Commonwealth Consolidated Regulations

AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS 1995 - REG 19AD

  (1)   This regulation applies to an application for variation of the relevant particulars or conditions of:

  (a)   the registration of a chemical product; or

  (b)   the approval of a label for a container for a chemical product.

  (2)   For   paragraph   28(2)(b) of the Code, the details are:

  (a)   the name of the applicant; and

  (b)   the application number; and

  (c)   the name of the chemical product; and

  (d)   if the application is in relation to the registration of a chemical product--the distinguishing number that the APVMA gave to the product when it decided to register the product; and

  (e)   the name of each of the active constituents of the chemical product; and

  (f)   a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and

  (g)   for any reference active constituent mentioned in the application:

  (i)   the name of the reference active constituent; and

  (ii)   if the active constituent is an approved active constituent--the distinguishing number that the APVMA gave to the active constituent when the approval was granted; and

  (h)   for any reference chemical product mentioned in the application:

  (i)   the name of the reference chemical product; and

  (ii)   if the chemical product has been registered--the distinguishing number that the APVMA gave to the chemical product when the APVMA decided to register the product; and

  (i)   a short description of each item of information contained in, or accompanying, the application in compliance with subparagraph   8A(a)(v) of the Code, including the application information details for the item of information; and

  (ia)   if the APVMA were to make a variation as a result of the application and this may result in:

  (i)   an extension of a protection period in relation to protected information; or

  (ii)   an extension of a limitation period for information covered by an item in the table in subsection   34M(1) of the Code;

    a statement in relation to this matter; and

  (j)   any other information that the APVMA considers to be relevant to its decision on the application.