Examples – Type 15 – Item 14 (Vet): Scenario 3

Scenario 3: Variation to increase the dose rate for a sheep drench product and to increase the interval between treatments

Objective

An application is made to increase the dose rate of a sheep drench product to allow a claim that the product will remain effective for a longer period of time between treatments.

The applicant has provided data on the efficacy and safety of the higher dose. Meat and milk WHP and ESI will need to be amended and residues data has been submitted at the new dose and frequency. No changes to MRLs are proposed.

An updated label with the new dose rate and dosing interval has also been provided.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to meet the safety and efficacy criteria.

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

An assessment is required to review WHPs and ESIs at the new dose rate and frequency.

5.4

4 months

$7 465

6: Work health and safety

No assessment required. Due to the method of application (syringe), worker exposure is not expected to change.

7: Environment

No assessment is required as the overall exposure to the environment is not expected to change.

8: Efficacy and safety

Assessment is required to assess if the new dose and dosing interval is safe and effective for the target animal

8.2

4 months

$1 950

9: Non-food trade

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

10: Special data

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

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

6 months

$13 867

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