Site Licensing Forms

All businesses in Canada who wish to manufacture, package, label, or import natural health products for sale must hold a current site licence.

A site licence gives the licensee the authorization to manufacture, package, label or import natural health products in Canada. These activities must be carried out according to the good manufacturing practices outlined in Part 3 of the Natural Health Product Regulations.

Please use the PDF or Microsoft Word versions to fill the forms out - the HTML format should only be used for viewing the forms. The Natural Health Products Directorate no longer accepts hand-written applications.

Forms

• Instructions for Completing the Summary of Net Changes Form
• Application for Alternate Sample Retention
• Designated Party Authorization Form
• Notification Description Form
• Quality Assurance Report Form
  • (Note: please read the instructions for completing the form first)
• Site Licence Application Form
  • Guide for Completing the Site Licence Application Form
• Supplementary Quality Assurance Report Form
  • (Note: please read the instructions for completing the form first)
• Foreign Site Reference Number Authorization form
• Foreign Site Reference Number Application form

The Natural Health Product Directorate strongly encourages applicants to submit applications and replies to deficiency/information requests by courrier service (when the response is too large to fax) because of its greater reliability. Please note that we do not accept the submission of applications by fax.

Please send your submissions by courrier service to the Submission Management Division:

Natural Health Products Directorate
Submission Management Division
Qualicum Tower A
2936 Baseline Rd.
Ottawa, Ontario
K2H 1B3

Questions regarding submissions should be emailed to: nhpd_dpsn@hc-sc.gc.ca