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Drugs and Health Products

Description of the Figure F-1: MF Type I - Drug Substance

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

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

  • Followed by, subfolder:
    • m11
  • 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 Forms2
    • 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
  • Subfolder:
    • m2
  • Sub-subfolder:
    • 2.3 Quality Overall Summary3
  • Subfolder:
    • m3
  • Sub-subfolders:
    • 3.1 Table of Contents of Module 3
    • 3.2 Body of Data
    • 3.2.S Drug Substance (AP)
    • 3.2.S.1 General Information
    • 3.2.S.2 Manufacture
    • 3.2.S.3 Characterisation
    • 3.2.S.4 Control of Drug Substance
    • 3.2.S.5 Reference Standards or Materials
    • 3.2.S.6 Container Closure System
    • 3.2.S.7 Stability
    • 3.2.S Drug Substance (RP)
    • 3.2.S.2 Manufacture
    • 3.2.S.3 Characterisation
    • 3.2.S.4 Control of Drug Substance
    • 3.2.A Appendices1
    • 3.2.A.1 Facilities and Equipment
    • 3.2.A.2 Adventitious Agents Safety Evaluation

(AP) or (RP) should be used in the subfolder names to identify if the folder is Applications Part or Restricted Part.