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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

Book pagination

1.2 Racetams

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

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.

Book pagination