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Health Canada: Guidance on Master Files Procedures & Administrative Requirements

Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for Master Files".

A key component of this guidance is a definition of Master Files, as well as information about filing requirements, processing, and assessment procedures.


A Master File (MF) is a reference that provides information about specific processes or components used to manufacture, process, or package a drug.


Additionally, the guidance outlines the requirements for registering new Master Files, as well as other Master File transactions such as administrative changes, updates, withdrawals, and closures.


The master file is a voluntary registration filed with Health Canada. The applicant may refer to it in the application for a drug marketing authorization or clinical trial authorization involving pharmaceuticals or biologics, as well as submit non-confidential business information provided by the MF holder. This information is public and/or developed by the applicant for drug submissions, DIN applications, or CTAs.


This guidance applies to all MF holders or applicants that use an MF to support drug submissions and DIN applications for human use or CTAs.


For detailed information on the requirements for Master Files Procedures & Administrative Requirements, click this LINK.

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