Pre-application assistance – timeframes and fees

Fees for pre-application assistance (PAA) are charged on a per-unit basis based on the complexity of the request and the effort required. The Legislative Instrument made by the Australian Pesticides and Veterinary Medicines Authority (APVMA) under regulation 69B of the Agvet Code sets out the criteria for working out which PAA fee applies under the Agricultural and Veterinary Chemicals Code Regulations 1995.

Tier 1 and 2 timeframes and fees

An admin fee of $192.50 is included in the total price for tier 1 and tier 2 PAAs.

PAA tier

Timeframe

Components

Total fee (incl GST)

Tier 1

1 month

Written response only

$577.50

2 months

Written response + meeting

$962.50

Tier 2

2 months

Written response only

$962.50

2 months

Written response + meeting

$1 347.50

Tier 3 timeframes and fees

Tier 3 timeframes and fees are variable dependent on the number of trial protocols to be appraised and whether or not a project plan and/ or meeting are included.

Applications with multiple protocols will be charged a fee of $1155 for the appraisal of each protocol.

PAA tier

Timeframe

Components

Fee per component (incl GST)

Tier 3 – variable fees

3 months

Admin – mandatory

$192.50

Appraisal 1 x protocol *

$1 155.00

Project plan (required for all timeshift applications and Global Joint Reviews)

$1 155.00

Meeting (optional)

$385.00

* Module types are set out in Schedule 7 of the Agricultural and Veterinary Chemicals Code Regulations 1995.

More information on the 3 tiers of PAA is available on our website.

When are fees paid?

Fees are paid at the time the PAA application is made through online services.

Rebates and refunds

In some circumstances, if any PAA fee was paid in relation to a proposed product application your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

When you apply for approval, registration or variation, you will be able to include the unique reference number given to your request for PAA. This number will indicate to the APVMA that you received PAA and will allow us to reduce the application fee appropriately, as well as retrieve the record of any assistance we provided to inform our consideration of the application.

If you provide the full application fee with your application, we will remit the applicable amount of the PAA fee as set out in the table of fees and assessment periods before the application is determined.

If you only provide the minimum assessment fee with your application, we will reduce the balance of the outstanding fee by the amount of PAA fee, as per the table of fees and assessment periods, when we request the balance of the fee.

No rebate is applicable for a request for PAA made in relation to an application for technical assessment, manufacturing license or registration renewal.

Related information

For further information on how PAA fees are calculated and applied, refer to the Legislative Instrument.

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