Examples – Type 15 – Item 14 (Vet): Scenario 6

Scenario 6: Variation to the route of administration for an anaesthetic for companion animals from intravenous injection to intramuscular injection

Objective

An application is made to change the route of administration for an anaesthetic from intravenous to intramuscular.

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

An updated label with the new instructions for intramuscular injection 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

No assessment required as the use is a non-food use. Assessment of the residues at the site of injection would be required for a food producing species.

6: Work health and safety

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

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 demonstrate that the new route of administration is safe and effective.

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 an antibiotic or 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