Master Files (MFs) – Procedures and Administrative Requirements
Related guides and help
- Notice: Update to the Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements Effective January 1, 2022
- Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format
- Master File Application Form
- Master File Application Fee Form
- How to Pay Fees to Health Products and Food Branch
- Fees for Master Files for human drugs
Related acts and regulations
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
- Master File Holders
- Applicants using Master Files to support drug submissions and DIN applications for human use or CTAs
- Health Canada
In this guide
- 1. Introduction
- 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
- 2.1.5 Official Language of Correspondence
- 2.1.6 Letters of Access (LoA)
- 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
- 2.3 Assessment of Master Files
- 2.4 Updates to a Registered Master File
- 2.5 Withdrawal of Letters of Access
- 2.6 Master File Closures
- 2.1 Health Canada Master Files
- 3. Contact Information
- 4. References
- 5. Appendices
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
Report a problem or mistake on this page
- Date modified: