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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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2.2 Vinyl acetate

Part A: Amendments to the Poisons Standard referred to an expert advisory committee

Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #18)

2.1 Name

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 6 entry for vinyl acetate in the Poisons Standard as follows:

Schedule 6 - Amend Entry

VINYL ACETATE MONOMER (excluding its derivatives) except:

  1. in preparations for therapeutic use; or
  2. in cosmetic preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer; or
  3. in other preparations containing 1 per cent or less of vinyl acetate.
Implementation date: 1 October 2018

The delegate has decided that the implementation date of 1 October 2018, to replace the 31 October 2017 decision, is reasonable and appropriate in the circumstances.

Reasons:

As no new evidence has been received to alter the interim decision for vinyl acetate, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.

Public submissions on the interim decision

One (1) public submission was received before the second closing date in response to an invitation published on 7 June 2018 under regulation 42ZCKP of the Regulations. The public submission supported the interim decision for vinyl acetate.

The main point provided in support of the amendment was:
  • A thorough analysis was taken and a pragmatic outcome was achieved to ensure a balanced regulatory framework is maintained on vinyl acetate.

The public submission will be made available on the TGA website at Public submissions on scheduling matters.

Interim decision

The interim decision for vinyl acetate was published on the TGA website on 7 June 2018 at Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018 - 2.2 Vinyl acetate.

Scheduling proposal

The pre-meeting scheduling proposal for vinyl acetate was published on the TGA website on 21 December 2017 at Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018.

Book pagination