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Drugs and Health Products

Electronic Product 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.

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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

Footnotes

denotes mandatory

if yes, complete Animal Tissue Form