70BRecategorised applications

#### 70B Recategorised applications (1) This regulation applies if: (a) both of the following apply: (i) the fee mentioned in subregulation 70(2) (the application fee) has been paid in relation to an application on the basis that the application is of a kind mentioned in an item of the table in clause 2.1 of Schedule 6 (the original item); (ii) the APVMA determines, at any time after preliminary assessment of the application, that the application is more correctly categorised as an application of a kind mentioned in a different item of the table (the recategorised item); or (b) both of the following apply: (i) the application fee has been paid in relation to an application on the basis that particular modules, levels and types mentioned in Schedule 7 (the original modules) are necessary for the application; (ii) the APVMA considers, at any time after preliminary assessment of the application, that different modules, levels and types mentioned in Schedule 7 (the recategorised modules) are necessary for the application. (2) If the application fee is the same as the fee payable under subregulation 70(2) for the recategorised item or recategorised modules, the APVMA must notify the applicant, in writing: (a) that the APVMA has recategorised the application and will proceed with the assessment of the application; and (b) if the assessment period for the recategorised item or recategorised modules is different from the assessment period for the original item or original modules—of the assessment period for the application. (3) If the application fee is less than the fee payable under subregulation 70(2) for the recategorised item or recategorised modules: (a) the APVMA must notify the applicant, in writing: (i) that the APVMA has recategorised the application; and (ii) that the applicant must pay the difference between the application fee and the fee payable under subregulation 70(2) for the recategorised item or recategorised modules (the additional amount) before the APVMA can determine the application; and (iii) that the additional amount is payable within 28 days of the date of the notice; and (iv) that the APVMA must refuse the application if the additional amount is not paid by that date; and (v) that the applicant may withdraw the application; and (vi) if the assessment period for the recategorised item or recategorised modules is different from the assessment period for the original item or original modules—of the assessment period for the recategorised item or recategorised modules; and (b) for section 164 of the Code, the applicant must pay the additional amount within 28 days of the date of the notice; and (c) for paragraph 164(8)(b) of the Code, the APVMA may waive the additional amount if the application is refused on the basis that the additional amount has not been paid within 28 days of the date of the notice. (4) If the application fee is more than the fee payable under subregulation 70(2) for the recategorised item or recategorised modules: (a) the APVMA must notify the applicant, in writing: (i) that the APVMA has recategorised the application; and (ii) of the amount of the fee for the recategorised item or recategorised modules; and (iii) that the applicant is entitled to a refund of the difference between the application fee and the fee payable under subregulation 70(2) for the recategorised item or recategorised modules; and (iv) that the APVMA will proceed with the assessment of the application; and (v) if the assessment period for the recategorised item or recategorised modules is different from the assessment period for the original item or original modules—of the assessment period for application; and (b) the APVMA must, as soon as practicable, remit to the applicant the difference between the application fee and the fee payable under subregulation (2) for the recategorised item or recategorised modules.