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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

9 April 2018

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3.1 Fluralaner

Part A - Final decisions on matters referred to an expert advisory committee (November 2017)

3. Advisory Committee on Chemicals Scheduling (ACCS #21)

3.1 Fluralaner

Delegate's final decision
Final decision:

The delegate's final decision is to amend the current Schedule 5 entry for fluralaner as follows:

Schedule 5 - Amend Entry

FLURALANER.

Index - Amend Entry

FLURALANER
cross-reference: CARBAMOYL BENZAMIDE PHENYL ISOXAZOLINE

Schedule 5

Implementation date: 1 June 2018
Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

  1. the risks and benefits of the use of a substance:
    • Benefit: fluralaner shows longer-lasting flea and paralysis tick prevention compared to other available products.
    • Risks: there is uncertainty around the human exposure risk and indirect exposure from contact with treated animals.
  2. the purposes for which a substance is to be used and the extent of use of a substance:
    • Spot-on flea treatments are in wide use and the public are familiar with the application process.
  3. the toxicity of a substance:
    • Fluralaner has a sufficiently low acute toxicity profile to be consistent with the Schedule 5 criteria of the Scheduling Policy Framework.
  4. the dosage, formulation, labelling, packaging and presentation of a substance:
    • Nil
  5. the potential for abuse of a substance:
    • Nil
  6. any other matters that the Secretary considers necessary to protect public health:
    • Nil
Public submissions on the interim decision

One (1) public submission was received that opposed the interim decision for fluralaner.

The main points opposed were:
  • The recommendations of the Australian Pesticides and Veterinary Medicines Authority (APVMA) in its final Human Health Risk Assessment Technical Report are consistent with a Schedule 5 entry.
  • A Schedule 5 entry is consistent with the scheduling of other members of the isoxazoline class and other currently registered topical parasiticides for pets.
  • The assessment of human exposure risk and indirect exposure from contact with treated animals, for which the APVMA has now completed its evaluation, does not support inclusion in Schedule 4.
  • The new topical formulation proposed does not present additional risks over the existing oral formulation.
  • The new data and new formulation provide no reason to depart from the previous scheduling decision including because:
    • the toxicology package continues to indicate that fluralaner has a sufficiently low acute toxicity profile to be consistent with Scheduling Policy Framework criteria for listing in Schedule 5;
    • the proposed presentation for the topical fluralaner product continues to support an assessment that acute poisoning risk to humans (in particular children) is low; and
    • there is no basis to consider that treatment with the proposed topical fluralaner product requires the oversight of a veterinarian, whether in diagnosis or management of treatment.
  • The proposed scheduling, while different from some international jurisdictions (as was recognised in the October 2014 scheduling decision for fluralaner), remains appropriate in Australia when the context of the different regulations and regulatory frameworks is taken into account.
Interim decision

The interim decision for fluralaner was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 3.1. Fluralaner.

Scheduling proposal

The pre-meeting scheduling proposal for fluralaner was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.

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