Schedule of Estimated Fees for the Regulatory Assessment of Plant Compounds (including GST)

Application Types

Description of Type

Pre-screen fee (Section 10 of ACVM Act)

Processing time

(Regulatory timelines as set In the ACVM Act)

Note: If there is a significant new risk profile or change in the risk profile, an additional 30 working days will apply for public consultation

Estimate of Fees

(These fees are an estimate of actual time versus cost as per the Fee Regulations. Disbursements relating to the application are also payable by the applicant and are not covered in these estimates) The hourly rate is charged out at $149.60/hour (inc. GST)

New Applications

A1

New Active Ingredient

$545.62

40 working days

$1683.00

A2

Existing Active Ingredient with Different profile e.g. new use

$545.62

40 working days

$1683.00

B1

Identical to Registered Products

(Refer to Smart Track Guidelines)

40 working days

$598.50

B2

Similar to registered product i.e. same active ingredient, same formulation type, same dose regime, same use patterns

$545.62

40 working days

$1683.00

B3

Specified Requirements Product

40 working days

$710.60

B3 Variations

For Specified Requirements Product variation applications the fee of $710.60 will apply. For administrative variations the C9 fee will apply.

40 working days (if there is a significant new risk profile, an additional 30 working days will apply for public consultation + costs for public consultation time & gazetting)

$710.60

Variation Applications

C1

Change in Formulation

$545.62

40 working days

$860.20

C2

Change in Manufacturing Process;

Change in Site of Manufacturer or Technical Active Ingredient;

New or Additional Manufacturer;

$545.62

40 working days

$822.80

C3

Change in Shelf Life, Storage or Packaging Specifications

Change in Packaging Specifications (only)

$545.62

40 working days

$822.80

C4

Additional Target Host

$545.62

40 working days

$1346.40

C5

Additional Pest/Weed/Disease

$545.62

40 working days

$1346.40

C6

Change in Application Rate/Timing

$545.62

40 working days

$1346.40

C7

Change in Method of Application

$545.62

40 working days

$1346.40

C8

Change in Withholding Period

$545.62

40 working days

$1346.40

C9

Change in Name/Address of Manufacturer;

Change in Label Text or Layout;

Change in Trade Name;

Change in Address of Registrant;

Transfer of Registrant;

40 working days

(ACVM expected processing time = 15 working days)

$526.30

Provisional Registration

Provisional Registration

To carry out trial work with a trade name product (end use formulation) in order to obtain further data to support registration.

40 working days

$860.20

Variation to Provisional Registration

To vary the terms and conditions of a Provisional Registration.

40 working days

$822.80

Research Approval

Research Approval

To enable the use of a substance for research that is not characterised as a trade name product.

40 working days

(Non-Regulatory)

$860.20

Variation to Research Approval

To vary the terms and conditions of a Research Approval.

40 working days

(Non-Regulatory)

$822.80

Smart Track

C1 – C8

Variation applications that require registration renewal

$523.70

C1 – C8

Variation applications that do not require registration renewal

$374.10

Registration Renewals

Plant Compound Registration Renewals

As at 1 July 2008 Registration Renewals are now charged out at cost verses time based on the hourly rate $149.60/hour (Incl. GST)

Annual Fees

Plant Compound Annual Fees

$545.62