26BApplications for prescribed variations

#### 26B Applications for prescribed variations (1) The holder may apply to the APVMA for one or more prescribed variations of the relevant particulars of an approval or registration. (2) The application must meet the application requirements. > Note: For meets the application requirements, see section 8A. (3) The APVMA may alter the application with the written consent of the applicant. (4) A prescribed variation is a variation of a kind: (a) determined by the APVMA under subsection (6); or (b) prescribed by the regulations. (5) The APVMA must not determine a kind of variation under subsection (6) unless it is satisfied that, with the relevant particulars so varied: (a) for an active constituent—the constituent would meet the safety criteria; and (b) for a chemical product—the product would: (i) meet the safety criteria, the trade criteria and the efficacy criteria; or (ii) comply with the established standard for the product; and (c) for a label for a chemical product—the label would: (i) meet the labelling criteria; or (ii) comply with the established standard for the product. (6) The APVMA may, by legislative instrument, determine a kind of variation for the purposes of paragraph (4)(a). (7) If the application does not meet the application requirements, the APVMA must: (a) notify the holder in writing of that fact; and (b) include in the notice the reasons why the holder’s application does not meet the application requirements.