Product Licensing Guidance Document

Version 2.0 - December 2006

Cat. H164-36/2006E
ISBN 0-662-44268-7

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Summary of key changes to the Compendium of Monographs for natural health products

Natural Health Products Directorate Guidance Document

Également offert en français sous le titre :
Document de référence concernant la licence de mise en marché

^© Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2006.

Contact the Natural Health Products Directorate

Natural Health Products Directorate
Health Canada
2936 Baseline Rd., Tower A
Ottawa, Ontario
K1A 0K9

Telephone: 1-888-774-5555
Fax: (613) 948-6810
Email: NHPD_DPSN@hc-sc.gc.ca

Overview

All natural health products (NHPs) marketed for sale in Canada are subject to the Food and Drugs Act. The regulatory requirements specific to NHPs are outlined in the Natural Health Products Regulations (the Regulations).

This guidance document is intended to help product licence applicants interpret the terminology used in Section 5 of the Regulations and to complete a product licence application form and animal tissue form (if applicable).

Included in this guidance document are a description of the different submission types and their specific requirements. The product licence application form and all other relevant forms may be found on the Internet.

The product licence application form (along with the label text and supporting safety, efficacy and quality information, when required) may be used to apply for a new product number (NPN or DIN-HM in the case of homeopathic medicines) from the Natural Health Products Directorate (NHPD) as part of the product licence or it may also be used to apply for an amendment or provide a notification of changes for products that are already licensed.

Sections of the Regulations text appear in boxes in relevant locations throughout this guidance document. A complete version of the Regulations is available.

The information in this guidance document is based on the Natural Health Products Regulations, which were published in Canada Gazette, Part II, on June 18, 2003. The Regulations came into force on January 1, 2004.

Table of Contents

• Overview
  
  
• 1.0 Applications for Product Licences
  
  
• 2.0 Types of Product Licence Applications and Requirements
  • 2.1 Compendial Applications
  • 2.2 Traditional Claim Applications
  • 2.3 Non-Traditional Claim Applications
  • 2.4 Homeopathic Applications
  • 2.5 TPD Category IV/Labelling Standard Applications
    • 2.5.1 TPD Category IV Monographs and Labelling Standards for Vitamin and Mineral Applications
  • 2.6 Homeopathic DIN Applications
  • 2.7 Transitional DIN Product Applications
    
    
• 3.0 How to Submit an Application
  • 3.1 Document Presentation Recommendations
  • 3.2 How to Submit a General Submission Inquiry
    
    
• 4.0 Product Licence Application Form
  • 4.1 Referencing Submissions
  • 4.2 Site Requirements for Product Licence Application
  • 4.3 Medicinal Ingredient Product Licence Application Requirements
    • 4.3.1 Proper name
    • 4.3.2 Common Name
    • 4.3.3 Quantity
    • 4.3.4 Synthetic
    • 4.3.5 Potency
    • 4.3.6 Source Information
    • 4.3.7 Extract
  • 4.4 Non-Medicinal Ingredient Product Licence Application Requirements
  • 4.5 Recommended Conditions of Use
    
    
• 5.0 Animal Tissue Form
  • 5.1 Instructions for Completing the Animal Tissue Form
    
    
• Appendix 1: Example of a Compendial Application
  
  
• Appendix 2: Example of a Traditional Application
  
  
• Appendix 3: Example of a Non-Traditional Application
  
  
• Appendix 4: Example of a TPD Category IV/Labelling Standard Application
  
  
• Appendix 5: Example of Transitional DIN Product Licence Application
  
  
• Appendix 6: Example of a Completed Animal Tissue Form
  
  
• Appendix 7: Non-Medicinal Ingredient List of Purposes
  
  
• Appendix 8: List of Acceptable Dosage Forms
  
  
• Appendix 9: List of Acceptable Routes of Administration