Examples – Type 15 – Item 14 (Vet): Scenario 5

Scenario 5: Variation to the application method to use hand jetting in a product approved for automatic jetting

Objective

An application is made to vary a fly and lice control product in sheep to provide directions for use by hand jetting. The product is registered for this use by automatic jetting.

The applicant has provided scientific argument that the proposed application method is as effective and safe as the approved application method.

The applicant has provided an updated label with the instructions.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product’s capacity to meet the safety (Section 5A) criterion will not be affected by the increased application rate.

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 extension. Modules 1, 11 and 12 are mandatory modules for this application.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to one month

$902

2: Chemistry

No assessment required as the product is currently registered and no change is proposed to the product chemistry.

3: Toxicology

No assessment required as the product is currently registered and relevant health standards are already established. No new information provided.

4: Toxicology – Poison scheduling

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

No assessment required as the application rate is not changing.

6: Work health and safety

Assessment required to determine exposure for users and consider existing safety directions and PPE. No additional data is required.

6.2

7 months

$3 185

7: Environment

No assessment is required as the changed application method does not increase the environmental risk.

8: Efficacy and safety

An assessment is required to show efficacy and safety by the alternate application method (scientific argument provided).

8.3

3 months

$1 160

9: Non-food trade

No assessment required as there are no changes to the product risks to non-food trade.

10: Special data

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

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12

N/A

$460

Total

 

9 months

$8 797

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Examples