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Health Canada Announces New Master File Fees
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Health Canada announced that fees related to Master Files (MFs)—which provide confidential information about processes or components used in the manufacturing, processing, or packaging of a drug—will increase by 2% as of April 1, 2020. The new Master File fees are:
- New Master File Registration - $1273.00 Canadian Dollar (CAD)
- Update - $552.00 CAD
- Letter of Authorization - $ 180.00 CAD
Forms for filing MFs can be found on Health Canada’s website. A revised guidance document on Master Files procedures and administrative requirements was published by Health Canada in 2019 and is available here.