8AOMatters for notice following preliminary assessment

#### 8AO Matters for notice following preliminary assessment (1) For subparagraphs 11(2)(a)(ii) and 28(2)(a)(ii) and paragraph 110A(2)(b) of the Code, this regulation prescribes the matters that must be set out in a notice under subsection 11(2), 28(2) or 110A(2) of the Code. (2) The matters are the following: (a) that the application to which the notice relates has passed preliminary assessment; (b) the section of the Code under which the application will be determined; (c) the date on which the assessment of the application will commence; (d) if an amount of application fee payable in relation to the application under subregulation 70(2) is unpaid: (i) the balance of the application fee that is payable; and (ii) that the balance must be paid within 28 days of the date of the notice; (e) that the APVMA may determine that: (i) the application is more correctly categorised as an application mentioned in a different item of the table in clause 2.1 of Schedule 6 to the item in relation to which any fee has been paid; or (ii) different modules, levels and types mentioned in Schedule 7 are necessary for the application; and that if it does so, a further amount of application fee may be payable and the assessment period may change; (f) the number of copies (if any) of the application that must be given to the APVMA and the form in which those copies must be given; (g) that if copies of the application are required, the copies must be given to the APVMA within 28 days of the date of the notice; (h) the assessment period for the application and the expected date by which the application will be determined; (i) if the modular assessment period applies to the application—the modules to be completed in relation to the application; (j) that if the APVMA or another prescribed authority makes a request under section 159 of the Code, the assessment period will be extended; (k) for an applicant who is a nominated agent for an approval or registration—the applicant’s obligations under subsection 152(2) of the Code; (l) that if the applicant becomes aware of any information (new information) that contradicts any information given to the APVMA or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria, the applicant must give the new information to the APVMA in accordance with sections 160A and 161 of the Code; (m) that if the APVMA does not determine the application within the assessment period for the application (or the extended application period, if applicable), the applicant may: (i) notify the APVMA under subsection 165(3) of the Code that the applicant wishes to treat the application as having been refused; and (ii) apply under subsection 167(1) of the Code for a review of the decision; (n) that the applicant may withdraw the application in accordance with section 8D of the Code.