Description of the figure F-4: MF Type IV - Drug Product

Figure F-4 displays the sample module 1 to 3 folder structure requirements for a Master File Type IV 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
  • 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:
  • m2
• Sub-subfolders:
  • 2.3 Quality Overall Summary
• Subfolder:
  • m3
• Sub-subfolders:
  • 3.3.1 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 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 1
  • 3.2.R.1 Production Documentation