﻿<?xml version="1.0" encoding="utf-8"?><Regulation gazette-part="II" 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/95-424</InstrumentNumber><RegistrationDate><Date><YYYY>1995</YYYY><MM>08</MM><DD>30</DD></Date></RegistrationDate><LastAmendedDate><Date><YYYY>6</YYYY><MM>09</MM><DD>1195</DD></Date></LastAmendedDate><ConsolidationDate><Date><YYYY>2013</YYYY><MM>01</MM><DD>28</DD></Date></ConsolidationDate><LastModifiedDate><Date><YYYY>2011</YYYY><MM>3</MM><DD>24</DD></Date></LastModifiedDate><EnablingAuthority Code="id=&quot;&quot;,ea=&quot;&quot;"><XRefExternal reference-type="act">FINANCIAL ADMINISTRATION ACT</XRefExternal></EnablingAuthority><ShortTitle Code="id=&quot;&quot;,st=&quot;&quot;">Drug Evaluation Fees Regulations</ShortTitle><LongTitle Code="id=&quot;&quot;,lt=&quot;&quot;">Regulations Prescribing the Fees to be Paid for a Drug Submission Evaluation Service Provided by or on Behalf of Her Majesty in Right of Canada</LongTitle><RegulationMakerOrder><RegulationMaker>P.C.</RegulationMaker><OrderNumber>1995-1444</OrderNumber><Date><YYYY>1995</YYYY><MM>08</MM><DD>30</DD></Date></RegulationMakerOrder></Identification><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Body><Heading Code="ga=&quot;s_1&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_1&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">SHORT TITLE</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;1&quot;"><Label>1.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed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><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;2&quot;"><Label>2.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></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;">APPLICATION</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;3&quot;"><Label>3.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_4&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_4&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">NEW DRUG SUBMISSION</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;4&quot;"><Label>4.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_5&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_5&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">SUPPLEMENT TO A NEW DRUG SUBMISSION</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;5&quot;"><Label>5.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</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;">ABBREVIATED NEW DRUG SUBMISSION AND SUPPLEMENT TO AN ABBREVIATED NEW DRUG SUBMISSION</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;6&quot;"><Label>6.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_7&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_7&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">DRUG IDENTIFICATION NUMBER (DIN)</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;7&quot;"><Label>7.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_8&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_8&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">NUMBERED CERTIFICATE OF REGISTRATION (GP)</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;8&quot;"><Label>8.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_9&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_9&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">SUBMISSION, SUPPLEMENT OR APPLICATION FILED ON OR AFTER SEPTEMBER 1, 1996</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;9&quot;"><Label>9.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_10&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_10&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">SUBMISSION, SUPPLEMENT OR APPLICATION FILED BEFORE SEPTEMBER 1, 1996</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;10&quot;"><Label>10.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Section Code="se=&quot;11&quot;"><Label>11.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_12&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_12&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">REDUCTION OF FEES</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;12&quot;"><Label>12.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section><Heading Code="ga=&quot;s_13&quot;,h1=&quot;&quot;" level="1"><TitleText Code="ga=&quot;s_13&quot;,h1=&quot;&quot;,t1=&quot;&quot;,nb=&quot;1&quot;">COMING INTO FORCE</TitleText></Heading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><Section Code="se=&quot;13&quot;"><Label>13.</Label><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text><a startdate="20060322">Previous Version</a></Section></Body><Schedule bilingual="no" spanlanguages="no" Code="sc=&quot;&quot;,nb=&quot;1&quot;"><ScheduleFormHeading><Label>SCHEDULE</Label><OriginatingRef>(Sections 4 to 8 and 11)</OriginatingRef><TitleText>FEES PAYABLE FOR DRUG EVALUATION SERVICE</TitleText></ScheduleFormHeading><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed><a startdate="20060322">Previous Version</a></Schedule><Order Code="od=&quot;&quot;"><Provision Code="od=&quot;&quot;,pv=&quot;&quot;,nb=&quot;1&quot;"><Text><Repealed>[Repealed, SOR/2011-79, s. 54]</Repealed></Text></Provision></Order></Regulation>