Description of the figure F-3: MF Type III - Excipients

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

The Dossier Identifier should be "f" followed by 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 Forms1
  • 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:
  • 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