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This guidance document replaces the outdated 2008 Draft Guidance Document - Drug Master Files (DMFs).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.
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 Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott St.
Interested parties are encouraged to provide comments by April 14, 2016.
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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