8SNotice of certain proposed decisions

#### 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 registers an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or (c) varies, under section 29, relevant particulars or conditions in a way other than set out in 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. > Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8X. (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.