Guidance Documents

Guidance documents have been created to help the natural health product (NHP) industry familiarize itself with the regulatory requirements of the Natural Health Products Regulations.

Links to these documents can also be found in the sections to which they apply in the Applications and Submissions topic - Clinical Trials, International Trade Certificates, Product Licensing, or Site Licensing.

General Information

• Consultation on the new Prescription Drug List
  Date: December 24, 2012
• Reconsideration Process
  Date: October 2008
• Overview of the Natural Health Products Regulations
  Date: January 15, 2004

Adverse Reactions

• Procedure Document - The Release to the Public of Information Obtained from Adverse Reaction and Medical Device Incident Reports
  Date: August 11, 2011
• Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products
  Date: August 19, 2009
  
  Adverse Reaction Reporting for Health Care Providers and Consumers
  Date: January 2004

Advertising

• Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products)
  Date: October 2006

Clinical Trials

• Clinical Trials
  Date: October 30, 2005

Compliance

• Natural Health Products Compliance and Enforcement Policy (POL-0044)
  Date: August 2010
  • Annex to the Natural Health Products Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093)
    Date: August 2010
• Transition
  Date: November 2003

International Trade Certificates

• Notice-Revisions to the Guidance on the Application for International Trade Certificates for Natural Health Products
  Date: December 2009
• Application for International Trade Certificate for Natural Health Products
  Date: April 2010 - Version 1.0

Product Licensing

• Pathway for licensing natural health products used as traditional medicines
• Pathway for licensing natural health products making modern health claims
• Notice to Stakeholders on Nattokinase
  Date: November 2012
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
  Date: October 2010
  • Fact Sheet: Schedule A Claims for Natural Health Products
    Updated: November 2010
• Notice to Product Licence Applicants - Traditional Claim Submission:Evidence Criteria and Evidence Assessment Template
• Management of Product Licence Applications (PLA) for Natural Health Products
• Notice-Product Licence Applications for Natural Health Products Containing Probiotics
  Date: January 2010
• Notice - Labelling of Natural Health Products Containing Gluten
  Date: January 2010
• Notice - Guidelines for the Use of Synephrine in Natural Health Products
  Date: January 2010
• Notice-Update on the Assessment of Naturally-Sourced Medicinal Ingredients found on Schedule F
  Date: December 2009
• Guidance Document-Human-Use Antiseptic Drugs
  Date: December 2009
• Notice - To Product Licence Applicants - Evidence Criteria and Evidence Assessment Template 
  Date: November 2009
• Technical Report - To summarize the scientific rationale for the Natural Health Products Directorate's new guidance on the regulation of soy isoflavone products 
  Date: 30 October 2009
• Notice - Revised Guidelines for the Use of Stevia in Natural Health Products 
  Date: September 2009
• Notice-Gluten-free Claims for Natural Health Products
  This notice has been temporarily removed. For additional information regarding NHPs, please contact the Natural Health Products Directorate. We apologize for any inconvenience.
• Classification of Products at the Cosmetic and Drug Interface
  • Products at the Cosmetics-Drug interface
• Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats
  Date: June 2010, Version 2.0
• Product Licensing
  Date: December 2006
• Compendium of Monographs
  Date: November 2007 - Version 2.1
  • Lists of Monographs
  • Summary of NHP/DRUG Classification of TPD Category IV Labelling Standards Ingredients
    Date: February 1, 2006
• Evidence for Homeopathic Medicines
  Date: May 2007
  • HM Labelling Standard
    Date: November 2007
• Evidence for Quality of Finished Natural Health Products
  Date: June 2007
  • Finished Product Specifications Form - User Guide
  • Finished Product Specifications Form
  • Instructional Video on the Finished Product Specifications Form
    Date: October 2011
• Labelling
  Date: August 2006
  • Labelling Requirements Checklist
    Date: March 2010
• Master File Procedures
  Date: August 2006
• Post Licensing
  December 2007 - Version 1.0

Site Licensing

• Site Licensing
  Date: September 2007
• Good Manufacturing Practices
  Date: August 2006