This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/332
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Applications for approval or registration, and for variation of relevant particular or conditions of approval or registration, must be complete and contain all relevant information. In particular, it must contain information in relation to the statutory criteria the APVMA is required to be satisfied of in determining the application (such as the safety criteria, the efficacy criteria or the trade criteria). If you intend to refer to a reference product (that is, a registered chemical product) from which the APVMA can draw some or all of its satisfaction of the relevant criteria, you must provide consent for the use of any confidential commercial information (CCI) associated with the reference product.
We will not search our information archives to retrieve information we hold—whether its use is limited or not—to support applications. If you wish to rely on information to address particular statutory criteria, rather than referencing a use for some other element of satisfaction of the criteria from a reference product, you will need to provide all relevant information with the application.
If you are submitting information to support your application, you are required to provide a data list with the application (see below).
If you are making an application that is reliant on a reference product, before lodging the application you should first check whether the information associated with that reference product is subject to the limits on use of information provisions in Division 4A of Part 2 of the Agvet Code. This can be done via our public database. If limits on use do apply, you will need to arrange for the authorising party to give you written consent to the use of the information prior to lodging the application. Evidence of such consent must be provided with the application.
If any of the information relating to the reference product might be CCI and the APVMA needs to access this in order to progress your application, you need to obtain consent of the authorising party. Evidence of such consent must be provided with the application.
The consent from the authorising party must be in writing, must identify the information in question and must expressly allow for the disclosure to and use of the information by the APVMA. The consent should also specify any limitations that apply to the consent. For instance, the authorising party may agree to allow the use and disclosure of the information to the APVMA, to the extent that it is necessary to determine the application in question, but not to the applicant.