34Reconsideration by APVMA

#### 34 Reconsideration by APVMA (1) The APVMA must affirm the approval or registration if, and only if, it is satisfied: (a) for an active constituent—that the constituent meets the safety criteria; and (b) for a chemical product—that the product meets the safety criteria, the trade criteria and the efficacy criteria; and (c) for a label—that the label meets the labelling criteria; and (d) that the constituent, product or label complies with any requirement prescribed by the regulations. (2) Subsection (1) applies only to the extent that the APVMA decides to reconsider matters covered by the subsection. (3) For the purposes of subsection (1), the APVMA: (a) must have regard to: (i) any information given, or submissions made, to the APVMA in response to a notice given under subsection 32(1); and (ii) any submissions made to the APVMA in response to an invitation under paragraph 32(2A)(b) or 34AB(2)(f); and (iii) any information given by the holder in response to an invitation given by the APVMA (whether or not under this Code) in relation to the constituent, product or label; and (iv) any information, report, results or sample given to the APVMA in response to a notice given under section 33; and (v) any information given to the APVMA as required by section 161 in relation to the constituent, product or label; and (vi) any other information that it considers necessary to enable it to make a decision on the reconsideration; but (b) must not take into account any submission, information, report, results or sample not covered by paragraph (a).