17CConditions of approval or registration—active constituents and chemical products

#### 17C Conditions of approval or registration—active constituents and chemical products (1) For paragraph 23(1)(a) of the Code, the table sets out conditions to which the approval of an active constituent for a proposed or existing chemical product is subject. ```html <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Conditions for approval of active constituent</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Condition</span></p></td></tr></thead><tbody><tr><td style="width:10.08%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:89.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The active constituent must be manufactured in accordance with the composition and purity entered for the active constituent in the Record in accordance with paragraph</span><span> </span><span>15(1)(d)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The active constituent must be manufactured by the manufacturer whose name is entered for the active constituent in the Record in accordance with paragraph</span><span> </span><span>15(1)(e)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The active constituent must be manufactured at a site of manufacture entered for the active constituent in the Record in accordance with paragraph</span><span> </span><span>15(1)(f)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The identifying information for the holder of the approval, and the nominated agent (if any), of the active constituent must be the identifying information for the holder and nominated agent (if any) entered for the active constituent in the Record</span></p></td></tr></tbody></table> ``` (2) For paragraph 23(1)(a) of the Code, the table sets out conditions to which the registration of a chemical product is subject. ```html <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Conditions for registration of chemical product</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Condition</span></p></td></tr></thead><tbody><tr><td style="width:10.08%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="CU_375024"></a><a id="CU_371171"></a><span>1</span></p></td><td style="width:89.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The chemical product must contain each of the constituents entered for the chemical product in the Register in accordance with paragraph</span><span> </span><span>16(b)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The chemical product must be manufactured:</span></p><p class="Tablea"><span>(a) in accordance with the particulars entered for the chemical product in the Register in accordance with paragraphs 16(b), (c), (d) and (da); and</span></p><p class="Tablea"><span>(b) by a manufacturer whose name is entered for the chemical product in the Register in accordance with paragraph</span><span> </span><span>16(g); and</span></p><p class="Tablea"><span>(c) at a site of manufacture entered for the chemical product in the Register in accordance with paragraph</span><span> </span><span>16(h)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A chemical product manufactured in Australia must not be supplied unless the APVMA has determined it is satisfied that each holder of a licence to carry out steps in the manufacture of the product is complying with the following conditions of the licence:</span></p><p class="Tablea"><span>(a) any conditions imposed on the licence under subsections</span><span> </span><span>126(1) and (2) of the Code;</span></p><p class="Tablea"><span>(b) the condition mentioned in paragraph</span><span> </span><span>126(4)(a) of the Code, if the licence is subject to that condition;</span></p><p class="Tablea"><span>(c) any of the conditions mentioned in subregulations</span><span> </span><span>61(3) to (7A) to which the licence is subject</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>A chemical product manufactured outside Australia must not be supplied unless:</span></p><p class="Tablea"><span>(a) the holder of the registration of the product has, on request by the APVMA, given the APVMA, or arranged for the manufacturer of the product to give the APVMA, evidence that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code (an </span><span style="font-weight:bold; font-style:italic">overseas GMP compliance assessment</span><span>); and</span></p><p class="Tablea"><span>(b) the APVMA has assessed the overseas GMP compliance assessment and is satisfied that each step in the manufacture of the product complies with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The formulation type of the chemical product as supplied must be the formulation type entered for the chemical product in the Register in accordance with paragraph</span><span> </span><span>16(da)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="CU_873210"></a><span>6</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The net contents for the chemical product as supplied must be the net contents entered for the chemical product in the Register in accordance with paragraph</span><span> </span><span>16(db)</span></p></td></tr><tr><td style="width:10.08%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><a id="CU_977230"></a><span>7</span></p></td><td style="width:89.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>The identifying information for the holder of the registration, and the nominated agent (if any), for the chemical product as supplied must be the identifying information for the holder and nominated agent (if any) entered for the chemical product in the Register</span></p></td></tr></tbody></table> ``` (3) Items 3 and 4 of the table in subregulation (2) do not apply in relation to a chemical product if: (a) the chemical product is prescribed under subregulation 59(1) for the purposes of section 120A of the Code; or (b) the holder of the registration of the product is an exempt person within the meaning given by regulation 59A, 59B, 59C or 59D.