Scenario 1: Change in product formulation involving a new solvent that changes the viscosity of a pour-on product
Objective
An application is made to vary the formulation of a registered pour-on parasiticide for use in food producing animals (cattle and sheep) to substitute one solvent for another.
The new solvent is a major component of the formulation (90%). The change will alter the viscosity of the product.
The applicant sought pre-application assistance because of the significant change and was advised that the new solvent has some minor health risks to humans and may require changes to the label instructions for use, re-handling and first aid. Residues assessment will also be required to assess if a change to the withholding periods is necessary.
Target animal efficacy and safety studies are also required to demonstrate comparable efficacy 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 change in formulation will not affect the product’s capacity to meet the statutory criteria.
As the formulation change will result in changes to the label (safety directions and first aid instructions), an updated label 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 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 |
An assessment is required to establish the toxicological profile of the new formulation. |
||
|
3.3 |
5 months |
$4 050 |
|
|
4: Toxicology—Poison scheduling |
No assessment required if appropriate scheduling is already in place. |
||
|
5: Residues and trade |
An assessment is required as the change to the product formulation is expected to alter residue risks and requires an assessment of withholding periods or MRLs. |
||
|
5.4 |
4 months |
$7 465 |
|
|
6: Work health and safety |
An assessment is required to establish new safety directions and precautionary statements. |
||
|
6.3 |
4 months |
$3 913 |
|
|
7: Environment |
No assessment required as there is no change to environmental risk. |
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|
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 as formulation change does not alter risks related to non-food trade. |
||
|
10: Special data |
No assessment required as this product is not an antibiotic or GMO. |
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|
11: Finalisation |
11.1 |
3 months |
$8 110 |
|
12: Limits on use (data protection) |
12 |
N/A |
$460 |
|
Total |
|
9 months |
$28 014 |