Description of the Figure 6: Sample Folder Structure for DMF Type IV – Drug Product

Figure 6 displays the sample module 1 to 3 folder structure requirements for a Drug Master File Type IV regulatory activity. The Dossier Identifier should be "HC6-24-" followed by a letter and seven numbers.

• Followed by, subfolder:
  • m1^{Footnote 1}
• Sub-Subfolders:
  • 1.0 Correspondence
    • 1.0.1 Cover Letter
    • 1.0.3 Copy of Health Canada Issued Correspondence
    • 1.0.4 Health Canada Solicited Information
    • 1.0.7 General Note to Reviewer
  • 1.1 Table of Contents
  • 1.2 Administrative Information
    • 1.2.1 Application Form
    • 1.2.2 Fee Forms^{Footnote 2}
    • 1.2.3 Certification and Attestation Forms
    • 1.2.5 Compliance and Site Information
    • 1.2.6 Authorization for Sharing Information
    • 1.2.7 International Information
    • 1.2.9 Other Administration Information
  • 1.3 Product Information
    • 1.3.6 Certified Product Information Document
• Subfolder:
  • m2
• Sub-subfolder:
  • 2.3 Quality Overall Summary^{Footnote 3}
• Subfolder:
  • m3
• Sub-subfolders:
  • 3.1 Table of Contents of Module 3
  • 3.2 Body of Data
    • 3.2.P Drug Product (AP)
      • 3.2.P.1 Description and Composition of Drug Product
      • 3.2.P.2 Pharmaceutical Development
      • 3.2.P.3 Manufacture
      • 3.2.P.4 Control of Excipients
      • 3.2.P.5 Control do Drug Product
      • 3.2.P.6 Reference Standards or Materials
      • 3.2.P.7 Container Closer System
      • 3.2.P.8 Stability
    • 3.2.P Drug Product (RP)
      • 3.2.P.1 Description and Composition of Drug Product
      • 3.2.P.2 Pharmaceutical Development
      • 3.2.P.3 Manufacture
      • 3.2.P.4 Control of Excipients
      • 3.2.P.5 Control do Drug Product
    • 3.2.A Appendices^{Footnote 1}
      • 3.2.A.1 Facilities and Equipment
      • 3.2.A.2 Adventitious Agents Safety Evaluation
      • 3.2.A.3 Excipients
    • 3.2.R Regional Information^{Footnote 1}
      • 3.2.R.1 Production Documentation