Site Licence 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.

For Viewing Purposes Only - Licence applicants must use the available WORD or PDF versions of this form when submitting it to the Natural Health Products Directorate (NHPD).

Protected when completed

Health Products and Food Branch
Natural Health Products Directorate

Health Canada Use Only

  • Submission No:
  • File Number:
  • Date/Time of Receipt:

Part 1 - Applicant or Licensee Information

A. - Applicant or Licensee (This will be the site licence holder)

  • Applicant /Company Name:
  • Company code(If known):
  • Address, Street/Suite/P.O. Box:
  • City/Town:
  • Prov.:
  • Country: CANADA
  • Postal:

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

  • Name
    • Mr.
    • Ms.
    • Dr.
  • Surname:
  • Given Name:
  • Title:
  • Language preferred
    • English
    • French
  • Company Name (If different from Applicant/Licensee):
  • Address same as "A"
  • Street/Suite/P.O. Box:
  • City/Town:
  • Prov. :
  • Country: Canada
  • Postal:
  • Telephone No:
  • Ext:
  • Fax No:
  • E-mail:

C - Contact for this Application (This is the contact person for site licence application specific questions)

  • Contact same as "B"
  • Name
    • Mr.
    • Ms.
    • Dr.
  • Family Name:
  • Given Name:
  • Title:
  • Language preferred
    • English
    • French
  • Company Name (If different from Applicant/Licensee):
  • Address same as "A"
  • Street/Suite/P.O. Box:
  • City/Town:
  • Prov.:
  • Country: Canada
  • Postal:
  • Telephone No:
  • Ext:
  • Fax No:
  • E-mail:

D. - Quality Assurance Person (Person in charge of Applicant's Quality Assurance Activities)

  • Contact same as "C"
  • Name
    • Mr.
    • Ms.
    • Dr.
  • Surname*:
  • Given name*:
  • Title:
  • Preferred Language:
    • English
    • French
  • Company Name (* if different from Applicant/Licensee):
  • Address same as "C"
  • Street/Suite/PO Box*:
  • City - Town*:
  • Province*:
  • Country: Canada
  • Postal Code*:
  • Telephone No*:
  • Ext:
  • Fax No:
  • E-mail:

Part 2 - Submission Information

Site Licence Application

  • Indicate the type of application (select one only)
    • New Site Licence Application
    • Site Licence Amendment
    • Site Licence Renewal
    • Site Licence Notification Change
  • Site Licence Number (if applicable):

Part 3 - Canadian Site Information

Building Information

  • Building 1
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City / Town:
    • Province:
    • Postal Code:
    • Country: Canada
    • Name of Contact Person for this building:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form (QAR) of Equivalent
    • Supplementary QAR
    • Establishment Licence

  • Building 2
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City / Town:
    • Province:
    • Postal Code:
    • Country: Canada
    • Name of Contact Person for this building:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence

  • Building 3
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City / Town:
    • Province:
    • Postal Code:
    • Country: Canada
    • Name of Contact Person for this building:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence

  • Building 4
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City / Town:
    • Province:
    • Postal Code:
    • Country: Canada
    • Name of Contact Person for this building:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence

Part 4 - Foreign Site Information

  • Foreign Company Name:

  • Building 1
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City - Town:
    • Province - State:
    • Postal/Zip Code:
    • Country:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence
    • Foreign Company Name:

  • Building 2
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City - Town:
    • Province - State:
    • Postal/Zip Code:
    • Country:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence
    • Foreign Company Name:

  • Building 3
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City - Town:
    • Province - State:
    • Postal/Zip Code:
    • Country:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence
    • Foreign Company Name:

  • Building 4
    • Storage/Warehouse use only
      • Yes
      • No
    • Dwelling House
      • Yes
      • No
    • Building Name:
    • Activity Type

  • Manufacturing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Packaging
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Labelling
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete

  • Importing
    • Sterile Dosage NHP
      • Add
      • Delete
    • Homeopathic Medicines
      • Add
      • Delete
    • Non-sterile NHP
      • Add
      • Delete
    • Address, Street / Suite:
    • City - Town:
    • Province - State:
    • Postal/Zip Code:
    • Country:
    • Name of Quality Assurance Person for this building:
    • Attached Quality Assurance Report Form
    • Supplementary QAR
    • Establishment Licence

Part 5 - Attestation

- I attest that the building(s), practice(s), procedure(s) used for conducting activities in our facility comply with the good manufacturing practices set out in Part 3 of the Natural Health Products Regulations.

  • Name of Quality Assurance Person
  • Signature
  • Date
    yyyy mm dd
  • Name of Authorized Senior Official
  • Signature
  • Date
    yyyy mm dd

HC/SC 9270E (12-2003)

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