Product and label variations that do not require APVMA notification

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has provided advice to product holders on the types of product or label updates that can be made by a product holder without requiring APVMA application or notification.

These are variations that do not affect the relevant particulars or conditions of registration of a product or label, and include:

  • corrections to typographical errors and spelling mistakes
  • updating a Mode of Action group
  • updating reference to a product holder on a label if this has changed (for example, in the resistance management strategy)
  • compatibility statements (this excludes ‘incompatibility’ statements that have been required by the APVMA)
  • changes to packaging material
  • changing from one source of approved active constituent to another.

Further information about minor variations is available on our website.

While these variations have always been permitted, this update aims to clearly communicate this variation type to stakeholders.

We are seeking feedback on this information from stakeholders. Please email any comments on the information in relation to variations that can be made without notifying the APVMA to enquiries@apvma.gov.au with the subject header 'Variations that can be made without notifying the APVMA'.

We are grateful for comments by 7 December 2020.

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URL

http://apvma.gov.au/node/74416
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