Notice of Publication: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

Drug Establishment Licensing Bulletin 185, July 2, 2025

On this page

• About the publication
• Overview of key changes
• Interim approach for Alternate Sample Retention (ASR) buildings
• Upcoming webinar
• Contact us

About the publication

On July 2, 2025, Health Canada published the following guidance document:

Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

The updated guidance follows a 90-day consultation period that took place February 14 to May 15, 2024. We reviewed the feedback from stakeholders and implemented changes where applicable.

Learn more:

• DEL Bulletin 165

This revised guidance document contains new information to make the document clearer and align with current industry practices. This guidance takes effect immediately.

Overview of key changes

We made changes to the following:

• considerations for managing foreign building campuses during a DEL amendment application
• guidelines for managing alternate sample retention buildings within GUI-0080 (will replace Guidance document alternate sample retention site guidelines (GUI-0014))
• guidance on acceptability of ISO standards for sterilization of packaging material
• guidance on the extra-jurisdictional certificate of compliance (CoC) exchange process
• guidance on the process for risk monitoring and reassessing foreign buildings with non-compliance ratings
• language and formatting updates
• risk-based approach to assigning new evidence required by (NERBY) dates
• risk-based NERBY extension requests
• updates to the list of recommended GMP evidence

Interim approach for Alternate Sample Retention (ASR) buildings

We have updated the application process for Alternate Sample Retention (ASR) buildings. Effective immediately, with the publication of GUI-0080, DEL holders are required to attest to specific criteria when requesting an ASR building instead of submitting GMP evidence to support the compliance of the building. Consult GUI-0080 for the specific criteria.

To submit an application to add or amend an ASR building to your DEL:

• Complete the required sections of the Drug establishment licence application: form and instructions (FRM-0033).
• Provide the required attestations in a cover letter.
• Submit the FRM-0033 and cover letter to el.applications-le@hc-sc.gc.ca.

These instructions apply until a new version of FRM-0033 is released. Once the updated FRM-0033 is available, follow the instructions provided in FRM-0033 to submit an application to add or amend an ASR building to your DEL.

With the inclusion of this new guidance for ASR buildings in GUI-0080, the Guidance document alternate sample retention site guidelines (GUI-0014) will be archived.

Upcoming webinar

We will be sharing a pre-recorded webinar to present the changes in the newly published GUI-0080 after its publication. The link to the webinar will be shared with industry through a forthcoming DEL bulletin.

Questions on the newly published GUI-0080 can be sent to foreign.site-etranger@hc-sc.gc.ca at any time. Questions received prior to the webinar will be considered in the Question-and-Answer section of the pre-recorded webinar.

Contact us

Contact Health Canada's Health Product Inspection and Licensing Division by email:

• Submitting DEL applications: el.applications-le@hc-sc.gc.ca
• General DEL questions: del.questions-leppp@hc-sc.gc.ca
• Foreign building GMP evidence questions: foreign.site-etranger@hc-sc.gc.ca
• Domestic GMP questions: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca
• Active Pharmaceutical Ingredient (API) questions: api.questions-ipa@hc-sc.gc.ca