This content is current only at the time of printing. This document was printed on 19 September 2020. A current copy is located at http://www.xlg888.com/taxonomy/term/17956
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I want an additional marketing name for my existing registered product
A registered chemical product can be marketed under more than one product name. The approval of an additional marketing name is processed as an Item 10A. There is no technical assessment and no data is required. This application type can only be submitted by the holder of the existing product.
- An Item 10A application is for an approval of an additional marketing label for a registered product.
- It is not a new product registration (repack) or a label variation.
- It will not get a new product number.
The new label must be identical to the current label for the registered product apart from the following exceptions:
- The registered product name can be replaced with the additional marketing name.
- The label claims and instructions for use may be a subset of those on the approved label, such as a subset of the crops, animals treated and/or target pests.
The label on the existing registered chemical product should be up to date and comply with the current labelling criteria. It is worthwhile checking the label contents, including a comparison with the First aid instructions and safety directions handbook to ensure the existing label is up to date.
If you wish to apply for more than one additional marketing name you will need to lodge a separate application for each additional marketing name.
Which application form do you need?
Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.
A registered chemical product can be marketed under more than one brand name. An application can be made for the approval of a label for a container for a registered chemical product under Schedule 6 Part 2 Item 10A of the Agvet Code Regulations.
To approve a label the APVMA must be satisfied of the relevant matters in s 14 (1) of the Agvet Code. The APVMA must also be satisfied that the additional marketing label meets the s5D labelling criteria.
The application needs to meet the application requirements as defined at s 8A of the Agvet Code. The application must contain, or be accompanied by, information specified for this type of application as set out in Part 3 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
Timeframe and fees
Timeframe and fees
This application is considered under Item 10A and is subject to the following modules.
|Module level||Module type||Timeframe||Fee|
|1.0||Preliminary assessment||Not applicable||$902|
|11.3||Finalisation||2 months||$1 730|
|Total||?||2 months||$2 632|
This application type is subject to an extended assessment period if additional information is required. In these circumstances, the maximum extended assessment period for 10A applications is four months.
What you need to provide
To meet the application requirements you will need to provide:
- a completed online application form
- the application fee plus any amount that is due to the APVMA
- nominated agent (if applicable)
- an electronic label (e-label).
Completed online application form
If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.
Nomination of an authorised agent
If you are not a resident of, and do not carry on business in, Australia, you will already have a nominated agent attached to your existing product. In most cases an Item 10A is submitted by this nominated agent but it is possible for an authorised agent to submit the application on behalf of the nominated agent.
The application fee
You may choose to either:
- pay the total fee of $2632 when you submit your application, or
- pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has passed preliminary assessment.
You can pay by credit card, BPay or electronic funds transfer from within the application form in online services.
Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).
Electronic label (e-label)
An e-label must be provided that is identical to the original approved label apart from the following exceptions:
- the registered product name can be replaced with the additional marketing name wherever it occurs on the label
- it may contain a subset of the claims and instructions for use from the approved label, such as a subset of the crops, the animals treated and/or the target pests on the existing product’s label.
When choosing the additional name for your product you should check it is not already used for an existing product. The use of superlatives beyond those in the existing name should not be used.
ABC Agvet Chemicals currently has a registered product named ABC Fleekilla (APVMA product number: xyzjlk) for the control of fleas on dogs and cats. ABC Agvet Chemicals wishes to also market the product as ABC FleeOff for control of fleas on cats. ABC Agvet Chemicals applies for approval of a label under Item 10A and submits the additional label which is the same as the existing label except the name is different (FleeOff) and the claims and instructions only include the sections about cats. This application will be assessed under Item 10A.
Start an application
If you want an additional marketing name for your existing registered product (Item 10A):
You will be redirected to online services to log in.