred to an advisory committee (Delegate-Only decisions)

Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides not to refer the proposed amendment to an expert advisory committee.  These include, under regulation 42ZCZU, that if the Secretary decides to amend the current Poisons Standard in the manner set out in such an application, the Secretary may make a final decision without making an interim decision.  Following publication of the final decision in accordance with regulation 42ZCZX, if the final decision is to amend the current Poisons Standard, the delegate must, in doing so, take into account the matters mentioned in subsection 52E(1) of the  Act (including, for example, the risks and benefits of the use of a substance, and the potential for abuse of a substance) and the scheduling guidelines as set out in the Scheduling Policy Framework for Chemicals and Medicines (SPF, 2015), available on the TGA website.

Under 42ZCZX of the Regulations, the Secretary must, among other things, publish (in a manner the Secretary considers appropriate) the final scheduling decision, the reasons for that decision and the date of effect of the decision (for final decisions to amend the current Poisons Standard, this will be the date when it is expected that the current Poisons Standard will be amended to give effect to the decision. The Poisons Standard is published electronically on the Federal Register of Legislation (FRL). Further information, including links to the Poisons Standard on FRL, is available on the TGA website.

Table of contents

• New Chemical Entities – medicines for human therapeutic use
• Summary of delegate’s final decisions
• 1.1 Alectinib
• 1.2 Apalutamide
• 1.3 Bictegravir flagrans
• 1.4 Binimetinib
• 1.5 Cabozantinib amyloliquefaciens
• 1.6 Cinnarizine
• 1.7 Encorafenib
• 1.8. Erenumab
• 1.9. Ertugliflozin
• 1.10. Ferric derisomaltose
• 1.11. Insulin degludec
• 1.12. Letermovir
• 1.13. Nusinersen
• 1.14. Patiromer sorbitex calcium
• 1.15. Peramivir
• 1.16. Recombinant varicella zoster virus glycoprotein E antigen
• 1.17. Reslizumab
• 1.18. Ribociclib
• 1.19. Tafenoquine succinate
• 1.20. Telotristat ethyl
• 1.21. Tipiracil
• 1.22. Trifluridine