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How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Submitting DEL amendment applications

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For a brief overview of the application types described in this section, refer to Application types and processes.

General information for submitting DEL amendment applications

This section outlines the general information that should be submitted for any DEL application.

For instructions on how to submit your application, consult:

These instructions apply to all applications described in this section.

You must inform Health Canada if:

To determine next steps, email us at foreign.site-etranger@hc-sc.gc.ca.

If the foreign building that is part of your application is responsible for activities on products in shortage, consult:

Cover letter

Including a cover letter is strongly recommended when submitting all DEL applications. It should contain information that will help us review your application. Include the following information, where applicable:

For more information on what to include on your cover letter, consult:

FRM-0033

Make sure your application contains complete information in all applicable sections of the most recent and up-to-date version of FRM-0033.

For a copy of the recent FRM-0033 template and instructions on how to complete the form, consult:

Submitting an amendment to the FB annex

An application must be submitted to amend the foreign building (FB) annex (adding a new foreign building or renewing or amending an existing foreign building).

Include the cover letter and FRM-0033. Your application may need to be accompanied by supporting GMP evidence as well.

The rest of this section describes the type of supporting GMP evidence you can submit and how to submit it. The service standard for your application depends on the type of supporting evidence and whether it has been previously reviewed by Health Canada.

For more information on application service standards, consult:

Determining the type of GMP evidence

The type of GMP evidence needed to demonstrate the GMP compliance of foreign buildings is based on where the foreign building is located and whether it's covered by an MRA (Table 2). Some administrative amendment applications (for example, change in name or address of a foreign building or change to activities, categories or dosage forms) may require GMP evidence as well.

To determine when your administrative amendment application requires GMP evidence, refer to Submitting an amendment for changes related to a foreign building on the DEL.

Health Canada will evaluate the most recent GMP evidence available for the foreign building (recent evidence is within the last 3 years). In certain circumstances, we may consider a different validity period for GMP evidence. The GMP evidence must cover the scope of the activities, categories and dosage forms listed on your FRM-0033.

If you are not submitting the most recent GMP evidence (for example, evidence is within 3 years but is not the most recent) to support your application, you must indicate this and explain why in your cover letter.

Table 2: Recommended GMP evidence based on foreign building location and coverage by an MRA
MRA coverage Foreign building located in an MRA country Foreign building not located in an MRA country
Activities covered by an MRA (inspected by MRA partner) CoC to support compliance of foreign building EJ CoC to support compliance of foreign building
Activities not covered by an MRA (not inspected by MRA partner) Full GMP evidence to support compliance of foreign building Full GMP evidence to support compliance of foreign building

Note: To ensure service standards are met for application streams, Health Canada will only consider and review 1 type of GMP evidence for each foreign building included in your DEL application. If you need to submit a new type of GMP evidence, we will consider this as a change in scope of the current application and will require a new application.

Examples of a change in scope include a request:

For more information on change in scope of applications, consult:

CoC to support compliance of foreign building

For an amendment to your FB annex where the foreign building is in an MRA country and the activities, drug categories and dosage forms are covered by the MRA, the supporting GMP evidence should be a CoC. You should:

The cover letter and FRM-0033 is Health Canada's prompt to request a CoC from the applicable MRA partner.

Keep a copy of the CoC at the domestic building (refer to Maintaining GMP evidence onsite). We exchange CoCs with our MRA partners only and will not send a copy of the CoC to importers.

Before submitting an application indicating a CoC as the supporting GMP evidence, make sure the CoC covers the requested activities, drug categories and dosage forms on FRM-0033.

EJ CoC to support compliance of a foreign building

For an amendment to your FB annex where the foreign building is located in a non-MRA country and was inspected by an MRA partner with whom Health Canada exchanges EJ CoCs, you should:

The cover letter and FRM-0033 is Health Canada's prompt to request an EJ CoC from the applicable MRA partner. If the cover letter and FRM-0033 do not indicate these details, we will not request an EJ CoC from the MRA partner. We will assume that full GMP evidence will be submitted and route the application to the appropriate review stream.

If an EJ CoC becomes available while the application has already been routed to the full GMP evidence review stream or if you incorrectly submitted your application with EJ CoC as supporting evidence, you will be asked to withdraw the existing application. You will need to submit a new application under the appropriate review stream.

Keep a copy of the EJ CoC at the domestic building (refer to Maintaining GMP evidence onsite).

When the supporting evidence is an EJ CoC, the EJ CoC must:

It's the importer's responsibility to submit a renewal application by the foreign building's NERBY date.

Full GMP evidence to support compliance of foreign building

For an amendment to your FB annex where the foreign building or its activities, categories or dosage forms are not covered by the MRA or not inspected by an MRA partner, you should submit full GMP evidence to demonstrate GMP compliance of a foreign building. This includes:

The documents you need to submit in the GMP evidence package must meet specific requirements. To learn more about these requirements, refer to Recommended full GMP evidence package.

How to submit the full GMP evidence package

Health Canada strongly recommends that the importer submit GMP evidence when filing the application. Email the evidence to the Drug Establishment Licensing Unit at el.applications-le@hc-sc.gc.ca before you receive the DEL screening completion notice.

If you are not able to submit some of the recommended evidence, we will accept the evidence directly from the foreign building or by an organization on behalf of the foreign building. The evidence must be submitted:

GMP evidence submitted separate from the application must be submitted before you receive the DEL screening completion notice. If GMP evidence is not submitted before we send out the DEL screening completion notice, we will send a GMP screening deficiency notice. This will count as 1 of your 2 opportunities to meet the GMP evidence requirements.

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

To help with the submission process and review of the GMP evidence, we recommend that:

For responses to GMP screening deficiency notices, the DEL holder or the foreign building should submit the requested information to foreign.site-etranger@hc-sc.gc.ca and clearly reference the application number and DEL number.

Information submitted without referencing an application number or sent to the incorrect email address will not be accepted and may lead to the application being rejected in full or in part. The importer is responsible for making sure that we receive a complete response to a deficiency notice.

Applications are subject to the pause-the-clock policy and the clock will be paused when a deficiency is identified.

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

A risk-based NERBY extension request

Importers may request an extension to a foreign building's NERBY date under certain scenarios. The request for a NERBY extension should be submitted as an application using FRM-0033. NERBY extensions help provide flexibility in scenarios where updated GMP evidence is not available at the time of submission.

If a foreign building on your licence has a NERBY date that is approaching but there is no new GMP evidence, you may ask for a risk-based extension of the NERBY date if an:

For Health Canada to consider extending the NERBY date, you must complete FRM-0559: NERBY extension request form and submit it with your application (FRM-0033 and cover letter). FRM-0559 requests additional information, which we use to determine if a risk-based NERBY extension can be granted.

Email foreign.site-etranger@hc-sc.gc.ca for a copy of the most recent version of FRM-0559.

When evaluating a risk-based NERBY extension, we consider:

For a description of the NERBY extension assessment and outcomes, consult:

Submitting an amendment to the API FB annex

How to submit

To add a foreign building to your API FB annex that fabricates, packages/labels or tests non-sterile APIs, non-sterile atypical APIs or non-sterile API intermediates, email the application to el.applications-le@hc-sc.gc.ca.

Your application should include:

You do not need to submit GMP evidence with your application. However, you must ensure foreign buildings on the API FB annex have an inspection report that demonstrates their compliance with Division 2 of the regulations. The inspection report you indicate in Table A must meet the requirements outlined in Inspection report.

Maintain and review a copy of the evidence that is referenced in Table A onsite at the domestic building.

An application is not required to maintain foreign buildings on the API FB annex as these buildings are not assigned a NERBY date.

For application considerations of a non-compliant site on your API FB annex, refer to Reassessing non-compliant ratings.

Considerations for atypical APIs

Importers of listed atypical APIs and finished dosage form (FDF) containing listed atypical APIs that are fabricated, packaged/labelled and tested can reference standards other than GMP in Table A.

For a copy of the most recent version of the Table A form and instructions, email the Drug Establishment Licensing Unit at del.questions-leppp@hc-sc.gc.ca.

Cases where antioxidants, preservatives or stabilizers are added to an atypical API to maintain the efficacy of the atypical API or for safety reasons would still be considered an atypical API.

Note: Before sale, each lot or batch of the atypical API must be tested against and comply with the specifications for that API. If there is a pharmacopeial standard for the atypical API (Schedule B, Food and Drugs Act), the API should be fabricated and tested against that standard.

Health Canada assessment

Health Canada will assess your application to make sure it's complete. As no GMP evidence needs to be submitted, deficiencies related to GMP evidence will not be sent for API FB annex applications. However, a deficiency notice will be sent if the Table A form is incomplete.

To learn more about other types of deficiencies related to the Table A form, consult:

During a domestic inspection, a Health Canada inspector will ensure importers have appropriate processes and oversight of API sites that are part of the supply chain. We use a risk-based approach to select foreign buildings on the API FB annex to review when confirming the availability of GMP evidence. This includes taking into consideration a number of factors, such as type of GMP evidence available (corporate audit or inspection by qualified or regulatory authority, or CoC/EJ CoC) and the foreign building's compliance history. At any time, we may also ask for evidence to demonstrate the foreign building's GMP compliance.

To help with verification, Table A should list all sites included on the importer's API FB annex. This includes referencing the most recent GMP evidence available for each foreign building.

For more information on maintaining evidence for foreign buildings on the API FB annex, refer to Maintaining GMP evidence onsite.

Submitting an amendment to the ASR annex

To add a foreign building responsible for retaining samples to your ASR annex or to retain samples for a new product at an existing foreign building on the ASR annex, email the application to el.applications-le@hc-sc.gc.ca. The application should include:

You do not need to submit GMP evidence with your application.

For a foreign building to be eligible on the ASR annex, the samples that are retained must meet 1 of the following criteria:

You must attest that the retention sample meets at least 1 of these criteria in FRM-0033.

To allow a foreign building to be eligible on the ASR annex, as the importer or distributor (depending on who is responsible for maintaining retention samples), you must also attest in FRM-0033 that:

Submitting an amendment for changes for a foreign building on the DEL

Change in foreign building name or address

To notify us of changes to the name or address of a foreign building on your DEL, email the application to el.applications-le@hc-sc.gc.ca. Include in your application:

For foreign buildings located in a non-MRA country or foreign buildings in an MRA country not inspected by an MRA partner, the name and address should be consistent with the foreign building's site master file (SMF) (also known as a site reference file (SRF)). Submit the most recent SMF with your application.

For foreign buildings in an MRA country and inspected by an MRA partner, the name and address should be consistent with the name and address registered with the MRA partner and displayed on the CoC. If an updated CoC reflecting the new name or address is not available, indicate the change in your cover letter so Health Canada can confirm with the MRA partner.

You must submit your DEL amendment application with updated GMP evidence if a foreign building name or address changes due to a change in the physical location of the foreign building. The supporting GMP evidence must cover the new location of the foreign building whether the foreign building is in a non-MRA or an MRA country.

To determine what supporting GMP evidence should be submitted if a change in physical address occurred, refer to Submitting an amendment to the FB annex.

Change in licensable activities at a foreign building

To amend activities, categories or dosage forms of a foreign building on your FB annex, you must email the application to el.applications-le@hc-sc.gc.ca. Include in your application:

You may reference previously submitted GMP evidence to support your amendment. In this case, indicate in your cover letter that you are using previously submitted evidence to support the amendment. Make sure the referenced evidence is valid (within the last 3 years or a period considered acceptable by Health Canada) and supports any new licensable activities, categories and dosage forms. To determine what supporting GMP evidence should be submitted, refer to Submitting an amendment to the FB annex.

Note: If you are submitting an application for new licensable activities, categories or dosage forms at a foreign building already on your licence, you cannot import the applicable products until you receive a supplement to the FB annex or confirmation that your DEL has been updated. If a supplement to the FB annex or DEL was issued, it must authorize the new activities, categories and sterility statuses of dosage forms that have been added on your licence.

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2026-04-17