Scenario 3: Change in product formulation of an immuno-biological product
Objective
An application is made to change the proportions of excipients in a live attenuated viral vaccine product for use in dogs. No constituents are to be removed or new ones introduced, only the relative proportions of the non-active constituents are to be varied. Stability and in-use stability data have been included in the chemistry submission, and data have been generated using the varied formulation to demonstrate comparable efficacy and animal safety with the previously approved formulation.
Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the formulation variation will not affect the product’s capacity to satisfy the statutory criteria.
No change to the label is required.
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 variation. 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
|
An assessment is required to ensure the proposed formulation changes are acceptable. |
||
|
2.3 |
6 months |
$1 954 |
|
|
3: Toxicology
|
No assessment is required as the product is currently registered and the proposed variation is not expected to impact on the toxicological profile of the product. |
||
|
4: Toxicology—Poison scheduling
|
No assessment required as there are no changes to the scheduling of the constituent. |
||
|
5: Residues and trade |
No assessment required as the formulation change will not alter the previous assessment of risks to residue and trade. |
||
|
6: Work health and safety |
An assessment is not required as the product is currently registered and the rate and method of application are unchanged. |
||
|
7: Environment
|
No assessment required as there is no change to environmental risk. |
||
|
8: Efficacy and safety |
An assessment is required to ensure changes to product formulation do not affect target animal safety and the efficacy of the product. |
||
|
8.3 |
3 months |
$1 160 |
|
|
9: Non-food trade |
No assessment required. |
||
|
10: Special data
|
No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms. |
||
|
11: Finalisation |
11.2 |
2 months |
$3 090 |
|
12: Limits on use (data protection) |
12 |
N/A |
$460 |
|
Total |
|
8 months |
$7 566 |