Applications for approval of prescribed active constituents
14C Applications for approval of prescribed active constituents
A person may apply to the APVMA for approval of a prescribed active constituent.
For prescribed active constituent, see subsection (4).
The application must meet the application requirements.
For meets the application requirements, see section 8A.
The APVMA may alter the application with the written consent of the applicant.
A prescribed active constituent is an active constituent that:
is for a proposed or existing chemical product; and
is of a kind:
prescribed by the regulations for the purposes of this subparagraph; or
determined by the APVMA under subsection (6).
The APVMA must not determine a kind of active constituent under subsection (6) unless it is satisfied that the kind of active constituent would meet the safety criteria.
The APVMA may, by legislative instrument, determine a kind of active constituent for the purposes of subparagraph (4)(b)(ii).
Decision on application
The APVMA must approve the active constituent that is the subject of the application if it is satisfied that:
the application meets the application requirements; and
the active constituent is a prescribed active constituent; and
none of the circumstances determined in an instrument under subsection (9) apply in relation to the applicant.
For notice of approval, see section 8F.
Otherwise, the APVMA must refuse the application.
For notice of refusal, see section 8G.
Disqualifying circumstances
The APVMA may, by legislative instrument, determine circumstances for the purposes of paragraph (7)(c).
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