Final Release of GUI-0080: Foreign Building GMP Compliance

by | Aug 26, 2025 | Canadian Regulatory, Natural Health Products, OTC Drugs

Health Canada has finalized and releases GUI-0080, titled “How to Demonstrate Foreign Building Compliance with Drug Good Manufacturing Practices”. This guidance outlines the expectations and acceptable evidence required to demonstrate that foreign buildings involved in drug fabrication, packaging/labeling, or testing are compliant with Canadian GMP requirements under Division 2 of the Food and Drug Regulations.

Key updates in the final version:

  • Clarity on Evidence Requirements: Clearer details on the types of GMP evidence accepted (e.g., inspection reports from recognized regulatory authorities, on-site audits, etc.)
  • Risk-Based Approach: Emphasis on using a risk-based approach for accessing compliance evidence, especially where mutual recognition agreements (MRAs) don’t exist.
  • Foreign Building Annex (FBA) Guidance: Updated instructions on how to complete and submit the FBA as part of the Drug Establishment Licence (DEL) application or amendment.
  • Inspection Validity Periods: New timelines on the acceptable age of GMP inspection reports “(e.g., generally not older than 3 years at the time of DEL application).
  • Clarified Expectations for MRA vs Non-MRA Jurisdiction: Differentiated guidance based on whether the foreign authority ahs an MRA with Health Canada.
  • Additional Scenarios Included: More examples and clarifications for contract testing labs, repackagers/relabelers, and virtual manufacturers using foreign sites.

A pre-recorded webinar highlighting the key changes will be announced soon through an upcoming DEL bulletin.