Delegate-only final decisions and reasons: NCEs, September 2019

Scheduling amendments not referred to expert advisory committee

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 the Secretary decides to make a final decision in relation to the proposed amendment without an interim decision. If the final decision is to amend the current Poisons Standard, the Secretary 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 Medicines and Chemicals.

In accordance with 42ZCZX of the Regulations, the Secretary publishes here the scheduling final decision, the reasons for that decision and the date of effect (for 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). These Secretary's final decisions and reasons related to new therapeutic prescription only medicines known as New Chemical Entities.

Contents

• Final decisions on matters not referred to an expert advisory committee
  • 1. New Chemical Entities - medicines for human therapeutic use
    • 1.1 Lorlatinib
    • 1.2 Niraparib
    • 1.3 Risankizumab
    • 1.4 Darolutamide
    • 1.5 Alpelisib
    • 1.6 Linaclotide