How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Potential GMP issues, reassessing NC ratings

On this page

• Foreign buildings with potential GMP issues
• Reassessing non-compliant ratings

This section describes:

• how Health Canada monitors and responds to potential health and safety issues involving a foreign building
• what you must do for us to reassess a non-compliant foreign building

Foreign buildings with potential GMP issues

Health Canada actively monitors for potential health and safety issues at foreign buildings that conduct licensable activities. We respond to these issues as soon as we become aware of them, from:

• our own inspections or reviews of good manufacturing practices (GMP) evidence
• adverse reaction reports
• notifications from companies
• notifications from regulatory or qualified authorities

We will initiate a review of the foreign building when we identify an issue with GMP compliance.

Visit the list of foreign buildings that we have reviewed or are reviewing:

• Inspection tracker: Drug manufacturing establishments

While we actively monitor for potential health and safety issues, importers are responsible for meeting the notification requirements.

Note: If you also hold a drug identification number (DIN), you must notify Health Canada if there is new safety information related to any serious risk of injury to human health involving regulatory issues in foreign countries. This is outlined in section C.01.050 of the Food and Drug Regulations (FDR).

Use this form to report:

• Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health

For more information on notification requirements and risk notifications, consult:

• Guidance on drug establishment licences (GUI-0002)
• Notifying Health Canada of foreign actions: Guidance document for industry

Health Canada assessment

Once we are aware of a health and safety issue involving a foreign building, we issue a request for information to importers who have the building on their licence or have asked to add the building to their licence. Any reviews of active drug establishment licence (DEL) applications associated with the foreign building may be delayed during this review period.

DEL holders who are affected may withdraw their active DEL applications and resubmit later.

Canadian importers who receive a request for information must respond in a timely manner so we can review the foreign building's compliance status. Examples of information that may be requested include:

• an inspection report from a regulatory or qualified authority
• GMP observations corresponding to the inspection
• corrective actions
• risk assessments for all products imported or intended for import into Canada that are fabricated, packaged/labelled or tested at the foreign building
  • must demonstrate the impact of the GMP observations on the quality of the products and identify risks or mitigation measures

Once we complete our review, we inform the Canadian importers of 1 of 2 outcomes:

1. Health Canada has no remaining critical GMP concerns for the foreign building:
   • importers may continue or start to import from the foreign building on their DEL
2. Health Canada has remaining GMP concerns for the foreign building:
   • the foreign building will not be added to your DEL, or we may ask you to stop importing from the foreign building and remove the foreign building from the licence

Note: Depending on the risks identified during the review, other compliance and enforcement actions may be taken, for example:

• adding or amending terms and conditions (T&Cs) to the Canadian importer's licence
• shortening the "new evidence required by" (NERBY) date
• increasing the frequency of inspections
• recalling or issuing a stop sale order on a product

Learn more:

• Compliance and enforcement policy for health products (POL-0001)
• Drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement policy (POL-0004)

Reassessing non-compliant ratings

Health Canada must reassess foreign buildings with non-compliant ratings before they can be added to DELs. If the foreign building is already compliant, follow the instructions in Submitting DEL amendment applications. Before you submit your application, check the compliance status of your foreign building in the Drug and health product inspections database.

To add a foreign building with a non-compliant rating, you must submit a:

• DEL amendment application with new GMP evidence
• request for us to reassess the GMP compliance rating
• FRM-0033

To request a reassessment of a non-compliant foreign building on your FB annex or API FB annex:

• complete the applicable sections of FRM-0033
• follow the instructions in Full GMP evidence to support compliance of a foreign building

The new GMP evidence must include:

• an inspection report issued by a regulatory or qualified authority that is more recent than the inspection that resulted in the non-compliant rating and
• a document that shows how each GMP observation from the non-compliant inspection has been resolved and verified in the new inspection

The following is not sufficient GMP evidence to support the reassessment of a non-compliant foreign building:

• an extra-jurisdictional certificate of compliance (EJ CoC)
  • submit the full GMP evidence (inspection report) corresponding to the EJ CoC so that we can review the observations and corrective actions taken to ensure the issues that led to the non-compliant rating have been adequately addressed
• corporate or consultant audit reports
  • audits are accepted based on the risk profile of a foreign building
  • after a non-compliant rating or a regulatory or qualified authority has identified potential GMP issues, the risk profile of the foreign building has changed
  • due to the change in risk profile of the foreign building, we rely on our own onsite inspection or accept an inspection report from a trusted regulatory or qualified authority to reassess the GMP issues and ensure they have been adequately addressed

Importers cannot import until Health Canada confirms the foreign building is compliant with the FDR and is listed on their DEL.

Also, if the foreign building is intended to be listed on the API FB annex, you must submit an amendment to the API FB annex application after we have confirmed that the foreign building is compliant. The application should include the information described on this page as well as the information outlined in Submitting an amendment to the API FB annex.