Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:8am
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 8AM
Character Range: 46148–47910

8AM  Publication requirements—approvals and variations of approvals of active constituents
 (1) For paragraphs 8H(2)(e) and 8J(2)(d) of the Code, this regulation sets out the information that must be included in a notice published in the Gazette under those sections in relation to:
 (a) the approval of an active constituent; or
 (b) the variation of the relevant particulars or conditions of the approval of an active constituent.
 (2) The information is:
 (a) the name of the applicant for the approval or variation; and
 (b) the application number for the application for approval or variation; and
 (c) the name of the active constituent; and
 (d) the distinguishing number given to the active constituent by the APVMA when the APVMA approved the active constituent; and
 (e) a short description of the application and its purpose, including the way in which the active constituent is intended to be used.
 (3) The following information must also be published by the APVMA on the APVMA website:
 (a) the information mentioned in paragraphs (2)(a) to (e);
 (b) brief details about the APVMA's decision.
 (4) For each item of information relied on by the APVMA in making its decision, the following details must also be published by the APVMA on the APVMA website:
 (a) the details for the information mentioned in paragraphs (a) to (e) of the definition of application information details in subregulation 3(1);
 (b) if the item of information was given to the APVMA in connection with the application by the applicant or a person on behalf of the applicant:
 (i) the data number given to the item of information by the APVMA; and
 (ii) unless the information is publicly available—the name and address of the authorising party for the item of information.