Examples – Type 15 – Item 14 (Vet): Scenario 4

Scenario 4: Changing the duration of immunity on a vaccine product

Objective

An application is made to vary a vaccine product for use in dogs to amend the dosage and administration section of the label including the duration of immunity. The proposed change will require a booster vaccination after 3 years instead of 12 months.

The applicant has submitted a safety and efficacy study with the new dose regime as well as scientific argument.

An updated label has been provided.

Current label instructions

Proposed new label instructions

Revaccination:

An annual booster is recommended

Revaccination:

A single dose vaccine should be given at intervals of up to 3 years following the primary vaccination program.

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 product is for use in dogs.

6: Work health and safety

No assessment required as the user risk has not changed.

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 ensure the change in vaccination schedule is safe and efficacious for dogs.

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

Not required.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

6 months

$6 402

Heading: 
Examples