Examples – Type 15 – Item 14 (Vet): Scenario 2

Scenario 2: Variation to change the dose and dosage frequency for an antibiotic product

Objective

An application is made to change the dose and frequency of an intravenous injection antibiotic product used in horses.

Current label instructions

Proposed new label instructions

Horses: 2.5 mg/kg twice daily by intravenous injection.

Horses: 8.0 mg/kg once daily by slow intravenous injection.

The applicant has provided safety, efficacy and pharmacokinetics data to support the application.

An updated label with the new dosing regime 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 not required as the use is in a non-food species. The label already has a restraint to prevent use in food producing animals.

6: Work health and safety

No assessment is required as human exposure is not expected to change as a result of the variation to the dose.

7: Environment

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

8: Efficacy and safety

An assessment is required to ensure the change in dose is safe and efficacious for horses

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 there is no increased risk of antibiotic resistant from the changed use pattern.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

6 months

$6 402

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Examples