Examples – Type 14 – Item 14 (Vet): Scenario 1

Scenario 1: Change in product formulation involving a new solvent that changes the viscosity of a pour-on product

Objective

An application is made to vary the formulation of a registered pour-on parasiticide for use in food producing animals (cattle and sheep) to substitute one solvent for another.

The new solvent is a major component of the formulation (90 per cent). The change will alter the viscosity of the product.

The applicant sought Pre-Application Assistance because of the significant change and was advised that the new solvent has some minor health risks to humans and may require changes to the label instructions for use, re-handling and first aid. Residues assessment will also be required to assess if a change to the withholding periods is necessary.

Target animal efficacy and safety studies are also required to demonstrate comparable efficacy with the previously approved formulation.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the change in formulation will not affect the product’s capacity to meet the statutory criteria.

As the formulation change will result in changes to the label (safety directions and first aid instructions), an updated label must be included in the application.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this variation. Modules 1, 11 and 12 are mandatory modules for this application.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

An assessment is required to ensure the proposed formulation changes are acceptable.

2.3

6 months

$1 954

3: Toxicology

An assessment is required to establish the toxicological profile of the new formulation.

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

An assessment is required as the change to the product formulation is expected to alter residue risks and requires an assessment of withholding periods or MRLs.

5.4

4 months

$7 465

6: Work health and safety

An assessment is required to establish new safety directions and precautionary statements.

6.3

4 months

$3 913

7: Environment

No assessment required as there is no change to environmental risk.

8: Efficacy and safety

An assessment is required to ensure changes to product formulation do not affect target animal safety and the efficacy of the product.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as formulation change does not alter risks related to non-food trade.

10: Special data

No assessment required as this product is not an antibiotic or GMO.

11: Finalisation

11.1

3 months

$8 110

12: Limits on use (data protection)

12

N/A

$460

Total

 

9 months

$28 014

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Examples