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Drugs and Health Products

Foreign Site Reference Number Application Form

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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