Approval of active constituents for which information is not readily available - Veterinary

The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, normally requires the APVMA to be satisfied about a number of things before granting an approval for an active constituent, including that:

  • an application has been made and the application meets the application requirements
  • the active constituent meets the statutory safety criteria.

In limited circumstances, the APVMA may approve an active constituent for a proposed or existing chemical product without having regard to all of the information we are required to have regard to, provided we are satisfied on the information that is readily available that the constituent would meet the safety criteria. We can approve an active constituent in this way whether or not an application has been made. If an application has not been made, the APVMA will be entered in the Record as the holder of the approval.

1. Which legislative provisions apply?

Section 14A of the Agvet Code provides that the APVMA may approve an active constituent for a proposed or existing chemical product, whether or not an application for approval has been made, if:

  • either of the following applies:
    • we consider that the information required in respect of the constituent is not readily available, or
    • the constituent is, or is part of, a product which has a standard specified in the European pharmacopoeia, the British pharmacopoeia (veterinary), the United States pharmacopeia or any other publication considered by the APVMA to be appropriate, and
  • having regard to information that is readily available, we are satisfied that the active constituent would meet the safety criteria.

2. Principles

In considering whether it is appropriate to approve an active constituent under section 14A we take into account:

  • whether an application has been lodged with the APVMA for approval of the active constituent under section 14A
  • all information provided in support of the application
  • whether or not there is readily available information to satisfy us that the active constituent would meet the safety criteria, in particular:
    • whether the constituent is, or is part of, a product in respect of which a standard is specified in the European pharmacopoeia, the British pharmacopoeia (veterinary), the United States pharmacopeia or any other publication that we consider appropriate
    • whether the characteristics of the active constituent are well known and understood due to common use in industrial, non-agricultural or non-veterinary uses; for example, a substance may be commonly used in food for human consumption.
  • whether it would be preferable to exempt the active constituent from the operation of the Agvet Code (or parts of it).

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