Scenario 2: Variation to the shelf life of a registered veterinary product (no e-label required)
Objective
An application is made to extend the current shelf life for a canine ear gel from two to three years. The applicant has undertaken stability studies that demonstrate the product continues to meet the product specifications for up to three years.
No label is required with this application as the change only applies to a condition of label approval.
Application type
This application is considered under a technical variation (Item 14) as assessment is needed to demonstrate that the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria during the extended shelf life period.
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 1 month |
$902 |
|
2: Chemistry
|
A limited chemistry assessment is required to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria during the extended shelf life period. |
||
|
2.3 |
6 months |
$1 954 |
|
|
3: Toxicology |
No assessment required as the product is currently registered and relevant health standards are already established. |
||
|
4: Toxicology—Poison scheduling |
No assessment required if appropriate scheduling is already in place. |
||
|
5: Residues and trade |
No assessment required as there are no changes to product residue risks. |
||
|
6: Work health and safety |
No assessment required as the product is currently registered and the rate, method and timing of application is unchanged. |
||
|
7: Environment |
No assessment required as the product is currently registered and the rate, method and timing of application is unchanged. |
||
|
8: Efficacy and safety |
No assessment required as the registered product formulation and application are unchanged. |
||
|
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 does not contain approved antibiotic active constituent/s or genetically modified organisms. |
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|
11: Finalisation |
11.2 |
2 months |
$3 090 |
|
12: Limits on use (data protection) |
12.0 |
N/A |
$460 |
|
Total |
|
8 months |
$6 406 |