This content is current only at the time of printing. This document was printed on 31 March 2017. A current copy is located at http://apvma.gov.au/node/632
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A chemical product meets the labelling criteria if the label contains adequate instructions relating to the following as appropriate:
- the circumstances in which the product should be used
- how the product should be used
- the times when the product should be used
- the frequency of the use of the product
- the withholding period after the use of the product
- the re-entry period after the use of the product
- the disposal of the product when it is no longer required
- the disposal of containers of the product
- the safe handling of the product and first aid in the event of an accident caused by the handling of the product
- any matters prescribed by the Agvet Code Regulations, including:
- for a chemical product that is a veterinary chemical product, the duration of any treatment using the product
- the prevention of undue prejudice to trade or commerce between Australia and places outside Australia
- the appropriate signal words (if any) required by the current Poisons Standard
- for a chemical product that is a date-controlled chemical product, the storage of containers for the product
- any other matter determined by the CEO.
The APVMA must have regard to the following for the purposes of being satisfied whether a label meets the labelling criteria:
- any conditions to which its approval is, or would be, subject
- any relevant particulars and instructions that are, or would be, entered in the relevant APVMA file for the label
- whether the label conforms, or would conform, to any standard made for the label.
To grant an application, we must also be satisfied that you meet the application requirements, and have complied with any requirements made during the course of the evaluation.
An application meets the application requirements if :
- it is in writing in the approved form
- it is signed by the applicant
- it is accompanied by as much of the prescribed fee as is required to be paid when the application is made
- it is lodged with the APVMA
- it contains, or is accompanied by, any information specified by legislative instrument made by us under section 8B of the Agvet Code
- the constituent, product or label in relation to which the application is made complies, or will comply, with any requirement prescribed by the Regulations
- any requirement of you made by us under section 157 or 159 of the Agvet Code in relation to your application has been complied with;
- any requirement prescribed by another provision of the Code in relation to the application has been complied with; and
- any amount (including an amount in respect of a tax or penalty) that is payable by the applicant to the APVMA (including under a law of another jurisdiction or the agvet law) has been paid.