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

Important notice

The Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements was revised on January 2, 2019 with the purpose of increasing clarity with respect to the filing requirements for Master Files. No policy changes were made in this revision.

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

View complete guide
Download PDF (206 KB, 38 pages)

Details and history

Published: August 08, 2008

Updated: February 13, 2019; May 01, 2017.

Consulted: February 15, 2016

Part of topic(s): Guidance on legislation

For assistance

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

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