Foreign Site Reference Number Application Form

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

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.

Health Canada Use Only

  • 1. Submission Number
  • 2. File Number
  • 3. Date/Time of Receipt

A. Applicant

  • 4. Applicant/Company Name
  • 5. Company Code (If known)
  • 6. Address: Street/Suite/PO Box
  • 7. City - Town
  • 8. Province/State
  • 9. Country
  • 10. Postal Code/ Zip Code

B. Senior Official (This is the name of the principal contact person for the applicant/company)

  • 11. Name
    • Mr.
    • Ms.
    • Dr.
  • 12. Title
  • 13. Language preferred:
    • English
    • French
  • 14. Company Name (if different from Applicant/Licensee)
  • 15. Address same as "A"
  • 16. Street/Suite/PO Box
  • 17. City - Town
  • 18. Province/State
  • 19. Country
  • 20. Postal Code/Zip Code
  • 21. Telephone No.
    • Ext.
  • 22. Fax No.
  • 23. E-mail

C. Contact For This Application (This is the contact person for this application)

  • 24. Contact same as "B"
  • 25. Title
  • 26. Language preferred:
    • English
    • French
  • 27. Name
    • Mr.
    • Ms.
    • Dr.
  • Surname
  • Given Name
  • 28. Telephone No.
    • Ext.
  • 29. Fax No.
  • 30. E-mail

D. Submission Type

  • 31. Indicate the type of application (select one only)
    • New Application
    • GMP Evidence (Information Update)
    • GMP Evidence Renewal
  • REF#

E. Building Information

  • 32. Address
  • 34. City:
  • 35.Country
  • 36.Postal Code
  • 37. Activity Type:
    • Manufacturing
      • Add
      • Delete
      • Sterile Dosage
      • Homeopathic Medicines
    • Packaging
      • Add
      • Delete
      • Sterile Dosage
      • Homeopathic Medicines
    • Labelling
      • Add
      • Delete
      • Sterile Dosage
      • Homeopathic Medicines
  • 38. Evidence Type:
    • Quality Assurance Report
    • Supplementary Quality Assurance Report (HM)
    • 3rd Party Audit Report
    • Other (TGA, FDA, etc.)
  • 39. Quality Assurance Person:
    • Name
    • Telephone Number

F. Attestation

"I attest that the building(s) , practice(s), procedure(s) used for conducting activities in all facilities listed on this application comply with the good manufacturing practice requirements outlined in Part 3 of the Natural Health Products Regulations.

  • 40. Name of Authorized Senior Official
  • 41. Signature
  • Date yyyy/mm/dd
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