Pre-application assistance— timeframes and fees

The fees for pre-application assistance are charged on a per-unit basis based on the complexity of the request and the effort required. The Legislative Instrument made by the APVMA under regulation 69B of the Agvet Code Regulations sets out that $192.50 constitutes one unit of pre-application assistance.

Under the new simplified arrangements for pre-application assistance there is a flat fee for each level of assistance:

Tier 1:    $577.50
Tier 2:    $962.50
Tier 3:    $1347.50 + $1155 per additional module chosen

An additional flat fee of $385 is payable if a meeting is requested.

Table of fees and timeframes

PAA tier/timeframe

Type of assistance

Fee (incl GST)

Fee examples

Tier 1

1 month - written response

2 months  - meeting

Administration

1 unit ($192.50)

Written response

$577.50 (1 unit admin + 2 units research and preparation)

Including meeting

$962.50  (1 unit admin, 2 units research, 2 units meeting)

Research and preparation

2 units ($385)

Meeting (optional)

2 units ($385)

Tier 2

2 months

Written response or meeting

Administration

1 unit ($192.50)

Written response

$962.50 (1 unit admin + 4 units research and preparation)

Including meeting

$1347.50  (1 unit admin, 4 units research, 2 units meeting)

Research and preparation

4 units ($770)

Meeting (optional)

2 units ($385)

Tier 3

3 months

Written response or meeting

Administration

1 unit ($192.50)

Appraisal 1 x protocol

$1347.50 (1 unit admin, 6 units 1 x module)

Appraisal 2 x protocols including meeting

$2887.50 (1 unit admin, 12 units 2 x modules, 2 units meeting)

 

1 x project plan incl. meeting

$1732.50 (1 unit admin, 6 units 1 x project plan, 2 units meeting)

Research and preparation

6 units/per module* ($1155)

Or

6 units for project plan

Meeting (optional)

2 units ($385)

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

When are fees paid?

Fees are paid at the time the pre-application assistance application is made through online services.

Rebates and refunds

In some circumstances, if any pre-application assistance 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 an approval, registration or variation, you will be able to include the unique reference number given to your request for pre-application assistance. This number will indicate to the APVMA that you received pre-application assistance 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 pre-application assistance 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 pre-application assistance 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 pre-application assistance made in relation to an application for technical assessment, manufacturing license or registration renewal.

Related information

For further information on how pre-application assistance fees are calculated and applied, refer to the Legislative instrument.

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