Examples – Type 15 – Item 14 (Vet): Scenario 1

Scenario 1: Variation to increase the dose of a euthanasia solution

Objective

An application is made to increase the dose of an intravenous (IV) product used for the euthanasia of various animals. The dose is being increased from 2 mg/kg to 3 mg/kg. 

The applicant has nominated a reference product (which has no relevant protected data) and provided scientific argument as how the product will continue to meet the statutory criteria once the variation is made.

The applicant has provided an updated label with the new dose rate.

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) and efficacy (Section 5B) criterion will not be affected by the increased dosage.

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 increased dose is related to a non-food use.

6: Work health and safety

No assessment is required as the increased dose does not change the risks previously assessed for human health.

7: Environment

No assessment is required as the increased dose does not change the risks previously assessed for the environment.

8: Efficacy and safety

Assessment is required to evaluate the scientific argument in comparison to the reference product information to support the increased dose. 

8.2

4 months

$1 950

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)

12.0

N/A

$460

Total

 

6 months

$6 402

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Examples