Export Certificate for Drugs Exported Under Section 37 of the Food and Drugs Act

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Exporters exporting drugs in compliance with section 37 of the Food and Drugs Act are required to issue an export certificate in accordance with section A.01.045 of the Food and Drug Regulations. More information regarding section 37 of the Food and Drugs Act is available in Health Canada’s Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060).

Companies intending to invoke section 37(1) should notify Health Canada of such intention using this form.

Filling the Form

When filling the form, you are required to include the following information as part of the description of the article.

  • Product Name/Brand Name
  • Route of administration
  • Medicinal ingredient(s)
  • Canadian DIN (if applicable) or authorization number issued by the destination country
  • Dosage Form
  • Strength
  • Lot number

How to submit your Export Certificate to Health Canada

A copy of the export certificate can be sent to Health Canada’s Drug Establishment Licensing Unit (DELU), Health Product Compliance Directorate (HPCD), Regulatory Operations and Enforcement Branch (ROEB), Health Canada at the following coordinates:

By email at: hc.el.applications-le.sc@canada.ca

Or by Mail at:

Drug Establishment Licensing Unit (DELU)
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney’s Pasture
Address Locator # 1913D, Ottawa Ontario K1A 0K9

Contacts:

For more information on how to fill and submit the form to Health Canada please contact the Drug Establishment Licensing Unit at: hc.del.questions-leppp.sc@canada.ca

For other information regarding section 37 of the Food and Drugs Act you can contact Health Canada’s border compliance program at hc.hpbcp-pcpsf.sc@canada.ca

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