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Drugs and Health Products

Notice: Release of the Final Guidance Document: Master Files (MFs) Procedures and Administrative Requirements

April 28, 2017
Our file number: 17-104593-431

Health Canada is pleased to announce the release of the final Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements. The document replaces the 2008 Draft Guidance Document - Drug Master Files (DMFs).

The Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate jointly developed the guidance document to provide direction on the procedures that allow MF Holders to file quality information that is considered Confidential Business Information directly with Health Canada. This information may be referenced to support an Applicants drug submission, DIN application or clinical trial application for pharmaceuticals, biologics, and radiopharmaceuticals.

The document outlines MF registration requirements and provides details on MF processes and assessment procedures. It is administrative in nature and introduces process changes that are less cumbersome on industry and Health Canada. The fees associated with these new process changes will be announced in the Canada Gazette, along with the implementation date.

Stakeholder comments received on the draft guidance document during the 60 day consultation period (February 15, 2016 to April 14, 2016) were considered in the finalization of this guidance document. A summary of comments received is available upon request to the address below.

Questions or concerns regarding this guidance document should be directed to:

Drug Master File Administration Unit
Therapeutic Products Directorate
Health Products and Food Branch
Finance Building, 2nd Floor
Address Locator: 0201A
101 promenade Tunneys Pasture Driveway
Ottawa, Ontario
K1A 0K9

Email: dmf-fmm@hc-sc.gc.ca
Fax number: 613-941-0825