Item 7 applications and pack size changes

2021-09-20

Applications to register a new agricultural product, based on that product being closely similar to a reference product, can have additional pack sizes providing that no data are required to support the pack size.

For example, the reference product has the following approved pack sizes: 10 kg, 20 kg and 110 kg. Your proposed product meets the definition of ‘closely similar’ but you wish to add a 100 kg and 1,000 kg pack size, which are not approved on the reference product.

As no data are required to support the additional pack sizes, the formulation is closely similar to the reference product and the label instructions are the same as the reference product, this example application would meet the criteria of an Item 7 application.

These applications should not be submitted as an Item 10 with only a preliminary assessment (Module 1) and finalisation (Module 11.2) module with a 2-month timeframe. Applications of this nature will be re-categorised to an Item 7.

More information about the benefits of requesting pack size ranges rather than individual pack sizes is available on our website.

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~sAPVMA, 20 September 2021

https://apvma.gov.au/node/91481