This content is current only at the time of printing. This document was printed on 15 December 2019. A current copy is located at https://apvma.gov.au/node/20281
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Expanded list of notifiable variations
Five new items have been added to the list of notifiable variations for active constituents, products and labels, as an outcome of the APVMA’s lower regulatory approaches to registration project.
Notifiable variations are changes to active constituents, products and labels that do not require an application to be submitted to the APVMA. Instead, they are submitted through a simpler and faster process of notification.
The new items include:
- the site address at which the approved active constituent is manufactured by the manufacturer, provided there is no physical change of location
- the name of any other registered products referred to within the instructions for use on the label, provided the referred to product has the same APVMA approval number
- instructions for storage and disposal of containers of products in line with the relevant requirements for that type of container as specified in the Agricultural Labelling Code or Veterinary Labelling Code
- safety directions and first aid instructions appearing on a label, in order to reflect the current FAISD handbook
- the net contents of a veterinary product, but only if:
- the variation will not result in the instructions for use or disposal of the product—or container for the product—being modified or affected
- the net contents are within the range recorded in the register for the product.
Notifiable variations also include the variation of an approved label that occurs as a result of varying any of the above items.
The full list of notifiable variations and information on notification submissions can be found under Minor variations.