Document ID: chunk:federal_register_of_legislation:C2014C00508:clause:1_14a
Version: federal_register_of_legislation:C2014C00508
Segment Type: clause
Provision Reference: sch 1 cl 14A
Character Range: 50329–51436

14A  Approval of active constituents for which information is not readily available
 (1) The APVMA may approve an active constituent for a proposed or existing chemical product if:
 (a) either of the following applies:
 (i) the APVMA considers that information it requires in respect of the constituent is not readily available;
 (ii) 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 Pharmacopoeia or any other publication considered by the APVMA to be appropriate; and
 (b) having regard to information that is readily available, the APVMA is satisfied that the constituent would meet the safety criteria.
 (2) Subsection (1) applies:
 (a) despite subsection 14(2); and
 (b) whether or not an application has been made for approval of the constituent.
 (3) 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(1)(a), be entered in the Record as the holder of the approval.