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Fees & Charges for Applications

On 1 September 1999, the new registration information packages and standards came into effect. All applications now being submitted to the ACVM Group must comply with the information requirements specified in these packages. The module fee structure set out in the current Animal Remedy (Fees) and Pesticides (Fees) Regulations 1997, effective 15 January 1998, will stay in force to cover the new types of applications set out in the new packages. During the development of the new registration information packages it became apparent that certain types of applications were not accurately reflecting processing costs. It was agreed at the recent Animal Remedies and Pesticides Decision-Making Committee meeting that fees for the following application types be partially waived:

ANIMAL REMEDIES

Minor formulation change
The administrative fee has been partially waived to $546.75 (incl. GST). However, when a formulation change is made that requires more than just the chemistry and manufacturing volumes and impacts on the risk profile, then the application will be treated as a Major Formulation Change and the administrative fee of $2095.88 (incl. GST) will be charged.

Change in Shelf life or Packaging Specifications
This type of application now only requires the chemistry volume (which includes stability to be assessed). Therefore the chemistry data volume fee has been partially waived to $227.81 (incl. GST).

Change in Packaging Specifications Only
Where the change in packaging specifications does not change the shelf life or affect the stability data held on that file, then the fee of $364.50 (incl. GST) will be charged.

Provisional Registration
The new provisional standard has now combined Provisional Class I and II licences into a single provisional licence and discontinued Provisional Class III. Therefore the administrative fee of $546.75 (incl. GST) will be charged for this type of application.

PESTICIDES

Minor Formulation Change
Applicants are now required to provide packaging details, shelf life data and manufacturing and quality control data for this application type; therefore the administrative fee has been set at $546.75 (incl. GST). However, when a formulation change is made that requires more than just the chemistry and manufacturing volumes and impacts on the risk profile, then the application will be treated as a Major Formulation Change and the administrative fee of $2095.88 (incl. GST) will be charged.

Change in Shelf life or Packaging Specifications
Change in Manufacturing Process
Pesticide applicants are now required to apply to the Board for these types of applications. Therefore the administrative fee of $546.75 (incl. GST) has been set for these types.

Change in Packaging Specifications Only
Where the change in packaging specifications does not change the shelf life or affect the stability data held on that file, then the fee of $364.50 (incl. GST) will be charged.

Provisional Registration
The new provisional standard has combined Experimental Use Permits (Not for Sale) and (Limited Sale) into a single provisional registration. The administrative fee of $364.50 (incl. GST) will be charged plus an additional fee to process a food approval if the applicant wishes to sell the produce.

Pre-screening
Please remember that the pre-screen fee $364.50 (incl. GST) must accompany all applications, except for C9 Administration application types.

The new fees associated with their types of applications will soon be available on our website under ‘Publications/ Information Require-ments’. For any enquiries on the fees please contract Jodie Trubshoe (phone: 04 474 4157 or e-mail: trubshoej@maf.govt.nz).