33APVMA may require information, reports, results or samples

#### 33 APVMA may require information, reports, results or samples (1) The APVMA may, by written notice given to the holder of the approval or registration, require the holder, within a reasonable period stated in the notice or such further period as the APVMA allows, to do one or more of the following for the purposes of the reconsideration: (a) give to the APVMA information of a kind stated in the notice; (b) carry out a search of published literature for information and give a report to the APVMA on the results of that search; (c) conduct, or cause to be conducted, trials or laboratory experiments and give the results of the trials or experiments to the APVMA; (d) give to the APVMA, or to another body specified in the notice, a sample of an active constituent, or of a chemical product or any of its constituents, for the purpose of analysis by an approved analyst. The information, trials, experiments or analysis must be relevant to the reconsideration. (1A) The period stated in the notice must be no longer than the period prescribed by the regulations. (1B) The APVMA may allow a further period only in the circumstances prescribed by the regulations. (1C) The power under subsection (1) includes the power to require the holder to give to the APVMA information, a report, results or a sample in addition to any information, report, results, or sample previously given by the holder to the APVMA under any provision of this Code other than this section. (1D) Any information, report, results or sample that the holder has to give to the APVMA or another body under subsection (1) must be given as follows: (a) information, a report or results must be given in writing: (i) signed by the holder; or (ii) attached to a covering letter signed by the holder; (b) a sample must be: (i) labelled with a label signed by the holder; or (ii) attached to a covering letter signed by the holder. > Note: For giving information electronically, see section 156A. (2) The holder must comply with a requirement made of the holder under subsection (1). > Note: A person does not commit an offence by failing to do something the person is not capable of doing. See subsections 4.2(1) and (4) of the Criminal Code. (3) Subsection (2) does not apply if, before the end of the period stated in the notice, the holder requests the APVMA under section 42 to cancel the approval of the constituent or the registration of the product, as the case may be, and the APVMA complies with the request. (4) The holder commits an offence of strict liability if the holder contravenes subsection (2). Penalty: 120 penalty units. > Note 1: For strict liability, see section 6.1 of the Criminal Code. > Note 2: A defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code. (5) Subsection (2) is a civil penalty provision. > Note 1: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions. > Note 2: For the evidential burden in civil penalty proceedings in relation to the matter in subsection (3), see section 145CD.