Clinical trials drug importation Frequently Asked Questions

• Drug Importation
  
  1. What documentation is required in order to ship an investigational drug into Canada?
  2. For a CTA, if the clinical trial sponsor is located outside Canada, and the drug is being sent directly to each clinical trial site, what are the documents required?
  3. For a CTA-A, where the clinical trial sponsor is located outside Canada, and the drug is being imported for the purposes of the trial, do section D and Appendix 1 have to be completed for each importer?
  4. If the Authorization for a Third Party to Import the New Drug (Appendix 1) is submitted after the initial CTA was submitted, is there a waiting period before the drug can be shipped to the site?

• Record Keeping
  1. My clinical trial began prior to September 1, 2001, before the requirement to maintain all records for a period of 25 years. How long are my records to be kept?

Drug Importation

1. What documentation is required in order to ship an investigational drug into Canada?

When a drug is imported into Canada to be used within the context of a clinical trial, please include / attach a copy of the No Objection Letter (NOL) for the applicable trial with the drug shipment.

2. For a CTA, if the clinical trial sponsor is located outside Canada, and the drug is being sent directly to each clinical trial site, what are the documents required?

If the drug is sent directly to each site, then each site is listed as an importer.

• Enter the name and address of one importing site in Section D of the Drug Submission Application Form (HC/SC 3011), and use an additional sheet of paper to list all other sites.
• The name can be that of the Qualified Investigator or the pharmacy receiving the drug at the clinical site.
• Appendix 1 is completed for each site listed as an importer in Section D of the Drug Submission Application Form (HC/SC 3011).

3. For a CTA-A, where the clinical trial sponsor is located outside Canada , and the drug is being imported for the purposes of the trial, do section D and Appendix 1 have to be completed for each importer?

Enter the name and address of one importing site in Section D, and use an additional sheet of paper to list all other sites.

If the importers have not changed when a CTA-A is filed, Appendix 1 does not need to be resubmitted.

4. If the Authorization for a Third Party to Import the New Drug (Appendix 1) is submitted after the initial CTA was submitted, is there a waiting period before the drug can be shipped to the site?

Once a No Objection Letter (NOL) for the trial in question has been obtained from Health Canada , include / attach a copy with the drug shipment to Canada.

Record Keeping

1. My clinical trial began prior to September 1, 2001, before the requirement to maintain all records for a period of 25 years. How long are my records to be kept?

Prior to September 1, 2001, the ICH Good Clinical Practice Guidelines (Section 4.9.5) were followed:

"4.9.5: Essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained (see 5.5.12)."