Notice of certain proposed decisions
8S Notice of certain proposed decisions
The APVMA must give the applicant written notice of what it proposes to do before it:
refuses an application, other than on preliminary assessment; or
approves or registers an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or
varies, under section 29, relevant particulars or conditions in a way other than set out in the application.
For notices in relation to reconsiderations, see Division 4 of Part 2.
The notice must:
for notice under paragraph (1)(b)—set out the proposed instructions and relevant particulars; and
for notice under paragraph (1)(c)—set out the proposed variation; and
include a draft statement of reasons for the proposed course of action; and
set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and
invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.
This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8X.
The APVMA is not required to take account of anything given in response to the invitation under paragraph (2)(e) that is not related to information:
already given to the APVMA by, or on behalf of, the applicant; or
set out in the notice under paragraph (2)(d).
The APVMA is not required to comply with this section more than once in relation to a particular application.
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