5Prescribed variations

5 Prescribed variations

The following table prescribes, for the purposes of paragraph 26B(4)(a) of the Code, prescribed variations of the relevant particulars that are listed in an item in the table, for the registrations listed in the table for that item.

<table cellspacing="0" cellpadding="0" style="width:100%; border:1pt solid #000000; border-collapse:collapse"><thead><tr><td colspan="3" style="border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Prescribed variations</span></p></td></tr><tr style="height:31.65pt"><td style="width:9%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Item</span></p></td><td style="width:46%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Prescribed variation of relevant particular</span></p></td><td style="width:45%; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt; font-weight:bold">Registration</span></p></td></tr></thead><tbody><tr style="height:83.25pt"><td style="width:9%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">1</span></p></td><td style="width:46%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt; background-color:#ffffff"><span style="font-size:10pt">A variation of either or both of the following particulars:</span></p><div style="margin-top:14pt; background-color:#ffffff"><p class="ListParagraph" style="margin-top:0pt; margin-left:21.8pt; margin-bottom:0pt; text-indent:-21.8pt; font-size:10pt"><span style="font-size:12pt"><span style="font-size:10pt">(a)</span></span><span style="width:10.7pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>the name of a manufacturer of a chemical product in Australia;</span></p></div><div style="margin-bottom:14pt; background-color:#ffffff"><p class="ListParagraph" style="margin-top:0pt; margin-left:21.8pt; margin-bottom:0pt; text-indent:-21.8pt; font-size:10pt"><span style="font-size:12pt"><span style="font-size:10pt">(b)</span></span><span style="width:10.14pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>the address of each site in Australia at which the chemical product is manufactured by a manufacturer;</span></p></div><p style="margin-top:3pt; background-color:#ffffff"><span style="font-size:10pt">but only if, under the varied particulars:</span></p><div style="margin-top:14pt; background-color:#ffffff"><p class="ListParagraph" style="margin-top:0pt; margin-left:21.8pt; margin-bottom:0pt; text-indent:-21.8pt; font-size:10pt"><span><span>(c)</span></span><span style="width:10.7pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>the manufacturer and the address of each manufacturing site are in Australia; and</span><span> </span><span>either:</span></p></div><ol class="awlist1" style="margin:0pt; padding-left:0pt"><li class="ListParagraph" style="margin-top:0pt; margin-left:54pt; margin-bottom:0pt; text-indent:-18pt; font-size:10pt"><span style="width:6.9pt; font:7pt 'Times New Roman'; display:inline-block"></span><span>the manufacturer is the holder of a valid licence under Part 8 of the Code that authorises carrying out a step in the manufacture of the chemical product at premises at the site; or</span></li><li class="ListParagraph" style="margin-top:0pt; margin-left:54pt; margin-bottom:0pt; text-indent:-18pt; font-size:10pt"><span style="width:6.34pt; font:7pt 'Times New Roman'; display:inline-block"></span><span style="font-size:7pt"></span><span>the manufacturer is an exempt person as mentioned in paragraph 121(4)(a) of the Code in relation to the manufacture of the chemical product</span></li></ol></td><td style="width:45%; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">any registration of a chemical product other than a chemical product that is prescribed under subregulation</span><span style="font-size:10pt"> </span><span style="font-size:10pt">59(1)</span></p></td></tr><tr style="height:83.25pt"><td style="width:9%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">2</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt"></span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt"></span></p></td><td style="width:46%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">A variation of either or both of the following particulars:</span></p><p style="margin-top:3pt; margin-left:36pt; text-indent:-29.05pt; line-height:12pt"><span style="font-size:10pt">(a)</span><span style="font-size:10pt"> </span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt">the name of a manufacturer of a chemical product outside Australia;</span></p><p style="margin-top:3pt; margin-left:36pt; text-indent:-29.05pt; line-height:12pt"><span style="font-size:10pt">(b)</span><span style="font-size:10pt"> </span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt; background-color:#ffffff">the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts secondary steps of manufacture (excluding the step of a biological assay for an immunobiological product) in relation to the chemical product</span><span style="font-size:10pt">, but only if, under the varied particulars:</span></p><p style="margin-top:3pt; margin-left:56.55pt; margin-bottom:8pt; text-indent:-20.55pt; line-height:12pt"><span style="font-size:10pt">(i)</span><span style="font-size:10pt"> </span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt"></span><span style="font-size:10pt">the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code</span></p></td><td style="width:45%; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt; background-color:#ffffff"><span style="font-size:10pt">a registration of a chemical product, other than a chemical product that is prescribed under subregulation</span><span style="font-size:10pt"> </span><span style="font-size:10pt">59(1)</span></p></td></tr><tr style="height:83.25pt"><td style="width:9%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">3</span></p></td><td style="width:46%; border-right:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">A variation of either or both of the following particulars:</span></p><p style="margin-top:3pt; margin-left:35.3pt; margin-bottom:8pt; text-indent:-21.3pt; line-height:12pt"><span style="font-size:10pt">(a)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">the name of a manufacturer of a </span><span style="font-size:10pt"></span><span style="font-size:10pt">chemical product outside Australia;</span></p><p style="margin-top:3pt; margin-left:35.3pt; margin-bottom:8pt; text-indent:-21.3pt; line-height:12pt"><span style="font-size:10pt">(b)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">the address of each site outside Australia at which the chemical product is manufactured by a manufacturer that conducts primary steps of manufacture in relation to the chemical product, but only if, under the varied particulars:</span></p><p style="margin-top:3pt; margin-left:56.55pt; margin-bottom:8pt; text-indent:-21.25pt; line-height:12pt"><span style="font-size:10pt">(i)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">at the time of the holder’s application, the site of manufacture is entered in the Register as a site for another chemical product of the holder, and the manufacturer conducts the same steps of manufacture in relation to the other chemical product; and</span></p><p style="margin-left:56.55pt; margin-bottom:8pt; text-indent:-21.25pt; line-height:11.75pt"><span style="font-size:10pt">(ii)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">the holder of the registration of the chemical product possesses evidence that each step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code</span></p></td><td style="width:45%; border-bottom:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt; background-color:#ffffff"><span style="font-size:10pt">a registration of a chemical product, other than</span></p><div style="margin-top:3pt; margin-left:18pt; background-color:#ffffff"><p style="margin-left:18pt; text-indent:-18pt; line-height:12pt"><span style="font-size:10pt">(a)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">a chemical product that is prescribed under subregulation</span><span style="font-size:10pt"> </span><span style="font-size:10pt">59(1); or</span></p></div><div style="margin-top:3pt; margin-left:18pt; background-color:#ffffff"><p style="margin-left:18pt; text-indent:-18pt; line-height:12pt"><span style="font-size:10pt">(b)</span><span style="font-size:7pt"> </span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:7pt"></span><span style="font-size:10pt">an immunobiological product</span></p></div><p style="margin-top:3pt; line-height:12pt; background-color:#ffffff"><span style="font-size:10pt"></span></p></td></tr><tr style="height:83.25pt"><td style="width:9%; border-right:1pt solid #000000; padding-right:4.9pt; padding-left:4.9pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">4</span></p></td><td style="width:46%; border-right:1pt solid #000000; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">A variation of one or more constituents of a chemical product if:</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(a) the constituent (the</span><span> </span><span style="font-weight:bold; font-style:italic">original constituent</span><span>) is replaced with another constituent (the</span><span> </span><span style="font-weight:bold; font-style:italic">replacement constituent</span><span>); and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(b) the original constituent is not an active constituent of the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(c) the replacement constituent will not be an active constituent of the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(d) the original and replacement constituents have the same purpose in the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(e) the original and replacement constituents differ only in solvates or hydrates; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(f) the original and replacement constituents have the same:</span></p><p style="margin-left:41.4pt; text-indent:-14.2pt; line-height:12pt"><span style="font-size:10pt">(i) pH; and</span></p><p style="margin-left:41.4pt; text-indent:-14.2pt; line-height:12pt"><span style="font-size:10pt">(ii) dissolution profile; and</span></p><p style="margin-left:41.4pt; text-indent:-14.2pt; line-height:12pt"><span style="font-size:10pt">(iii) hydrophilic or hydrophobic behaviour; and</span></p><p style="margin-left:41.4pt; text-indent:-14.2pt; line-height:12pt"><span style="font-size:10pt">(iv) hygroscopic behaviour; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(g) neither the original nor replacement constituent are a nanomaterial; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33% of the length of the original constituent’s hydrocarbon chain; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(i) the replacement constituent does not introduce material of human or animal origin into the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(l) the variation does not require the formulation type entered in the Register for the product to be varied; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(m) in the case of a product that has 9 or more constituents entered in the Register for the product—the variation is to no more than 25% of the number of constituents entered in the Register for the product; and</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(n) in the case of a product that has less than 9 constituents entered in the Register for the product—the variation is to one or 2 of the constituents entered in the Register for the product</span></p></td><td style="width:45%; padding-right:4.9pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">a registration of a chemical product, other than a chemical product that is:</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(a) an antibiotic product; or</span></p><p style="margin-top:3pt; margin-left:14.2pt; text-indent:-14.2pt; line-height:normal; font-size:10pt"><span>(b) an immunobiological product; or</span></p><p style="margin-top:3pt; line-height:12pt"><span style="font-size:10pt">(c) a product that is administered through direct injection into an animal</span></p></td></tr></tbody></table>