October 26, 2021

Volume XI, Number 299

Advertisement
Advertisement

October 25, 2021

Subscribe to Latest Legal News and Analysis

Health Canada Announces New Master File Fees

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.

© 2021 Keller and Heckman LLPNational Law Review, Volume X, Number 100
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

...

202-434-4100
Advertisement
Advertisement
Advertisement