Approval of active constituents for which information is not readily available

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.

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, 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 (including the BP (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

An application is still required for approval of the active constituent. Usually this will be under an Item 17, or as part of a modular application including product registration (eg Item 10 or 27).

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

  • 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 (including the BP (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 requirement for approval.

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