How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Importer responsibilities
On this page
- Maintaining GMP evidence onsite
- Reporting changes related to a foreign building
- Compliance with terms and conditions
- Retaining samples of imported drug product
Canadian drug establishment licence (DEL) holders have defined responsibilities under the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR) to ensure the safety, efficacy and quality of drugs imported or sold in Canada.
Importers who fail to comply with these responsibilities, which are outlined in this section, may be subject to compliance and enforcement action.
Learn more:
Maintaining GMP evidence onsite
Importers must keep a copy of the good manufacturing practices (GMP) evidence used to support the GMP compliance of all foreign buildings listed on all of the annexes of their DEL at their Canadian site. This requirement is outlined in sections C.02.012, C.02.20, C.02.21 and C.02.24 of the FDR.
Maintaining and reviewing evidence onsite ensures that both the importer and Health Canada have oversight over the compliance of foreign buildings that supply product to Canada. It also ensures that the submitted GMP evidence covers the requested activities, drug categories and dosage forms in the DEL amendment application.
The evidence maintained and reviewed onsite should correspond to the type of evidence that is:
- submitted or attested to in your most recent DEL application for the building or
- indicated on your Table A: Foreign building conducting active pharmaceutical ingredient related licensable activities
For example, if an extra-jurisdictional certificate of compliance (EJ CoC) was the supporting evidence in your recent application for the foreign building, this evidence should be maintained onsite.
Importers can keep a copy of the redacted inspection report in cases where the report has confidential information. For example, the inspection report can include light redactions to hide customer names, employee names or product information. Redactions should be focused on confidential business information or a trade secret. Redactions of entire paragraphs are not acceptable.
The inspection report must be kept at the Canadian site for 1 year past the expiry date of the imported product, unless the licence indicates otherwise.
For more information on records, consult:
During a domestic inspection of an importer, a Health Canada inspector may verify that GMP evidence for foreign buildings on the licence is kept onsite. If you are not able to provide an original or redacted copy of the GMP evidence upon request by the inspector onsite, the foreign building can submit the evidence directly to us after being requested to do so by an inspector.
The importer and foreign building should have a quality agreement in place (either with the subcontracted foreign building or the direct supplier). The agreement should include provisions that the applicable inspection reports be submitted to us by the foreign building within 2 business days of receiving the request. We will provide instructions on how to submit at the time of the request.
Importers should always keep a copy of the cover letter, closing letter or GMP certificate that corresponds to the inspection report. They should do so even if a quality agreement is in place that includes a provision to supply evidence directly to Health Canada upon request.
For information on the content of a quality agreement, consult Section C.02.012, under "Agreement" in:
You should keep additional evidence onsite in scenarios where there are potential GMP issues for a foreign building on your licence. An example of this would be if the foreign building was the subject of a risk assessment by Health Canada for potential GMP issues.
For more information, refer to Foreign buildings with potential GMP issues.
Reporting changes related to a foreign building
Importers must inform Health Canada of any changes to the:
- foreign building's name (foreign establishment name) or address
- licensable activities, categories or dosage forms being conducted by a foreign building listed on your licence related to your imported products
This is set out in section C.01A.006 of the FDR. You must submit a DEL amendment application if any of the changes indicated in this section occur.
For more information, refer to Submitting an amendment for changes related to a foreign building on the DEL.
Compliance with terms and conditions
Health Canada may decide that we need to apply additional oversight to prevent risk to a person's health and safety. If we do so, we will add terms and conditions (T&Cs) to the licence or amend the T&Cs of the licence. This is set out in sections C.01A.008(4) and C.01A.012 of the FDR.
The importer must comply with all T&Cs listed on the DEL.
If you believe the T&Cs are no longer needed or should be amended, you must submit an application to us for the foreign building.
For information on submitting your application, consult:
Clearly indicate in the cover letter that you wish to have the T&Cs removed or updated and why. Your application will also require supporting GMP evidence that demonstrates the activities no longer require additional oversight and that the T&Cs can be removed or amended.
Upon GMP assessment, we may decide to maintain the same T&Cs if the updated evidence does not support their removal or amendment.
Retaining samples of imported drug product
Importers and distributors of drugs in dosage form must keep a sample of each lot or batch of a packaged/labelled drug in Canada for 1 year after the product has expired, unless otherwise specified on the licence. In some cases, we may permit a foreign building to be an alternate sample retention (ASR) building if specific requirements are met.
For more information, refer to Submitting an amendment to the ASR annex.
This requirement ensures that samples of finished drug products can be accessed if:
- Health Canada has a concern about their quality
- the importer or Health Canada needs to analyze a sample of the finished drug product
For details on the requirements of retention samples, consult section C.02.025, "Samples," in: