I want an additional marketing name for my existing registered agricultural product

1. Legislation

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.

2. Timeframe and fees

This application is considered under Item 10A and is subject to the following modules.

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.

3. 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).

3.1. 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).

3.2. 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.

3.3. 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.

3.4. Completed online application form

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

4. Examples

4.1. Scenario 1

XYZ Agvet Chemicals currently has a registered product named Fungi-Go fungicide (APVMA product number: xyzjlk) for the control of fungus on citrus and stone fruit trees. XYZ Agvet Chemicals wishes to also market the product as No More Citrus Spots fungicide for use on citrus trees only. XYZ Agvet Chemicals applies for the 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 and the claims and instructions only refer to citrus trees. This application for a label will be evaluated under Item 10A.

5. Start an application

If you want an additional marketing name for your existing registered product (Item 10A):

Start application

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