Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products Being Exported

(January 7, 2008)

Unit name: Drug GMP Inspection Unit
Telephone: 613-957-1492
Fax: 613-957-6709
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3rd Floor
250 Lanark Avenue
Address Locator # 2003D
OTTAWA, Ontario
K1A 0K9

January 7, 2008

07-118666-624

To: All Interested Parties

I am pleased to inform you that a new version of the form entitled "Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products Being Exported", is now available for comments on the Health Canada's Compliance and Enforcement website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/form/index-eng.php

This document has been reviewed and amended providing a clearer understanding of requirements associated with the intention to invoke Section 37.

Yours very truly,

Original signed by

Diana Dowthwaite
Director General

Ce document est aussi disponible en français.


Section 37 of the Food and Drugs Act states as follows:

"This Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word «Export» or «Exportation» and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner."

The Export Certificate that must accompany the packaged food, drug, cosmetic or device can be found on the Health Canada website Establishment Licensing page at :

http://hc-sc.gc.ca/dhp-mps/compli-conform/licences/index-eng.php

You are asked to inform us of the packages and contents of products that are exported in compliance with Section 37 of the Food and Drug Act at the time of Drug Establishment Licence renewal. This form must be used when you intend to invoke Section 37 for any drug products fabricated in Canada that you are to export. Please complete the following and return this document to the Health Products and Food Branch Inspectorate at fax (613) 957-6709 or e-mail it to GMP_Questions_BPF@hc-sc.gc.ca.

Drug Establishment Licence Number:

Name of Establishment:

  • The above establishment does not intend to invoke Section 37 for any products that they are exporting.
  • As the above establishment intends to invoke Section 37 for exportation, I ensure that the Export Certificate has been duly signed by the Commissioner of Taking Oaths, that the Export Certificate is kept on the premises and covers the following products: (An attached list is acceptable.)

Please provide a copy of the duly signed Export Certificate for these packages.

  • Product Name
  • DIN (if any)
  • Dosage Form
  • Strength
  • Lot number
  • Expiry Date
  • Sterile (Y) or (N)

If you intend to market the same products for consumption in Canada, please provide a statement of confirmation that the manufacturing of the packages for consumption in Canada meets all Good Manufacturing Practices.

Be advised that evidence of Good Manufacturing Practices compliance is required to rescind Section 37.

Name of Regulatory Person:

Signature of Regulatory Person:

Date:

Report a problem or mistake on this page
Please select all that apply:

Privacy statement

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: