Applying for a label approval

Approval of multiple labels for a registered product

From 1 January 2015 a product can have multiple names.

The product will continue to have a distinguishing name recorded as part of the product registration, and this can still be used as the name for the product that appears on the product container label, as the marketed product label (MPL).

However, where you want to have a product known by a number of different names in the market, you can have multiple labels approved for your registered chemical products bearing different product names without having to apply for separate product registration. The distinguishing name and the product number will remain as the key identifiers for the product.

For products that are already registered, the distinguishing name that is currently registered will be the label name from 1 January 2015 until such time as it is varied.

Approval of a new label for your registered product

Once an agricultural or veterinary chemical product is registered, you can apply for a new label with a new name that is to appear on the label for containers for your product. This is a new type of application holders of agvet chemical product registration can make from 1 January 2015.

After your product is registered, where you want to:

add a new product name for use in the market
tailor the approved label particulars for marketing the product to a particular market segment (i.e. only include uses and instructions relevant to that market segment)

you can apply for a new label for your registered product so long as you are not varying the product, a use of the product, or any instructions related to a use of the product.

You can apply for a new label for your registered product without also requiring a variation to your product registration so long as you are not varying a use of the product, or any instructions related to a use of the product.

A separate application is required for each new label approval being sought.

This allows for your registered product to be supplied under a variety of names without having to apply for product registration of each individual name. Each product name that is to appear on the approved label must not be misleading, confusing or inconsistent with other label instructions or be easily confused with the names of other registered products.

Variations to labels

Variations that can be made to approved labels by way of notification to the Australian Pesticides and Veterinary Medicines Authority (APVMA) include:

the distinguishing name of a registered product
the name that is to appear on the label of a registered product
net contents where the net contents is within the range already approved for the product and the variation doesn’t result in a change to any instructions
instructions for use where the variation is to remove a use of the chemical product and does not affect any other instructions.

Other types of label variations, such as adding new instructions or modifying existing instructions can be made through a variation application.