Scenario 1: Variation to the in-use shelf life of a registered veterinary product (e-label required)
Objective
Application is made to extend the in-use shelf life (ie the shelf life of the product after first broaching the container) of an injectable antibiotic from seven to 28 days.
The applicant has undertaken in-use stability trials demonstrating that the product continues to meet the product specifications for up to 28 days after broaching.
Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the proposed new shelf life for the product does not impact the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.
An updated label reflecting the change in storage details must be included in the application.
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. Considerations are necessary for this extension for Modules 2–10.
|
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 ensure that changes to the product shelf life particulars will not change the safety, efficacy or trade related aspects of the currently considered specifications for the product. |
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|
2.3 |
6 months |
$1 954 |
|
|
3: Toxicology |
No assessment required as the product is currently registered and relevant health standards are already established and there are no changes to the use pattern. |
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|
4: Toxicology—Poison scheduling |
No assessment required as appropriate scheduling is already in place. |
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|
5: Residues and trade |
No assessment required as there are no changes to product residue risks. |
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|
6: Work health and safety |
No assessment required as the product is currently registered and the rate, method and timing of application/administration is unchanged. |
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|
7: Environment |
No assessment required as the product is currently registered and the rate, method and timing of application/administration is unchanged. |
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|
8: Efficacy and safety |
No assessment required as the registered product formulation and use pattern are unchanged. |
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|
9: Non-food trade |
No assessment required as there are no changes to product risks to non-food trade. |
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|
10: Special data |
No assessment required as there is no change in risk from the in-use shelf life extension. |
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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 |