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How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Listing foreign buildings on your DEL

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Drug establishment licence annexes

All Canadian drug establishments must hold an active drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug. This is required under Part C, Division 1A of the Food and Drug Regulations (FDR).

For more information on how to comply with Part C, Division 1A of the FDR, consult:

The following sections describe the 3 different annexes where foreign buildings can be listed on a DEL. The type of annex where a foreign building is listed depends on the activities and the drug category associated with the foreign building:

1. Foreign building annex (FB annex)

This annex applies to foreign buildings that:

For guidance on adding foreign buildings to your FB annex, refer to Submitting an amendment to the FB annex.

Foreign buildings subcontracted to perform these activities must also be listed on the FB annex of your DEL:

Note: Health Canada considers the fabrication process of an FDF to include the release testing of the API as well as the final fabrication of the FDF. If the FDF fabricator performs the release testing of the API for use in the FDF fabrication:

As well, in scenarios where the FDF fabricator is responsible for the full API release testing, the API fabricator does not need to be listed on the FB annex for release testing of the API.

2. Active pharmaceutical ingredient foreign building annex (API FB annex)

This annex applies to foreign buildings that:

For guidance on adding foreign buildings to your API FB annex, refer to Submitting an amendment to the API FB annex.

3. Alternate sample retention (ASR) annex

This annex applies to distributors and importers that retain samples of specific products at buildings outside of Canada. If the distributor and importer are different companies, only 1 of the 2 companies needs to list ASR buildings on their ASR annex depending on the responsibilities outlined in the quality agreement between those 2 companies.

The requirement for retaining samples:

For guidance on adding a foreign building to your ASR annex, refer to Submitting an amendment to the ASR annex.

Mutual recognition agreements

Canada is a participant to several mutual recognition agreements (MRAs) covering drug good manufacturing practices (GMP) compliance programs. MRAs are created to ensure that the regulatory frameworks in place in each partner's jurisdiction are equivalent. Health Canada will consider a valid certificate of compliance (CoC) as evidence to support the GMP compliance of a foreign building located in an MRA country. We will exchange the CoC with our MRA partners only.

For when to use a CoC as GMP evidence to support an application for a foreign building located in an MRA country, refer to CoC to support compliance of foreign building.

APIs are temporarily excluded from certain MRAs, as not all MRA partners have an API GMP compliance program that has been assessed. We will be updating the list of countries with the updated MRAs (including APIs) as the scope of MRAs evolve.

Learn more about Health Canada's MRAs, including the specific MRA partners and their operational scope, consult mutual recognition agreements webpage.

Note: As per C.01A.015 of the FDR, you must notify us of any changes to a building's compliance status, permit, licence or other authorization issued by the regulatory authority that recognized the building.

For more information on C.01A.015 notifications, consult:

MRA extra-jurisdictional inspection outcomes

We have expanded the scope of certain MRAs to include the exchange of CoCs for GMP inspections of foreign buildings conducted by the MRA partner outside their jurisdiction (non-MRA countries). The expanded scope will:

We exchange extra-jurisdictional (EJ) CoCs directly with the MRA partner if the CoC is within the:

We exchange EJ CoCs with certain MRA partners, including:

For details on using an EJ CoC as GMP evidence to support an application for a foreign building located in a non-MRA country, refer to EJ CoC to support compliance of foreign building.

If the last Health Canada assessment of a foreign building was assigned a non-compliant rating, an EJ CoC cannot be submitted as GMP evidence to overcome the non-compliant rating. For the requirements to reassess a non-compliant rating, refer to Reassessing non-compliant ratings.

Note that remote and hybrid inspections are outside the operational scope of the MRA and are not eligible for the exchange of EJ CoCs. In these cases, we may consider inspection reports based on remote assessments using a risk-based approach. For information on when you may submit GMP evidence based on remote assessments, refer to Inspection report.

New evidence required by date

A "new evidence required by" (NERBY) date is the date when updated GMP evidence must be submitted to Health Canada to renew a foreign building on the licence. The NERBY date acts as a checkpoint for us to verify the continued compliance of a foreign building that supplies products to Canada.

A NERBY date is assigned to foreign buildings based on location, the type of supporting GMP evidence reviewed and the type of annex on which the foreign building is listed (Table 1).

Table 1: Summary of when NERBY dates are assigned
DEL annex Location of foreign building NERBY date assigned (yes or no)
FB annex Located in an MRA country (for activities or drug categories covered by the MRA) No
FB annex Located in an MRA country (for activities or drug categories not covered by the MRA or not inspected by the MRA partner)
or
Not located in an MRA country		 Yes
API FB annex Located outside of Canada No
ASR annex Located outside of Canada No

A NERBY date is assigned to a foreign building using a risk-based approach. The typical NERBY date is 4 years from the start date of the inspection by a regulatory or qualified authority, qualified body or a Health Canada foreign onsite inspection.

For example, if the start date of an inspection is January 14, 2023, the typical NERBY date will be January 14, 2027.

However, we may assign a shorter or longer NERBY date based on the risk profile of the foreign building.

When assigning a NERBY date to a foreign building, we consider the:

If the foreign building on the FB annex of your licence is assigned a NERBY date, you must submit an application along with updated supporting GMP evidence to renew the NERBY date. You must do this before the assigned NERBY date to maintain the foreign building on the FB annex of your DEL.

If you submit an amendment application before the NERBY date, the foreign building will continue to be listed on the FB annex of your DEL while we review the application.

For more information, refer to Submitting an amendment to the FB annex.

We may extend a previously assigned NERBY date based on the circumstances described in a risk-based NERBY extension request.

If Health Canada becomes aware that the foreign building has GMP concerns, we may request new evidence from you before the NERBY date. Once we evaluate this new evidence, we may change the previously assigned NERBY date or propose other compliance and enforcement actions.

The foreign building may be removed from the FB annex if the NERBY date has expired and:

To learn more about types of deficiencies and the pause-the clock policy, consult:

If a NERBY date is not assigned to a foreign building (refer to Table 1), you do not have to submit an application with new GMP evidence. However, you must ensure that any foreign building on your licence continues to comply with the GMP requirements.

Health Canada assessment outcomes

Health Canada will complete an assessment of a foreign building based on the supporting GMP evidence.

We will then assign a compliance rating:

Terms and conditions (T&Cs) may be added to your DEL if other factors require additional oversight, such as:

For more information on T&Cs, refer to Compliance with terms and conditions.

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2025-07-02