Document ID: chunk:federal_register_of_legislation:C2024C00508:section:160a
Version: federal_register_of_legislation:C2024C00508
Segment Type: section
Provision Reference: s 160A
Character Range: 442968–445333

160A  Notification of new information to APVMA in respect of pending application
 (1) This section applies if:
 (a) an application has been lodged with the APVMA for:
 (i) approval of an active constituent for a proposed or existing chemical product; or
 (ii) registration of a chemical product; or
 (iv) a permit in respect of such an active constituent or in respect of a chemical product; or
 (v) a licence in respect of the manufacture of a chemical product; or
 (vi) approval of a label for containers for a chemical product; or
 (vii) variation of the relevant particulars or conditions of the approval of an active constituent, of the registration of a chemical product or of the approval of a label for containers for a chemical product; and
 (b) the APVMA has not determined the application; and
 (c) the applicant becomes aware of any relevant information in relation to the constituent, in relation to the product or any of its constituents or in relation to the label.
 (2) The applicant must, as soon as the applicant becomes aware of the information, give the information to the APVMA.
 (2A) A person commits an offence if the person contravenes subsection (2).
Penalty: 300 penalty units.
 (2B) Subsection (2) is a civil penalty provision.
Note: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.
 (4) Information is relevant information if it:
 (a) contradicts any information that:
 (i) was given to the APVMA by the applicant in an application mentioned in paragraph (1)(a); and
 (ii) relates to particulars prescribed by the regulations for the purposes of paragraph 19(c) or 20(1)(c) or relates to the matters covered by subparagraph 21(c)(iv) or (iva); or
 (b) shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria or that the label may not meet the labelling criteria.
 (5) A corporation is taken to be aware of any information if a related corporation is aware of that information.
 (6) The question whether 2 corporations are related to each other is to be determined in the same way as that question would be determined under the Corporations Act 2001.
 (7) Any information given to the APVMA under this section must be given in writing signed by the applicant.
Note: For giving information electronically, see section 156A.