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Consultation on the Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements

Warning This content was archived on April 18, 2016.

Archived Content

Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats on the "Contact Us" page.

Notice to the reader: The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period.

This guidance document replaces the outdated 2008 Draft Guidance Document - Drug Master Files (DMFs). The newly revised document provides guidance and direction on the procedures that allows Master File Holders to file Confidential Business Information directly with Health Canada that may be referenced to support an applicant's drug submission or clinical trial application with respect to Quality information.

How to Get Involved

This consultation is open for a 60-day comment period starting February 15, 2016 until April 14, 2016.

Please select and read through the link below titled "consultation document". Once read please submit your comments via email, fax or by mail to:

Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623

Consultation Document

Interested parties are encouraged to provide comments by April 14, 2016.

Reporting to Canadians

A summary of the results from the consultation on the guidance documents will be made available.

If you have any questions, contact us at Bureau of Policy, Science and International Programs.

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