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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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3.3 Eprinomectin

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

3. Advisory Committee on Chemicals Scheduling (ACCS #22)

3.3 Eprinomectin

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Poisons Standard by creating a new Schedule 6 entry for eprinomectin and amending the Schedule 7 entry to reflect this change as follows:

Schedule 6 - New Entry

EPRINOMECTIN for internal use in preparations containing 5 per cent or less of eprinomectin except when included in Schedule 5.

Schedule 7 - Amend Entry

EPRINOMECTIN except when included in Schedule 5 or 6.

The Schedule 5 entry remains as follows:

Schedule 5 - Current Entry

EPRINOMECTIN in preparations containing 0.5 per cent or less of eprinomectin.

Implementation date: 1 October 2018
Reasons:

The delegate notes the public submission on the interim decision but has decided not to alter the interim decision for eprinomectin because the acute toxicity data for eprinomectin (specifically the oral and dermal toxicity and eye irritation) are consistent with the Schedule 6 criteria of the Scheduling Policy Framework.

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 opposed the interim decision, instead supporting of inclusion of the injectable eprinomectin product in Schedule 5. The submission suggested the following alternative wording for the Schedule 5 entry:

EPRINOMECTIN

  1. in preparations containing 0.5 per cent or less of eprinomectin;
  2. in preparations for internal use containing 5 per cent or less of eprinomectin.
Interim decision

The interim decision for eprinomectin 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 - 3.3 Eprinomectin.

Scheduling proposal

The pre-meeting scheduling proposal for eprinomectin 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.

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