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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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3.2 Moxidectin

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

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

3.2 Moxidectin

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedules 6 and 4 entries for moxidectin in the Poisons Standard as follows:

Schedule 6 - Amend Entry

MOXIDECTIN:

  1. in preparations for external use containing 2.5 per cent or less of moxidectin when packed in single dose tubes for the treatment of cats and dogs; or
  2. in preparations for external use containing 2 per cent or less of moxidectin for the treatment of animals; or
  3. in preparations for internal use containing 10 per cent or less of moxidectin for the treatment of sheep or cattle,

    except when included in Schedule 5.

Schedule 4 - Amend Entry

MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin except when included in Schedule 5 or 6.

Implementation date: 1 October 2018
Reasons:

As no new evidence has been received to alter the interim decision for moxidectin, 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

No public submissions were received before the second closing date in response to an invitation published on 7 June 2018 under regulation 42ZCKP of the Regulations.

Interim decision

The interim decision for moxidectin 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 - 3.2 Moxidectin.

Scheduling proposal

The pre-meeting scheduling proposal for moxidectin 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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