Commonwealth Consolidated Regulations

AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 - REG 8AQ

  (1)   This regulation applies to an application for an extension or extensions of a permit under subsection   115(3) of the Code.

  (2)   Within 1 month of the application being lodged, the APVMA must give the applicant a notice setting out the following:

  (a)   that the application will be determined under section   115 of the Code;

  (b)   the date on which the assessment of the application will commence;

  (c)   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;

  (d)   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;

  (e)   that any copies must be given to the APVMA within 28 days of the date of the notice;

  (f)   the assessment period for the application and the expected date by which the application will be determined;

  (fa)   that the assessment period will be extended if the APVMA or another prescribed authority makes a request under section   159 of the Code;

  (g)   if the modular assessment period applies to the application--the modules to be completed in relation to the application;

  (h)   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;

  (i)   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;

  (j)   that the applicant may withdraw the application in accordance with section   8D of the Code.