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<sub_type_vs_toc version="1.1">
  <section number="1" name="Module 1 Administrative and Prescribing Information" content="" header="yes" elementName="m1-sg" />
  <section number="1.0" name="Correspondence" content="" header="yes" elementName="m1-0-correspondence" />
  <section number="1.0.1" name="Cover Letter" content=""  elementName="m1-0-1-cover-letter">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="E" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="E" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="E" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="E" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="E" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="E" />
    <subType code="sub-type-12" displayName="MIV2-N" content="E" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="E" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="E" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="E" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="E" />
    <subType code="sub-type-17" displayName="DMF" content="E" />
    <subType code="sub-type-18" displayName="Baseline" content="E" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="E" />
  </section>
  <section number="1.0.2" name="Note to Evaluator" content=""  elementName="m1-0-2-note-evaluator">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="P" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="P" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="P" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="P" />
  </section>
  <section number="1.0.3" name="Correspondence with HSA" content=""  elementName="m1-0-3-hsa-correspondence">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="P" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="P" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="P" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="P" />
  </section>
  <section number="1.0.4" name="Response to Input Request" content=""  elementName="m1-0-4-response-hsa">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.0.5" name="Meeting Information" content="" elementName="m1-0-5-meeting-info">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="P" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="P" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="P" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="P" />
  </section>
  <section number="1.2" name="Administrative Information" content="" header="yes" elementName="m1-2-admin-info" />
  <section number="1.2.1" name="Application Forms" content=""  elementName="m1-2-1-app-form">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="NV" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.2" name="Checklists" content="" header="yes" elementName="m1-2-2-checklists" />
  <section number="1.2.2.1" name="Appendix 2a Checklist" content=""  elementName="m1-2-2-1-2a">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.2.2" name="Appendix 2b Checklist" content=""  elementName="m1-2-2-2-2b">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="E" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="E" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.2.3" name="Appendix 13a/14a Checklist" content=""  elementName="m1-2-2-3-13a-14a">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="E" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="E" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="W" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="W" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.2.4" name="Appendix 13b/14b Checklist" content=""  elementName="m1-2-2-4-13b-14b">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="E" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.2.5" name="Appendix 13c/14c Checklist" content=""  elementName="m1-2-2-5-13c-14c">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="E" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3" name="Annexes" content="" header="yes" elementName="m1-2-3-annexes" />
  <section number="1.2.3.1" name="Letter of Authorisation from Product Owner" content=""  elementName="m1-2-3-1-loa">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="W" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="W" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3.2" name="Change in Applicant" content="" header="yes" elementName="m1-2-3-2-change-applicant" />
  <section number="1.2.3.2.1" name="Letter of Authorisation from Product Owner to New Registrant" content=""  elementName="m1-2-3-2-1-change-loa">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3.2.2" name="Written Confirmation of Hand-over of Dossier" content=""  elementName="m1-2-3-2-2-confirmation-of-hand-over">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3.3" name="Declaration for Verification or Verification-CECA" content=""  elementName="m1-2-3-3-decl-verif">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3.4" name="Patent Declaration" content="" header="yes" elementName="m1-2-3-4-pat-declaration" />
  <section number="1.2.3.4.1" name="Patent Declaration Form" content=""  elementName="m1-2-3-4-1-pat-decl-form">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.3.4.2" name="Evidence of Authorisation" content=""  elementName="m1-2-3-4-2-pat-evidence-auth">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.4" name="Table of summary of changes" content=""  elementName="m1-2-4-summary-of-changes">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="E" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="E" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="E" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="E" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="E" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="E" />
    <subType code="sub-type-12" displayName="MIV2-N" content="E" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="E" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.2.A" name="Additional Administrative Information" content=""  elementName="m1-2-a-additional-admin-info">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="P" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="P" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="P" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="P" />
  </section>
  <section number="1.3" name="Product Information" content="" header="yes" elementName="m1-3-product-info" />
  <section number="1.3.1" name="Outer Carton Labels (OCL)" content="" header="yes" elementName="m1-3-1-ocl" />
  <section number="1.3.1.1" name="Approved - OCL" content=""  elementName="m1-3-1-1-ocl-approved">
    <subType code="sub-type-1" displayName="NDA" content="XW" />
    <subType code="sub-type-2" displayName="NDA-V" content="XW" />
    <subType code="sub-type-3" displayName="GDA" content="XW" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="XW" />
    <subType code="sub-type-5" displayName="MAV1" content="XW" />
    <subType code="sub-type-6" displayName="MAV1-V" content="XW" />
    <subType code="sub-type-7" displayName="MAV2" content="XW" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="XW" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="XW" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="XW" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="XW" />
    <subType code="sub-type-12" displayName="MIV2-N" content="XW" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="XW" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.1.2" name="Clean Proposed - OCL" content=""  elementName="m1-3-1-2-ocl-clean">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="W" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="W" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.1.3" name="Annotated - OCL" content=""  elementName="m1-3-1-3-ocl-annotated">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.2" name="Inner/Blister Labels (IBL)" content="" header="yes" elementName="m1-3-2-ibl" />
  <section number="1.3.2.1" name="Approved - IBL" content=""  elementName="m1-3-2-1-ibl-approved">
    <subType code="sub-type-1" displayName="NDA" content="XW" />
    <subType code="sub-type-2" displayName="NDA-V" content="XW" />
    <subType code="sub-type-3" displayName="GDA" content="XW" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="XW" />
    <subType code="sub-type-5" displayName="MAV1" content="XW" />
    <subType code="sub-type-6" displayName="MAV1-V" content="XW" />
    <subType code="sub-type-7" displayName="MAV2" content="XW" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="XW" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="XW" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="XW" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="XW" />
    <subType code="sub-type-12" displayName="MIV2-N" content="XW" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="XW" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.2.2" name="Clean Proposed - IBL" content=""  elementName="m1-3-2-2-ibl-clean">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="W" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="W" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.2.3" name="Annotated - IBL" content=""  elementName="m1-3-2-3-ibl-annotated">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.3" name="Package Insert (PI)" content="" header="yes" elementName="m1-3-3-pi" />
  <section number="1.3.3.1" name="Approved - PI" content=""  elementName="m1-3-3-1-pi-approved">
    <subType code="sub-type-1" displayName="NDA" content="XW" />
    <subType code="sub-type-2" displayName="NDA-V" content="XW" />
    <subType code="sub-type-3" displayName="GDA" content="XW" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="XW" />
    <subType code="sub-type-5" displayName="MAV1" content="XW" />
    <subType code="sub-type-6" displayName="MAV1-V" content="XW" />
    <subType code="sub-type-7" displayName="MAV2" content="XW" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="XW" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="XW" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="XW" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="XW" />
    <subType code="sub-type-12" displayName="MIV2-N" content="XW" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="XW" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.3.2" name="Clean Proposed - PI" content=""  elementName="m1-3-3-2-pi-clean">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="W" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="W" />
    <subType code="sub-type-5" displayName="MAV1" content="W" />
    <subType code="sub-type-6" displayName="MAV1-V" content="W" />
    <subType code="sub-type-7" displayName="MAV2" content="W" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="W" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="W" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.3.3" name="Annotated - PI" content=""  elementName="m1-3-3-3-pi-annotated">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="W" />
    <subType code="sub-type-6" displayName="MAV1-V" content="W" />
    <subType code="sub-type-7" displayName="MAV2" content="W" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="W" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="W" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.4" name="Patient Information Leaflet (PIL)" content="" header="yes" elementName="m1-3-4-pil" />
  <section number="1.3.4.1" name="Approved - PIL" content=""  elementName="m1-3-4-1-pil-approved">
    <subType code="sub-type-1" displayName="NDA" content="XW" />
    <subType code="sub-type-2" displayName="NDA-V" content="XW" />
    <subType code="sub-type-3" displayName="GDA" content="XW" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="XW" />
    <subType code="sub-type-5" displayName="MAV1" content="XW" />
    <subType code="sub-type-6" displayName="MAV1-V" content="XW" />
    <subType code="sub-type-7" displayName="MAV2" content="XW" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="XW" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="XW" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="XW" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="XW" />
    <subType code="sub-type-12" displayName="MIV2-N" content="XW" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="XW" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.4.2" name="Clean Proposed - PIL" content=""  elementName="m1-3-4-2-pil-clean">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.4.3" name="Annotated - PIL" content=""  elementName="m1-3-4-3-pil-annotated">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.5" name="Approved Foreign Labelling (SPC/PI/PIL)" content="" header="yes" elementName="m1-3-5-foreign-label" />
  <section number="1.3.5.1" name="SPC/PI/PIL - Reference Agency" content=""  elementName="m1-3-5-1-ref-foreign-label">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="E" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.5.2" name="SPC/PI/PIL - Proof of Approval Agency" content=""  elementName="m1-3-5-2-proof-approval-foreign-label">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="W" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="W" />
    <subType code="sub-type-5" displayName="MAV1" content="W" />
    <subType code="sub-type-6" displayName="MAV1-V" content="W" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.5.3" name="SPC/PI/PIL - Other Agency" content=""  elementName="m1-3-5-3-other-foreign-label">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.3.6" name="Declarations on Foreign Text/Braille" content=""  elementName="m1-3-6-decl-foreign">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.4" name="Information about the Experts" content="" header="yes" elementName="m1-4-info-experts" />
  <section number="1.4.1" name="Quality" content=""  elementName="m1-4-1-quality">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.4.2" name="Nonclinical" content=""  elementName="m1-4-2-nonclinical">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.4.3" name="Clinical" content=""  elementName="m1-4-3-clinical">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.5" name="Master Files and Certificates of Suitability" content="" header="yes" elementName="m1-5-master-files" />
  <section number="1.5.1" name="DMF Acknowledgement Email" content=""  elementName="m1-5-1-dmf-email">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.5.2" name="Letter of Access" content="" header="yes" elementName="m1-5-2-loaccess" />
  <section number="1.5.2.1" name="DMF Letter of Access" content=""  elementName="m1-5-2-1-dmf-loaccess">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.5.2.2" name="PMF Letter of Access" content=""  elementName="m1-5-2-2-pmf-loaccess">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.5.3" name="EMA Certificate for Plasma Master File (PMF)" content=""  elementName="m1-5-3-ema-pmf">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.5.4" name="Certificate of Suitability (CEP)" content=""  elementName="m1-5-4-cep">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.6" name="Environmental Risk Assessment" content="" header="yes" elementName="m1-6-env-risk-assessment" />
  <section number="1.6.1" name="Non-GMO" content=""  elementName="m1-6-1-non-gmo">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.6.2" name="GMO" content=""  elementName="m1-6-2-gmo">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7" name="Good Manufacturing Practice" content="" header="yes" elementName="m1-7-gmp" />
  <section number="1.7.1" name="GMP Certificates or Proof of GMP Compliance" content="" header="yes" elementName="m1-7-1-gmp-certificates" />
  <section number="1.7.1.1" name="Drug Substance Manufacturers" content=""  elementName="m1-7-1-1-drug-substance">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.1.2" name="Finished Pharmaceutical Product (FPP) Manufacturers" content=""  elementName="m1-7-1-2-fpp">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.1.3" name="Batch Releaser" content=""  elementName="m1-7-1-3-batch-releaser">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.2" name="Description of Batch Numbering System" content=""  elementName="m1-7-2-desc-batch-no-sys">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.3" name="HSA GMP Conformity Assessment Application" content="" header="yes" elementName="m1-7-3-gmp-conform-appl" />
  <section number="1.7.3.1" name="Application for GMP Evidence Evaluation" content=""  elementName="m1-7-3-1-gmp-deva">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.3.2" name="Application for Requesting an Overseas GMP Audit" content=""  elementName="m1-7-3-2-gmp-oap">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.7.A" name="Additional GMP Documents" content=""  elementName="m1-7-a-additional-gmp">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.8" name="Information Relating to Pharmacovigilance" content="" header="yes" elementName="m1-8-info-relating-to-pv" />
  <section number="1.8.1" name="Singapore-Specific Annex" content=""  elementName="m1-8-1-ssa">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.8.2" name="Reference RMP" content=""  elementName="m1-8-2-ref-rmp">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.8.3" name="Educational/RMP Materials" content="" header="yes" elementName="m1-8-3-edu-rmp-materials" />
  <section number="1.8.3.1" name="Clean Proposed - Educational/RMP Materials" content=""  elementName="m1-8-3-1-edu-rmp-mat-clean">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="W" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.8.3.2" name="Annotated - Educational/RMP Materials" content=""  elementName="m1-8-3-2-edu-rmp-mat-annotated">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="W" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.8.3.3" name="Finalised Artwork - Educational/RMP Materials" content=""  elementName="m1-8-3-3-edu-rmp-mat-finalised">
    <subType code="sub-type-1" displayName="NDA" content="NV" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="NV" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9" name="Foreign Regulatory Information" content="" header="yes" elementName="m1-9-foreign-reg-info" />
  <section number="1.9.1" name="Registration Status in Other Countries" content=""  elementName="m1-9-1-status">
    <subType code="sub-type-1" displayName="NDA" content="W" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="W" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="W" />
    <subType code="sub-type-6" displayName="MAV1-V" content="W" />
    <subType code="sub-type-7" displayName="MAV2" content="W" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.2" name="Proof of Approval" content="" header="yes" elementName="m1-9-2-proof-approval" />
  <section number="1.9.2.1" name="Proof of Approval from Reference Countries" content=""  elementName="m1-9-2-1-proof-approval-ref">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="W" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="E" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.2.2" name="Proof of Approval from Other Countries" content=""  elementName="m1-9-2-2-proof-approval-other">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.3" name="Data Set Similarities and Differences" content=""  elementName="m1-9-3-data-set-similarities">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.4" name="Foreign Evaluation/Assessment Reports" content=""  elementName="m1-9-4-foreign-evaluation-reports">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.5" name="Appendix 18A Dossier Clarification Supplement" content=""  elementName="m1-9-5-18a">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="NV" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="NV" />
    <subType code="sub-type-5" displayName="MAV1" content="NV" />
    <subType code="sub-type-6" displayName="MAV1-V" content="NV" />
    <subType code="sub-type-7" displayName="MAV2" content="NV" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.9.6" name="Declaration on Rejection, Withdrawal and Deferral" content=""  elementName="m1-9-6-decl-rej-wd-def">
    <subType code="sub-type-1" displayName="NDA" content="E" />
    <subType code="sub-type-2" displayName="NDA-V" content="E" />
    <subType code="sub-type-3" displayName="GDA" content="E" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="E" />
    <subType code="sub-type-5" displayName="MAV1" content="E" />
    <subType code="sub-type-6" displayName="MAV1-V" content="E" />
    <subType code="sub-type-7" displayName="MAV2" content="W" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="NV" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="NV" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="NV" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="NV" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
  <section number="1.A" name="Additional Data" content="" header="yes" elementName="m1-a-additional-data" />
  <section number="1.A.1" name="[DESCRIPTION]" content=""  elementName="m1-a-1-additional-data">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="P" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="P" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="P" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="P" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="P" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="P" />
    <subType code="sub-type-17" displayName="DMF" content="P" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="P" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="P" />
  </section>
  <section number="5.3.6" name="Reports of Postmarketing Experience" content="" header="yes" />
  <section number="node-extension" name="[DESCRIPTION]" content=""  elementName="m5-3-6-reports-of-postmarketing-experience">
    <subType code="sub-type-1" displayName="NDA" content="P" />
    <subType code="sub-type-2" displayName="NDA-V" content="P" />
    <subType code="sub-type-3" displayName="GDA" content="P" />
    <subType code="sub-type-4" displayName="GDA-V/CECA" content="P" />
    <subType code="sub-type-5" displayName="MAV1" content="P" />
    <subType code="sub-type-6" displayName="MAV1-V" content="P" />
    <subType code="sub-type-7" displayName="MAV2" content="P" />
    <subType code="sub-type-8" displayName="MIV1-PI" content="P" />
    <subType code="sub-type-9" displayName="MIV1-PI-V" content="P" />
    <subType code="sub-type-10" displayName="MIV1-CMC" content="NV" />
    <subType code="sub-type-11" displayName="MIV1-CMC-V" content="NV" />
    <subType code="sub-type-12" displayName="MIV2-N" content="P" />
    <subType code="sub-type-13" displayName="MIV2-DnT" content="NV" />
    <subType code="sub-type-14" displayName="PV-EDU/RMP Materials" content="NV" />
    <subType code="sub-type-15" displayName="PV-PBRER/RMP Reports" content="E" />
    <subType code="sub-type-16" displayName="Reg Cond (non-PV)" content="NV" />
    <subType code="sub-type-17" displayName="DMF" content="NV" />
    <subType code="sub-type-18" displayName="Baseline" content="NV" />
    <subType code="sub-type-20" displayName="Transfer of Application" content="XE" />
    <subType code="sub-type-21" displayName="Other Regulatory Activity" content="NV" />
  </section>
</sub_type_vs_toc>