Agricultural and Veterinary Chemicals Code Act 1994

The APVMA may approve an active constituent for a proposed or existing chemical product if:

either of the following applies:

the APVMA considers that information it requires in respect of the constituent is not readily available;

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 considered by the APVMA to be appropriate; and

having regard to information that is readily available, the APVMA is satisfied that the constituent would meet the safety criteria.

Subsection (1) applies:

despite subsection 14(2); and

whether or not an application has been made for approval of the constituent.

If the APVMA approves an active constituent under this section without an application having been made for the approval, the APVMA must, under paragraph 19(a), be entered in the Record as the holder of the approval.