﻿<?xml version="1.0" encoding="utf-8"?><Regulation regulation-type="SOR" xml:lang="en" startdate="20110401"><Identification Code="id=&quot;&quot;" hasPreviousVersion="true"><LimsAuthority><Alpha>F-11</Alpha><AuthorityTitle>Financial Administration Act</AuthorityTitle></LimsAuthority><InstrumentNumber>SOR/95-31</InstrumentNumber><RegistrationDate><Date><YYYY>1994</YYYY><MM>12</MM><DD>28</DD></Date></RegistrationDate><ConsolidationDate><Date><YYYY>2013</YYYY><MM>01</MM><DD>28</DD></Date></ConsolidationDate><LastModifiedDate><Date><YYYY>2005</YYYY><MM>6</MM><DD>8</DD></Date></LastModifiedDate><EnablingAuthority Code="id=&quot;&quot;,ea=&quot;&quot;"><XRefExternal reference-type="act">FINANCIAL ADMINISTRATION ACT</XRefExternal></EnablingAuthority><LongTitle Code="id=&quot;&quot;,lt=&quot;&quot;">Authority to Sell Veterinary Drugs Fees Regulations</LongTitle><RegulationMakerOrder><RegulationMaker>P.C.</RegulationMaker><OrderNumber>1994-2170</OrderNumber><Date><YYYY>1994</YYYY><MM>12</MM><DD>28</DD></Date></RegulationMakerOrder></Identification><Order Code="od=&quot;&quot;"><Provision language-align="yes" format-ref="indent-1-0" list-item="no" Code="od=&quot;&quot;,pv=&quot;&quot;,nb=&quot;1&quot;"><Text>His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare and the Treasury Board, pursuant to paragraph 19.1(1)(<Emphasis style="italic">a</Emphasis>)<FootnoteRef idref="footnotea_e">*</FootnoteRef> of the <XRefExternal reference-type="act" link="F-11">Financial Administration Act</XRefExternal>, is pleased hereby to make the annexed <XRefExternal reference-type="regulation">Regulations prescribing the fees to be paid by certain persons or classes of persons on whom the right or privilege to sell a drug is conferred by the Minister of National Health and Welfare by the assignment of an identification number in respect of the drug</XRefExternal>.</Text><Footnote id="footnotea_e" placement="page" status="official"><Label>*</Label><Text>S.C. 1991, c. 24, s. 6</Text></Footnote></Provision></Order><Body><Section Code="se=&quot;1&quot;"><Label>1.</Label><Text><Repealed>[Repealed, SOR/2011-80, s. 2]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_2&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_2&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">INTERPRETATION</TitleText></Heading><Section Code="se=&quot;2&quot;"><Label>2.</Label><Subsection Code="se=&quot;2&quot;,ss=&quot;1&quot;"><Label>(1)</Label><Text>In these Regulations,</Text><Definition generate-in-text="no" Code="se=&quot;2&quot;,ss=&quot;1&quot;,df=&quot;{annual wholesale sales}{ventes en gros annuelles}&quot;"><Text><DefinedTermEn>annual wholesale sales</DefinedTermEn> means the wholesale sales of a drug in the most recently completed fiscal year preceding the day on which a fee is required to be paid under these Regulations in respect of the drug; (<DefinedTermFr>ventes en gros annuelles</DefinedTermFr>)</Text></Definition><Definition generate-in-text="no" Code="se=&quot;2&quot;,ss=&quot;1&quot;,df=&quot;{identification number}{identification numérique}&quot;"><Text><DefinedTermEn>identification number</DefinedTermEn> means a number, preceded by the letters “DIN” or “GP”, that is assigned for a drug in accordance with subsection C.01.014.2(1) of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal>. (<DefinedTermFr>identification numérique</DefinedTermFr>)</Text></Definition></Subsection><Subsection Code="se=&quot;2&quot;,ss=&quot;2&quot;"><Label>(2)</Label><Text>All other words and expressions used in these Regulations have the meaning assigned to them by the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal> or the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal>.</Text></Subsection></Section><Heading Code="ga=&quot;s_3&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_3&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">FEE</TitleText></Heading><Section Code="se=&quot;3&quot;"><Label>3.</Label><Subsection Code="se=&quot;3&quot;,ss=&quot;1&quot;"><Label>(1)</Label><Text>This section applies to a person who has applied for an identification number for a drug of a type set out in column I of the schedule if</Text><Paragraph Code="se=&quot;3&quot;,ss=&quot;1&quot;,p1=&quot;a&quot;"><Label>(<Emphasis style="italic">a</Emphasis>)</Label><Text>an identification number has been assigned for the drug; and</Text></Paragraph><Paragraph Code="se=&quot;3&quot;,ss=&quot;1&quot;,p1=&quot;b&quot;"><Label>(<Emphasis style="italic">b</Emphasis>)</Label><Text>the person has submitted a notification under section C.01.014.3 of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal> that the drug is being sold in Canada.</Text></Paragraph></Subsection><Subsection Code="se=&quot;3&quot;,ss=&quot;2&quot;"><Label>(2)</Label><Text>A person to whom this section applies shall pay, in respect of each drug referred to in subsection (1),</Text><Paragraph Code="se=&quot;3&quot;,ss=&quot;2&quot;,p1=&quot;a&quot;"><Label>(<Emphasis style="italic">a</Emphasis>)</Label><Text>the applicable fee set out in column II of the schedule, where the person’s annual wholesale sales of the drug in Canada are $20,000 or more; or</Text></Paragraph><Paragraph Code="se=&quot;3&quot;,ss=&quot;2&quot;,p1=&quot;b&quot;"><Label>(<Emphasis style="italic">b</Emphasis>)</Label><Text>a fee of $50, where the person’s annual wholesale sales of the drug in Canada are less than $20,000.</Text></Paragraph></Subsection><Subsection Code="se=&quot;3&quot;,ss=&quot;3&quot;"><Label>(3)</Label><Text>A fee referred to in subsection (2) shall be paid annually at the time the notification under section C.01.014.5 of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal> is furnished to the Director, and is in respect of the 12-month period commencing on October 1 in the year in which it is required to be paid.</Text></Subsection><Subsection Code="se=&quot;3&quot;,ss=&quot;4&quot;"><Label>(4)</Label><Text>This section does not apply in respect of a drug if the identification number for the drug has been cancelled pursuant to the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal>.</Text></Subsection></Section><Section Code="se=&quot;4&quot;"><Label>4.</Label><Text><Repealed>[Repealed, SOR/2011-80, s. 3]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Section Code="se=&quot;5&quot;"><Label>5.</Label><Text><Repealed>[Repealed, SOR/2011-80, s. 3]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_6&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_6&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">COMING INTO FORCE</TitleText></Heading><Section Code="se=&quot;6&quot;"><Label>6.</Label><Text>These Regulations come into force on January 1, 1995.</Text></Section></Body><Schedule spanlanguages="no" bilingual="no" Code="sc=&quot;&quot;,nb=&quot;1&quot;"><ScheduleFormHeading><Label>SCHEDULE</Label><OriginatingRef>(Subsections 3(1) and (2))</OriginatingRef></ScheduleFormHeading><TableGroup pointsize="8" topmarginspacing="4"><Caption justification="center" position="over">FEE</Caption><table frame="topbot"><tgroup cols="3"><colspec colname="1" colwidth="0.42*" htmlwidth="14%" /><colspec colname="2" colwidth="2.06*" htmlwidth="69%" /><colspec colname="3" colwidth="0.52*" htmlwidth="17%" /><thead><row height="10pt" topdouble="yes" topmarginspacing="4"><entry colsep="0" rowsep="0" valign="top" id="t6868h0"></entry><entry colsep="0" rowsep="0" valign="top" id="t6868h1">Column I</entry><entry colsep="0" rowsep="0" valign="top" id="t6868h2">Column II</entry></row><row topmarginspacing="6"><entry colsep="0" rowsep="1" id="t6868h3">Item</entry><entry colsep="0" rowsep="1" id="t6868h4" headers="t6868h1">Types of Drugs</entry><entry colsep="0" rowsep="1" id="t6868h5" headers="t6868h2">Fee</entry></row></thead><tbody><row><entry colname="1" colsep="0" rowsep="0" valign="top" headers="t6868h3">1. to 5.</entry><entry colname="2" colsep="0" rowsep="0" valign="top" headers="t6868h1 t6868h4"><Repealed>[Repealed, SOR/2011-80, s. 5]</Repealed></entry><entry align="right" colname="3" colsep="0" rowsep="0" valign="top" headers="t6868h2 t6868h5"></entry></row><row><entry colname="1" colsep="0" rowsep="0" valign="top" headers="t6868h3">6.</entry><entry colname="2" colsep="0" rowsep="0" valign="top" headers="t6868h1 t6868h4">Drugs labelled as being for veterinary use only</entry><entry align="right" colname="3" colsep="0" rowsep="0" valign="top" headers="t6868h2 t6868h5">250</entry></row><row><entry colname="1" colsep="0" rowsep="0" valign="top" headers="t6868h3">7. to 9.</entry><entry colname="2" colsep="0" rowsep="0" valign="top" headers="t6868h1 t6868h4"><Repealed>[Repealed, SOR/2011-80, s. 6]</Repealed></entry><entry align="right" colname="3" colsep="0" rowsep="0" valign="top" headers="t6868h2 t6868h5"></entry></row></tbody></tgroup></table></TableGroup><HistoricalNote><ul><li>SOR/2011-80, ss. 4 to 6.</li></ul></HistoricalNote><a startdate="20060322">Previous Version</a></Schedule></Regulation>