Upcoming Publication of How to Demonstrate Foreign Building Compliance with Drug GMPs GUI-0080

Posted Date: 2-July-2025

Publication of a New Bulletin: Ending Foreign Site Reference Number Process & Foreign Warehouses

 

Health Canada has finally updated its guidance document, How to demonstrate foreign building compliance with drug good manufacturing practices: GUI-0080, to improve predictability and transparency for the drug industry. This guidance document was consulted upon from February 14 to May 15, 2024.  The final guide is expected to be published on July 2, 2025. A pre-recorded webinar detailing the key changes will be released by Health Canada soon, with a link to be provided through the pending DEL Bulletin publication. Cosmetics Alliance will notify members once GUI-0080 is officially published along with the details to the pre-recorded webinar.