Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:8ap
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 8AP
Character Range: 53202–55557

8AP  Matters for notice—applications for technical assessments etc.
 (1) The APVMA must give a person a notice if:
 (a) the person lodges an application for the APVMA to provide an assessment of a technical nature, and the APVMA decides to provide that assessment (see regulation 8AS); or
 (b) the person lodges an application for the APVMA to:
 (i) make an interchangeable constituent determination (see regulation 19AEB); or
 (ii) make or vary an ingredient determination (see clause 10 of Schedule 3AA).
 (2) The notice must set out the following:
 (a) the date on which the assessment or the determination will commence;
 (b) if an amount of application fee payable for 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;
 (c) if the applicant must give copies of the application to the APVMA:
 (i) the number of copies that must be given; and
 (ii) the form in which those copies must be given; and
 (iii) that the copies must be given to the APVMA within 28 days of the date of the notice;
 (d) the assessment period for the application and the expected date by which the application will be determined;
 (e) the modules to be completed in relation to the application;
 (f) that the assessment period will be extended if the APVMA or another prescribed authority makes a request under section 159 of the Code;
 (g) 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 review of the decision;
 (h) that the applicant may withdraw the application in accordance with section 8D of the Code.
 (3) The notice must be given to the person within 1 month of the day on which the person lodges the application.
 (4) If a person lodges an application under regulation 8AS for the APVMA to provide an assessment of a technical nature, and the APVMA decides not to provide that assessment, the APVMA must notify the person of that decision within 1 month of the day on which the person lodges the application.