Description of the Figure F-2: MF Type II - Container Closure Systems and Components

Figure F-2 - displays the sample module 1 to 3 folder structure requirements for a Master File Type II regulatory activity.

The Dossier Identifier should be “f” followed by seven numbers.

• Followed by, subfolder:
  • m1
• 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 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
  • 1.3 Product Information
  • 1.3.6 Certified Product Information Document
• Subfolder for option^{Footnote 1}:
  • m3
• Sub-subfolders for option^{Footnote 1}:
  • 3.1 Table of Contents of Module 3
  • 3.2 Body of Data
  • 3.2.P Drug Product
  • 3.2.P.7 Container Closure System
    • Component X
    • Component Y
    • Component Z
• Subfolder for option^{Footnote 2}:
  • m3
• Sub-subfolders for option^{Footnote 2}:
  • 3.1 Table of Contents of Module 3
  • 3.2 Body of Data
  • 3.2.P Drug Product
  • 3.2.P.1 Description and Composition of the Drug Product
  • 3.2.P.3 Manufacture
  • 3.2.P.3.1 Manufacturer(s)
  • 3.2.P.3.3 Description of Manufacturing Process and Process Controls
  • 3.2.P.3.5 Process Validation and/or Evaluation
  • 3.2.P.5 Control of Drug Product
  • 3.2.P.5.1 Specification(s)
  • 3.2.P.5.2 Analytical Procedures
  • 3.2.P.7 Container Closure System
    • Component X
    • Component Y
    • Component Z

Two options are recommended for providing multiple components in the M3 folder.