Electronic Product Licence Application form

Natural Health Products Directorate

Primary Brand Name :
1. Tracking Number:

Part 1 - Applicant and Contact Information

A - Applicant or Licensee

• 4 Applicant/Company Name
• 5 Company Code
• 6 Street/Suite/Land Location
• 7 City - Town
• 8 Province - State
• 9 Country
• 10 Postal/ZIP Code

B - Senior Official

• 11 Name
  • Salutation
  • Surname
  • Given Name
• 12 Title
• 13 Language preferred
• 14 Company Name
• 15 Address same as Applicant/Licensee
• 16 Street/Suite/Land Location
• 17 City - Town
• 18 Country
• 19 Province - State
• 20 Postal/ZIP Code
• 21 Telephone No.
  • Ext.
• 22 Fax No.
• 23 E-mail

C - Contact for this Application

• 24 Contact same as Senior Official
• 25 Name
  • Salutation
  • Surname
  • Given Name
• 26 Title
• 27 Language preferred
• 28 Company Name
• 29 Address same as Applicant/Licensee
• 30 Street / Suite / Land Location
• 31 City - Town
• 32 Country
• 33 Province - State
• 34 Postal/ZIP Code
• 35 Telephone No.
  • Ext.
• 36 Fax No.
• 37 E-mail

D - Representative in Canada

• 38 Representative in Canada same as Contact
• 39 Name
  • Salutation
  • Surname
  • Given Name
• 40 Title
• 41 Language preferred
• 42 Company Name
• 44 Street/Suite/PO Box
• 45 City - Town
• 46 Country
• 47 Province - State
• 48 Postal/ZIP Code
• 49 Telephone No.
  • Ext.
• 50 Fax No.
• 51 E-mail

E - Contact to whom the Product Licence is to be Sent

• 52 Contact to Whom Product Licence is to be Sent
• Name if Not Applicable

Part 2 - Submission Type

A - Product Licence Application

• 53 Type of Application
• 54 Hypothetical Formulation

E - Submission Content

• 59a Designated Party Authorization
  • 59a-1  Count of Mail-in Designated Party Authorization Submissions
• 59b Label Text
  • 59b-1  Count of Mail-in Label Text Submissions
  • 59b-2  Count of Generated Label Text Attachments
  • 59b-3  Count of Label Text Attachments
• 59d Evidence Summary Report
  • 59d-1  Count of Mail-in Evidence Summary Report Submissions
  • 59d-2  Count of Evidence Summary Report Attachments
• 59e References
  • 59e-1  Count of Mail-in References Submissions
  • 59e-2  Count of References Attachments
• 59f  Safety Summary Report
  • 59f-1   Count of Mail-in Safety Summary Report Submissions
  • 59f-2   Count of Safety Summary Report Attachments
• 59g Quality Summary Report
  • 59g-1  Count of Mail-in Quality Summary Report Submissions
  • 59g-2  Count of Quality Summary Report Attachments
• 59h Other Claim Evidence
  • 59h-1  Count of Mail-in Other Claim Evidence Submissions
  • 59h-2  Count of Other Claim Evidence Attachments

F - Reference Submissions

• 60 Other Supporting Submission
  • 60a Company Number
  • 60b File Number
  • 60c Submission Number
  • 60d NPN/DIN-HM Number
  • 60e Contains Information to Support
    • Safety
    • Efficacy
    • Quality

G - NHPD Master File Reference

• 61 Supporting Master File
  • 61a Master File Number
  • 61b Contains Information to Support
  • 61c Safety Only
  • 61d Efficacy Only
  • 61e Quality Only
  • 61f  Complete Submission
  • 61g Letter of Access Enclosed

Part 3 - Site Information

• 62 Company Name
• 64 Number, Street - Suite - PO Box
• 65 City
• 66 Country
• 67 Province - State
• 68 Postal Code - Zip Code

Part 4 - Product Information

• 70 Primary Brand Name
• 71 Other Brand Names
  • 105 Route of Administration
  • 103 Dosage Form
  • 104 Sterile

A - Medicinal Ingredient(s)

• Medicinal Ingredient Number
• 73 Standard or Grade
  • Ingredient Type
• 77a Quantity
  • Additional Quantity
• 77b Unit
  • Additional Unit
• Ingredient Names
  • Approved Name
• 75 Proper Name
• 76 Common Name
• Source
• Source Material
• Synthetic
• Animal Tissue Used

B - Non-Medicinal Ingredient

• Non-Medicinal Ingredient Number
• 98 Standard or Grade
  • Approved Name
• 94 Common Name
• 95 Purpose
• 99a. Quantity
• 99b. Unit
• 100 Source Information
• 79 Animal Tissue Used

C - Ingredient(s) Used in Processing

• 101 Animal Tissue Used In Processing

D - Recommended Conditions of Use

• 102 Recommended Use and Purpose

Recommended Dose

• 107 Sub-Population Group
• Frequency
  • Min
  • Max
• Dosage
  • Min
  • Max
  • Dosage Units
• Additional Dosage Information
• 112 Directions of Use

Duration of Use

• Duration
  • min
  • max
  • neither
• 106c Duration Statement

Risk Information

• 113 Cautions and Warnings
• 114 Contraindications
• 115 Known Adverse Reactions

Part 5 - Label Text

Attestation