Final scheduling decisions and reasons: NCEs and Appendix H

Publication of decisions pursuant to regulation 42ZCZX of the Therapeutic Goods Regulations 1990

In accordance with regulation 42ZCZX, this notice gives effect to the Secretary’s obligation to publish the final decisions, the reasons for those decisions and the date of effect of decisions made pursuant to regulations 42ZCZU or 42ZCZW of the Therapeutic Goods Regulations 1990.

The final decisions to which this notice relates include decisions made with respect to new therapeutic Prescription Only medicines known as New Chemical Entities (NCEs) which were not referred to an expert advisory committee. This notice also includes delegate approved changes to Appendix H.

Contents

Part A - Final decisions on matters not referred to an expert advisory committee

1. Delegate-only decisions on Schedule 3 substances to be added to Appendix H of the Poisons Standard 3
   • 1.1. Appendix H
2. New Chemical Entities - medicines for human therapeutic use
   • 2.1. Crisaborole
   • 2.2. Brigatinib
   • 2.3. Lanadelumab
   • 2.4. Romosozumab