Part A - Final decisions on matters referred to an expert advisory committee (November 2018)
1. Advisory Committee on Medicines Scheduling (ACMS #25)
1.2. Racetams
On this page: Delegate's final decision | Public submissions on the interim decision | Interim decision | Scheduling proposal
Note
New text is shown as green, larger font, with a horizontal line above it.
Delegate's final decision
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
RACETAMS except when separately specified in these Schedules.
ANIRACETAM.
COLURACETAM.
DIMIRACETAM.
FASORACETAM.
METHYLPHENYLPIRACETAM.
NEBRACETAM.
NEFIRACETAM.
OMBERACETAM.
OXIRACETAM.
PHENYLPIRACETAM.
PRAMIRACETAM.
ROLZIRACETAM.
SELETRACETAM.
SUNIFIRAM.
UNIFIRAM.
Appendix K - New entry
SELETRACETAM
Index - New Entries
RACETAMS
Schedule 4
ANIRACETAM
cross reference: RACETAMS
Schedule 4
COLURACETAM
cross reference: RACETAMs
Schedule 4
DIMIRACETAM
cross reference: RACETAMS
Schedule 4
FASORACETAM
cross reference: RACETAMS
Schedule 4
METHYLPHENYLPIRACETAM
cross reference: RACETAMS
Schedule 4
NEBRACETAM
cross reference: RACETAMS
Schedule 4
NEFIRACETAM
cross reference: RACETAMS
Schedule 4
OMBERACETAM
cross reference: RACETAMS
Schedule 4
OXIRACETAM
cross reference: RACETAMS
Schedule 4
PHENYLPIRACETAM
cross reference: RACETAMS
Schedule 4
PRAMIRACETAM
cross reference: RACETAMS
Schedule 4
ROLZIRACETAM
cross reference: RACETAMS
Schedule 4
SELETRACETAM
Cross reference RACETAMS
Schedule 4
Appendix K
Schedule 4
SUNIFIRAM
cross reference: RACETAMS
Schedule 4
UNIFIRAM
cross reference: RACETAMS
Index - Amended Entries
BRIVARACETAM
cross reference: RACETAMS
Schedule 4
Appendix K
LEVETIRACETAM
cross reference: RACETAMS
Schedule 4
Appendix K
PIRACETAM
cross reference: RACETAMS
Schedule 4
Implementation date: 1 June 2019
Reasons
The reasons for the final decision remain the same as for the interim decision.
Public submissions on the interim decision
Nil received.
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.
Scheduling proposal
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.