Document ID: chunk:federal_register_of_legislation:C2014C00508:clause:1_8s
Version: federal_register_of_legislation:C2014C00508
Segment Type: clause
Provision Reference: sch 1 cl 8S
Character Range: 35736–37372

8S  Notice of certain proposed decisions
 (1) The APVMA must give the applicant written notice of what it proposes to do before it:
 (a) refuses an application, other than on preliminary assessment; or
 (b) approves (or re‑approves) or registers (or re‑registers) an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or
 (c) if the application is to vary relevant particulars or conditions—varies the relevant particulars or conditions other than in accordance with the application.
Note: For notices in relation to reconsiderations, see Division 4 of Part 2.
 (2) The notice must:
 (a) for notice under paragraph (1)(b)—set out the proposed instructions and relevant particulars; and
 (b) for notice under paragraph (1)(c)—set out the proposed variation; and
 (c) include a draft statement of reasons for the proposed course of action; and
 (d) set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and
 (e) invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice.
 (3) 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:
 (a) already given to the APVMA by, or on behalf of, the applicant; or
 (b) set out in the notice under paragraph (2)(d).
 (4) The APVMA is not required to comply with this section more than once in relation to a particular application.

Division 6—Listed chemical products and established standards