Site Licence Application Form

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)