A variation to the registered pack size(s) constitutes a change to the relevant particulars of a registered product (the net contents being a relevant particular). The registered pack size(s) of a product can be varied via several pathways depending on whether the new pack size falls within the range currently registered.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) often receives notifiable variation (NV) applications for agricultural products requesting inclusion of additional pack sizes on a label. These NV applications would be unnecessary if the original registered pack size was specified as a range rather than discrete pack sizes. For example, a product approved in 5 L and 20 L containers would require an NV application to add a 10 L container to the label. Had the original pack size been specified as ‘5 to 20 L’ no NV application would be required.
This news item is a reminder to registrants for agricultural products that by specifying a packaging range for new products they could potentially avoid the need for subsequent NV applications. This does not apply to requests for additional packaging sizes outside an existing range which, depending on the circumstances, would be considered via an Item 12 or Item 14 application (see our tailored guidance for applicants for more information).~sAPVMA, 6 November 2020