Summaries of applications for chemical products that are not the same as a registered chemical product
8D Summaries of applications for chemical products that are not the same as a registered chemical product
This regulation applies to an application for:
registration of a chemical product that is not a chemical product mentioned in paragraph 8E(1)(a); or
approval of a label for a container for a chemical product mentioned in paragraph (a).
For paragraph 11(2)(b) of the Code, the details are:
the name of the applicant; and
the application number; and
the name of the chemical product; and
the chemical product number; and
the name of each of the active constituents of the chemical product; and
a short description of the application and its purpose, including the way in which the chemical product is intended to be used; and
for any reference active constituent mentioned in the application:
the name of the reference active constituent; and
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
for any reference chemical product mentioned in the application:
the name of the reference chemical product; and
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
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
any other information that the APVMA considers to be relevant to its decision on the application.
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