Examples – Type 14 – Item 14 (Ag): Scenario 1

Scenario 1: Application to vary the excipients in the product formulation

Objective

A holder applies to vary the formulation of a registered fungicide to replace the approved formulation with a similar formulation. The proposed new formulation has the same active constituent, however the source of active is a greater purity (98 per cent compared to the previous 90 per cent), so less volume of the active constituent is required in the formulation to provide the label amount for the product. A number of excipients are also being changed.

Application type

This application is considered under a technical variation (Item 14) as assessment is required to demonstrate that the change in formulation will continue to satisfy the safety, efficacy and target crop safety criteria.

As the amount of active constituent in the formula is not changing, an updated label is not required to accompany the submission. There are no changes to scheduled solvents or surfactants so the first aid instruction and safety directions do not need to be changed.

Note: if during assessment it is identified that there is a change that requires a WHS assessment (for example, an increase in a solvent that is an eye irritant), additional modules would be applied.

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 Modules 2–10 for this variation.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

An assessment is required of the chemistry and manufacturing aspects of the new formulation to ensure the change in formulation does not change the physico-chemical properties of the product.

2.3

6 months

$1 954

3: Toxicology

No assessment required. The product is registered and the proposed changes do not affect the toxicology profile of the product.

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 residue risks associated with use of the product.

6: Work health and safety

No assessment would be required if there is no change to risks associated with product handling.

7: Environment

No assessment required as there is no change to environmental risk associated with the use of the product.

8: Efficacy and safety

An assessment is required in this situation as the changes to excipients may impact on efficacy or target crop safety.

8.3

3 months

$1 160

9: Non-food trade

No assessment required as minor formulation changes should not alter risks related to non-food trade.

10: Special data

No assessment required as neither the product nor the target crop contain any GMOs.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

 

8 months

$7 566

Heading: 
Examples