This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/26671
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The APVMA reviews and approves the text on the e-label form submitted with a product application. This text is published as the ‘approved label’ for the purposes of registration.
This text is also referred to as the relevant label particulars in relation to the approval of a label. The APVMA approves the relevant label particulars only and no longer approve the marketed product label.
Using the e-label form
Applicants need to provide the relevant label particulars via a separate e-label form in Online services. Applicants need to read the labelling codes for comprehensive instructions on preparing their instructions for use and label particulars.
How to complete an e-label form
- click on the ‘e-label (vet)’ or ‘e-label (ag)’ item in the left menu bar when logged-in to Online services
- use the same decision ID as used in the application for the product or to link the e-label to the application
- if you are varying a label and have not previously completed an e-label form online, you will need to complete all sections of the label
- if varying a label that has previously been completed online, you only need to select and complete the sections of the label that require changing.
Submit the e-label application before submitting the related product application—you will not be able to submit the primary application until the e-label application is completed.
When completing an e-label application for the first time, all sections relevant to your product should be completed. You are able to preview a copy of the label particulars you have entered at any time by clicking the draft button in the top right-hand corner of each tab. More information about what your label should include is available from:
- label content—agricultural products
- preparing a label and the label approval process—agricultural
- label content—veterinary products
- preparing a label and the label approval process—veterinary.
A comment box is available on each page of the e-label form. Use this to provide comments for consideration by APVMA.
E-label approval process
Once your e-label is submitted it will be reviewed as part of the evaluation process. We will include any required changes or information in the comment field of your e-label application and notify you that action is required. Your application will then be listed under the ‘For action’ tab within your e-label application. A copy of your approved label will be sent to you with your notice, once your application has been approved.