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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:
- 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:
- Sub-subfolder:
- 2.3 Quality Overall Summary3
- Subfolder:
- 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.