Other Regulated Fees and Fees for Discretionary Services

APPLICATION TYPES

Fees

(incl. GST)

Approvals

Waiver of notification

(Section 15 of ACVM Act)

$149.60/hr

Meetings/enquiries regarding ACVM Applications

Information Waivers

(Section 10 of ACVM Act)

$149.60/hr

Individual reports for reporting from ACVM Database

$149.60/hr

Compliance

Monitoring compliance with trade name product conditions or regulations

$149.60/hr

Inspections for enforcement

$149.60/hr

Official Information requests

First half hour

No charge

Every half hour thereafter

Copy charged (after the first 20pages) is in addition to the hourly charge

$74.80

$0.20/page

Approved Operating Plans

(section 28 ACVM Act)

$149.60/hr

APPLICATION TYPES

Fees

(incl. GST)

Certificates

Certificates of Free Sale

Certificate of Origin for Pharmaceutical Veterinary Products

Good Manufacturing Practice Certificate

$149.60/hr + $149.60/hr

Additional certificate copies

NB: Must be on the same written request

1-10 copies $11.25

11-20 copies 2x $11.25

21-30 copies 3x $11.25 etc…

Class Determinations

One application

Assessing duplicate application of product which has had previous class determination¹

$149.60/hr

$149.60/hr

Additional certificate copies

NB: Must be on the same written request

$11.25

Two or more applications together

$149.60/hr + $149.60/hr

Additional copies of the determination requested

1-10 copies $11.25

11-20 copies $11.25 etc…

Data Assessment Service (DAS)

Initial screening fee

During the DAS, the ACVM Group will track actual time and invoice at regular intervals.

$299.20

$149.60/hr (per hour)

Information Waivers

Base fee

If data volumes require assessment, then a charge of cost versus time basis will apply, plus any disbursement costs. These charges will be invoiced separately. An estimate of time to be taken for the evaluation will be given, prior to commencement of the evaluation.

$545.62

$149.60/hr (per hour)

Import Approvals

Special Use

Repacking/relabelling of a registered product

Re-export

Analysis only

Use in quarantine

Veterinary discretionary use

$149.60/hr

Premises Inspections

Fees for HGP distributor Inspection

$149.60/hr plus disbursements (e.g. travel, courier)

GMP Inspections

$149.60/hr plus disbursements (e.g. travel, courier)

Other Discretionary Services

Fees for setting Maximum Residue Limits (MRL)

$149.60/hr plus disbursements (e.g. travel, courier)

Meetings with parties on request

NB: Where not regarding a trade name product, e.g.; general queries

$149.60/hr

Photocopying information

$0.20/page + $149.60/hr time taken