Description of the Figure 5: Sample folder structure for DMF Type III - Excipients

Figure 5 displays the sample module 1 to 3 folder structure requirements for a Drug Master File Type III regulatory activity. The Dossier Identifier should be "HC6-24-" followed by a letter and seven numbers.

• Followed by, subfolder:
  • m1
• Sub-subfolders:
  • 1.0 Correspondance
    • 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 1}
    • 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:
  • m3
• Sub-subfolders:
  • 3.1 Table of Contents of Module 3
  • 3.2 Body of Data
    • 3.2.P Drug Product
      • 3.2.P.4 Control of Excipients [Excipient X]
      • 3.2.P.4 Control of Excipients [Excipient Y]
      • 3.2.P.4 Control of Excipients [Excipient Z]
        • 3.2.P.4.1 Specifications
        • 3.2.P.4.2 Analytical Procedures
        • 3.2.P.4.3 Validation of Analytical Procedures
        • 3.2.P.4.4 Justification of Specifications
        • 3.2.P.4.5 Excipients of Human or Animal Origin
        • 3.2.P.4.6 Novel Excipients