Master Files (MFs) – Procedures and Administrative Requirements

Overview

This guidance document provides an overview of the procedures and administrative requirements for Master Files (MFs). This includes

• registration requirements
• processing and assessment procedures
• filing requirements for transactions such as administrative changes, updates, withdrawals and closures

Who this guide is for

1. Master File Holders
2. Applicants using Master Files to support drug submissions and DIN applications for human use or CTAs
3. Health Canada

In this guide

• 1. Introduction
  • 1.1 Policy objective
  • 1.2 Policy statements
  • 1.3 Scope and application
  • 1.4 Definitions
  • 1.5 Background
• 2. Guidance for Implementation
  • 2.1 Health Canada Master Files
    • 2.1.1 Confidentiality
    • 2.1.2 Registration Requirements
    • 2.1.3 Naming a Master File
    • 2.1.4 Format and Structure of the Master File
      • Converting Master Files from the non-eCTD Format to the eCTD Format
      • Master Files Existing in the Paper Format
    • 2.1.5 Official Language of Correspondence
    • 2.1.6 Letters of Access (LoA)
      • 2.1.6.1 Information to include in the Letter of Access
      • 2.1.6.2 Filing an Letter of Access
      • 2.1.6.3 Letters of Access for Clinical Trials (Pharmaceuticals and Biologics)
    • 2.1.7 Certificates of Suitability to the Monographs of the European Pharmacopeia (CEPs)
    • 2.1.8 Appointment of the Authorized Master File Agent
    • 2.1.9 When to File a New Master File Registration
    • 2.1.10 Master File Fees
  • 2.2 Processing of Master Files
    • 2.2.1 Administrative Holds
    • 2.2.2 Application and File Maintenance Requirements
    • 2.2.3 Master File Performance Standards
  • 2.3 Assessment of Master Files
    • 2.3.1 Solicited Information
    • 2.3.2 Clarification Requests and Letters of Deficiency during MF Assessment in Support of a Submission
      • 2.3.2.1 Clarifications Requests during Master File Assessment in Support of a Clinical Trial Application
    • 2.3.3 Responses to Clarification requests
  • 2.4 Updates to a Registered Master File
    • 2.4.1 Administrative Changes
      • 2.4.1.1 Transfer of Ownership and Substantive Master File Holder Name Changes
      • 2.4.1.2 Non-substantive Changes to Master File Holder Contact Information
      • 2.4.1.3 Change of the Authorized Master File Agent or Authorized Master File Third Party
  • 2.5 Withdrawal of Letters of Access
  • 2.6 Master File Closures
• 3. Contact Information
• 4. References
  • 4.1 Health Canada Documents
  • 4.2 International Council on Harmonisation Guidelines
  • 4.3 International Cooperation on Harmonisatino of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Documents
• 5. Appendices
  • Appendix 1: Relevant Addresses
  • Appendix 2: Sample - Letter of Access
  • Appendix 3: Sample – MF Agent of MF Third Party Authorization Letter
  • Appendix 4: Sample - CEP Attestation Letter
  • Appendix 5 : Sample – BSE/TSE Declaration
  • Appendix 6 : Sample – Statement of Commitment

View complete guide
Download PDF (477 KB, 46 pages)

Details and history

Published: August 08, 2008

Updated: January 1, 2022; February 13, 2019; May 01, 2017.

Consulted: February 15, 2016

Part of topic(s): Guidance on legislation

For assistance

Contact us by email: dmf.enquiries-fmm@canada.ca