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Final decisions and reasons for NCEs, medicines and chemicals, November 2018
Scheduling medicines and poisons
Part A - Final decisions on matters referred to an expert advisory committee (November 2018)
1. Advisory Committee on Medicines Scheduling (ACMS #25)
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Delegate's final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to racetams as follows:
Schedule 4 - New Entries
Appendix K - New entry
Index - New Entries
Index - Amended Entries
Implementation date: 1 June 2019
The reasons for the final decision remain the same as for the interim decision.
Public submissions on the interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 – 1.2 Racetams.
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, November 2018.