This content is current only at the time of printing. This document was printed on 26 March 2019. A current copy is located at https://apvma.gov.au/node/1146
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What happens next
The APVMA will assess all applications for active constituent approval, product registration, label approval or variation in accordance with the APVMA legislation, and will complete that assessment within the applicable assessment period.
We will begin preliminary assessment of an application only after it has been lodged. The application is considered to be lodged when you provide the APVMA with the application information on the approved form accompanied by any other information as specified by the legislative instrument. You have seven days from when you submit the application, to submit any other information as specified by the legislative instrument. If, within this period, you do not submit the other information specified by the legislative instrument, you are taken to have lodged the application.
We will notify you that the application has been received within 10 days of it being lodged.
We will consider the use of the proposed active constituent, registration or variation (including any instructions for use or conditions) when determining whether use of an active constituent or chemical product and the associated label approval meets the safety criteria, trade criteria, efficacy criteria, or labelling criteria stipulated in the APVMA legislation.
The APVMA must issue an approval, registration or variation if we are satisfied that:
- the application meets the application requirements
- the constituent, product and label meet the safety criteria, trade criteria, efficacy criteria, or labelling criteria, as well as any matters prescribed in the Agvet Code Regulations.
Any amount payable to us must be paid before we can complete our evaluation.
The APVMA must refuse an application for approval, registration or variation if:
- the application does not meet the application requirements (this includes not meeting the requirements of an APVMA notice within the allocated timeframe or providing an inadequate response)
- in the case of a variation made under section 26B of the Agvet Code, the variation is not of a kind prescribed by regulation 19AF of the Agvet Code Regulations.
- in the case of a variation made under section 27 of the Agvet Code, the consent of the holder (when required) is not given, or
- it does not satisfy the statutory criteria listed above.