This content is current only at the time of printing. This document was printed on 18 September 2020. A current copy is located at http://www.xlg888.com/node/506
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We will complete a preliminary assessment of an application within one month of the application being lodged to determine if it appears to meet the application requirements. The application requirements as defined by the legislation require it to be:
- in writing, in the approved form and signed by the applicant
- accompanied by the relevant fee (refer to application fees and timeframes)
- accompanied by any information that is specified in the legislative instrument.
The preliminary assessment is not a technical assessment to determine if we are satisfied that the application meets the safety criteria, efficacy criteria, trade criteria or labelling criteria; nor will a decision be made in relation to the accuracy of the level of assessment that has been identified as being required to determine your application. The APVMA must refuse applications at preliminary assessment if they do not meet the application requirements. ?
You will be notified of the outcome of preliminary assessment within 14 days of the decision being made. If the application is refused, you will receive a notice that will include the reasons for the refusal.
Applications that pass preliminary assessment—advice to applicants
If the application appears to meet the application requirements, you will receive a notice that includes:
- advice that the application has passed preliminary assessment and will be determined under section?14 of the Agvet Code, or that it has passed preliminary assessment and will be determined under section?29 of the Agvet Code
- the date on which the assessment of the application will commence
- the balance of the application fee payable (if any) which must be paid within 28?days of the date of the notice
- advice that we may determine that the application is more correctly categorised as a different item in Part?2 of Schedule?6 to the Agvet Code Regulations than the item for which any fee has been paid, or that a different module level mentioned in Schedule?7 to the Agvet Code Regulations is necessary. A further amount of application fee may be payable or refunded and the assessment period of your application may change
- the number of copies (if any) of the application you must give to the APVMA, within 28?days of the date of the notice and in the required format
- the assessment period for the application and the expected date by which the application will be determined
- the modules (if any) that apply to the application
- advice that if we make a request for specific information under section?159 of the Agvet Code, the assessment period will be extended
- nominated agents’ obligations (for applications made by nominated agents)
- your obligations regarding relevant information that contradicts previous information given to us or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria
- advice that if we do not determine the application within the assessment period (and any extension to the assessment period), you may notify us that you wish to treat the application as having been refused, and may seek review of the refusal
- a reminder that you may withdraw your application at any time before it is determined, by giving us a signed, written notice
- that if the balance of fees or additional copies of your application are requested, the assessment period will commence on the day the notice is complied with, within the allowable 28-day period, and that the application will be refused if the notice is not complied with within the 28-day period.
After an application passes preliminary assessment we may alter it with written consent of the applicant—for example, to correct typographical errors or in conjunction with a Notice of Proposal to Refuse or approve or register an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application which is issued to you. We cannot be compelled to amend an application and will only do this where it is efficient to do so.
An application to vary prescribed particulars or conditions made under section?26B of the Agvet Code is not subject to a preliminary assessment. After the application is lodged, we will determine it under section?26C of the Agvet Code.