Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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.