This content is current only at the time of printing. This document was printed on 25 June 2021. A current copy is located at http://www.plural-consulting.com/node/869
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Requiring additional information
For the purpose of determining an application in relation to an active constituent, chemical product, label or permit, the APVMA may seek correction or clarification of the information provided with the application under section 159 of the Agvet Code. You may be required to take one or more of the following actions:
- give the APVMA information of a kind stated in a written notice, for example:
- information to support what has already been provided;for example, where reference is made to additional studies or information which has not been provided; or where the information provided is incomplete
- information to correct an error in the application—for example, where every second page is missing from a document, or a document listed on the data list has not been provided
- carry out a search of published literature for information about the active constituent, ?chemical product or any of its constituents, and give a report to the APVMA on the results of that search.
- give a sample of the active constituent, or of the chemical product or any of its constituents, to the APVMA, or to another body determined by the APVMA or authority, in order for it to be analysed by an approved analyst.
Our power to require additional information relates to the provision of information that is already in existence so does not extend to requiring the generation of data.
If we require clarification of the information submitted with the application, we will issue a notice under section 159 of the Agvet Code requesting this.
When we issue a notice of this kind, the assessment period for the application will be extended when the first notice is issued. The notice will specify the period in which a response must be provided. If a response is not received before the end of the period set out in the notice, a Notice of Proposal to Refuse Application will be issued and all further evaluation of the application will put on hold until the period stated in the notice expires. If the outcome is to refuse the application, no further evaluation will be conducted prior to the refusal.
The Agvet Code Regulations use the following formula to prescribe the maximum period which can be included in this notice:
MP = XP - 1 month
MP means the maximum period
XP means the extended assessment period mentioned for the application in column 3 of Part 2 of Schedule 6 of the Agvet Code Regulations minus the assessment period mentioned for the application in column 2 of Part 2 of Schedule 6 of the Agvet Code Regulations.
For example, if the assessment period for an application is three months, and the extended assessment period is five months (XP=5-3), then the maximum amount of time you have to respond to a notice requiring further information is one month (MP=2-1).
We may allow a further period if an extraordinary event or circumstance beyond your control prevents you from complying with the period stated in the notice. For a time shift application, the maximum period is the period agreed to by the APVMA and the applicant.