Scenario 2: Change in product formulation resulting in a change to physico-chemical properties
Objective
An application is made to vary the formulation of a horse parasiticide paste product. The amount of humectant in the formulation has been increased and exceeds one percent of the product 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 stability of the product. The application includes a chemistry data package.
No change to the product 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 is required. |
||
|
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 |
No assessment is required as the proposed change is not expected to alter the safety or efficacy of the product. |
||
|
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 |
11.3 |
2 months |
$3 090 |
|
12: Limits on use (data protection) |
12 |
N/A |
$460 |
|
Total |
|
8 month |
$6 406 |