This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/667
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Timeframe and fees
The assessment period for a new permit application commences on the day:
- the notice advising you that your application has passed preliminary assessment is issued, provided you are not required to provide copies or your application or pay an outstanding amount of fees or
- you comply with the notice requesting the balance of fees or additional copies of your application.
The assessment period for a permit extension commences on the day we issue you with a notice advising you that your application for a permit extension will be assessed under subsection 115 is issued.
As soon as practical after the commencement of the assessment period, we aim to determine:
- if your application should be recategorised to ensure that the item and level of module assessment originally identified is appropriate
- if argument provided in your application in lieu of data is appropriate
- if there are any obvious and critical information gaps in the dossier.
The assessment period may change if one of the circumstances listed below applies to the application:
- if a notice requiring specified information under section 159 of the Agvet Code is issued, the extended assessment period prescribed by the Agvet Code Regulations will apply. This extension can only be applied once, regardless of how many notices are issued under section 159.
- if a notice is issued changing the item or module, level or type that is required to determine your application and this results in a change to the assessment period or fees, the assessment period may be lengthened or shortened. Where you are required to pay an additional fee the assessment period will be extended to allow for the period until the fee is paid. Fees must be paid within 28 days from the date of notice
- if a Notice of Proposal to refuse is issued to you the assessment period will be paused for the 28-day period within which you are invited to respond to the notice.
Assessment periods and fees
The application fee and the assessment period in which the APVMA is required to determine an application vary depending on the complexity of the application.
|Item||Description of application||Assessment period||Fee
1 July 2014
1 Jan 2015
|Maximum pre‑application assistance rebate|
|19||A permit, or extension of a permit, to possess or supply, other than for use in Australia, an active constituent that is not an approved active constituent or a chemical product that is not a registered chemical product, where no data of a technical nature is required||3 months||$350||$350||$350|
|20||A permit, or extension of a permit, where a previous assessment remains valid and no data of a technical nature is required||3 months||$350||$350||$350|
|21||A permit, or extension of a permit, where the proposed use is a minor use||Modular assessment period||$350||$350||$350|
|22||A permit, or extension of a permit, in respect of a chemical product or an active constituent if the proposed use of the chemical product or active constituent is determined by the APVMA to be an emergency use||Nil||Nil|
|23||A permit, or extension of a permit, in respect of a chemical product or an active constituent if the application is not of a kind described in any of items 19 to 21||Modular assessment period and fee||$350|
|Module level||Module type||Period for completion||Fee
1 July 2014
1 Jan 2015
|1||Preliminary assessment||Not applicable||$620||$710|
|2.5||Chemistry—timeshift only||As set out in project plan||$8065||$9220|
|3.4||Toxicology—timeshift only||As set out in project plan||$24,430||$27,920|
|4.1||Toxicology requiring poison schedule classification||13 months||$2435||$2435|
|4.2||Toxicology requiring poison schedule classification—timeshift only||As set out in project plan||$2435||$2435|
|5.3||Residues (permit only)||8 months||$7175||$8200|
|5.5||Residues (permit only)||4 months||$1750||$2000|
|5.6||Residues—timeshift only||As set out in project plan||$15,900||$18,170|
|6.1||Occupational health and safety||13 months||$4310||$4410|
|6.2||Occupational health and safety||7 months||$2900||$3185|
|6.3||Occupational health and safety||4 months||$3480||$29101|
|6.4||Occupational health and safety—timeshift only||As set out in project plan||$4310||$4410|
|7.4||Environment—timeshift only||As set out in project plan||$23,095||$26,390|
|8.1||Efficacy and safety||6 months||$2075||$2370|
|8.2||Efficacy and safety||4 months||$855||$975|
|8.3||Efficacy and safety||3 months||$505||$580|
|8.4||Efficacy and safety—timeshift only||As set out in project plan||$2075||$2370|
|9||Non-food trade||6 months||$1175||$1175|
|10.1||Special data||13 months||nil||nil|
|10.2||Special data||7 months||nil||nil|
|10.3||Special data||7 months||nil||nil|
|10.4||Special data—timeshift only||As set out in project plan||nil||nil|
|12||Data protection||Not applicable||$400||$460|
1Per the Agvet Regulations Schedule 7, the fee for module 6.3 is $3980. However the APVMA has waived a portion of this fee to bring it in proportion to the fees charged for modules 6.1 and 6.2. $1 070 of the $3980 fee has been waived to bring the fee down to $2910.