8AFStandards made by APVMA

#### 8AF Standards made by APVMA (1) Before making or varying a standard under section 6E of the Code, the APVMA must: (a) consider whether it is necessary to make the standard or variation, having regard to any relevant standards specified in any of the following: (i) the British Pharmacopoeia; (ii) the British Pharmacopoeia (Veterinary); (iii) the European Pharmacopoeia; (iv) the United States Pharmacopeia; (v) the FAO and WHO Specifications for Pesticides; and (b) publish a notice in the Gazette and on the APVMA’s website stating: (i) that it proposes to make or vary the standard; and (ii) the reasons that the APVMA considers it is necessary to make the standard or variation; and (iii) how to obtain more information about the proposed standard or variation; and (c) prepare a draft of the standard or variation the APVMA proposes to make; and (d) publish on the APVMA’s website: (i) the draft standard or variation; and (ii) if the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness—a statement to that effect; and (iii) an invitation to the public to make a written submission on the draft standard or variation within the period stated in the invitation. (2) The period mentioned in subparagraph (1)(d)(iii) must be not less than 28 days after the publication of the invitation, unless the APVMA determines that the standard or variation is necessary to prevent imminent risk to persons of death, serious injury or serious illness. (3) In deciding whether to make the standard or variation, the APVMA must consider any submissions received in accordance with the invitation mentioned in subparagraph (1)(d)(iii). (4) If the APVMA makes or varies a standard under section 6E of the Code, the APVMA must publish a notice in the Gazette and on the APVMA’s website stating: (a) that it has made the standard or variation; and (b) its reasons for making or varying the standard; and (c) how to obtain more information about the standard or variation. (4A) For the purposes of subparagraph 6(2)(a)(iii) of the Act, a labelling standard must include requirements relating to one or more of the following: (a) the presentation of the label, including the size, colour, legibility, dimensions, layout and format of the label; (b) the display of the label; (c) the information contained on the label. > Note: A label can contain information in addition to the information required by legislation. (5) If the APVMA decides, after taking into account the matters mentioned in subregulation (3), not to make the standard or variation, the APVMA must publish a notice in the Gazette stating: (a) that it has abandoned the development of the standard or variation; and (b) the reasons for abandoning the development of the standard or variation; and (c) how to obtain more information about the decision to abandon the development of the standard or variation.