How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Application types and processes
This section contains diagrams that give an overview of the application types described in this guidance document. We have also provided a link to the appropriate section outlining the type of documentation that must be provided to support your application.
Figure 1 - Text description
The flowchart outlines the process for a foreign building located in a country with a mutual recognition agreement (MRA) for activities covered by the MRA listed on the foreign building annex of a drug establishment licence (DEL). The foreign building is added to the FB annex for the activities of fabricate, package/label or test finished dosage form (FDF), FDF intermediates and sterile active pharmaceutical ingredients (APIs) or release testing of sterile and/or non-sterile APIs and atypical APIs.
You must apply to add this type of foreign building to a drug establishment licence. For information on the application process, refer to CoC to support compliance of foreign building. You do not need to apply to renew this type of foreign building.
Figure 2 - Text description
The flowchart outlines the process for a foreign building located in a non-MRA country for activities covered by the MRA that should be listed on the foreign building annex of a DEL. The foreign building is added to the FB annex for the activities of fabricate, package/label or test FDF, FDF intermediates or sterile APIs, or release testing of sterile and/or non-sterile APIs and atypical APIs.
You must apply to add or renew this type of foreign building to a DEL. For information, refer to EJ CoC to support compliance of the foreign building.
Figure 3 - Text description
The flowchart outlines the process for activities not covered by an MRA (inspected by an MRA partner) that should be listed on the foreign building annex of a DEL. This process also applies to foreign buildings located in both a non-MRA and MRA country. The foreign building is added to the FB annex for the activities of fabricate, package/label or test FDF, FDF intermediates, sterile APIs or sterile atypical APIs, or release testing of sterile or non-sterile APIs and atypical APIs.
You must apply to add or renew this type of foreign building to a DEL. For information on the application process, refer to Full GMP evidence to support compliance of foreign building.
Figure 4 - Text description
The flowchart outlines the process for renewing a foreign building located in an MRA country for activities not covered by the MRA (not inspected by an MRA partner). The process also applies to foreign buildings located in a non-MRA country that are listed on the foreign building annex of a DEL. The foreign building is added to the FB annex for the activities of fabricate, package/label or test FDF, FDF intermediates or sterile APIs, or release testing of sterile or non-sterile APIs and atypical APIs.
If there are no supporting GMP evidence options for the foreign building, you may submit a request to extend the NERBY date. For information, refer to NERBY extension request as supporting evidence.
Figure 5 - Text description
The flowchart outlines the process for a foreign building listed on the API foreign building annex of a DEL, whether it be located in an MRA country or a non-MRA country. The foreign building is added to the API FB annex for the activities of fabricate, package/label or test non-sterile APIs and atypical APIs, other than release testing.
You must apply to add this type of foreign building to a DEL. For information, refer to Submitting an amendment to the API foreign building annex. You do not need to apply to renew this type of foreign building.
Figure 6 - Text description
The flowchart outlines the process for a foreign building listed on the alternate sample retention (ASR) annex of a DEL, whether it be located in an MRA country or a non-MRA country. The foreign building is responsible for retaining samples on behalf of the importer or distributor (depending on who is retaining the samples).
You must apply to add this type of foreign building as an ASR building to a DEL. For information, refer to Submitting an amendment to the ASR annex. You do not need to apply to renew this type of foreign building.
Figure 7 - Text description
The flowchart outlines the process for requesting Health Canada’s assessment of updated GMP evidence for a foreign building that was assigned a non-compliant rating listed on either the API FB Annex or the FB Annex for any licensable activity.
You must apply to have updated GMP evidence reassessed. For more information, refer to the section on Reassessing non-compliant ratings.
Figure 8 - Text description
The flowchart outlines the process for requesting a foreign onsite inspection of a foreign building that does not have updated GMP evidence whether it be located in an MRA country or a non-MRA country.
You must apply for a foreign onsite inspection request of a foreign building with a cover letter and FRM-0213. Health Canada will evaluate the information in the application and will decide if an inspection is necessary. For more information, consult Requesting a foreign onsite inspection.
Figure 9 - Text description
The flowchart outlines the process for submitting an application to report an administrative change (such as a change in the foreign building name, address, or activities, categories, or dosage forms) related to a foreign building on the API FB Annex or the FB Annex.
If changes occur, you must submit an application to notify Health Canada. Refer to Submitting an amendment for changes related to a foreign building on the DEL.