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

Reconsideration Process
Date: October 2008

Overview of the Natural Health Products Regulations
Date: January 15, 2004

Adverse Reactions

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

Transition
Date: November 2003

Compliance Guide for Natural Health Products
Date: November 2006

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: November 2007 - Version 2.0

Product Licensing

Notice-Product Licence Applications for Natural Health Products Containing Probiotics 
Date: January 2010

Notice - Labelling of Natutal 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: March 2009

• Notice to Stakeholders
  Date: March 2009

Product Licensing
Date: December 2006

• Important Notice - Licensing of NHPs with DINs
  Date: November 2007

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
• New Assessment Stream for Homeopathic Medicines with Non-Specific Recommended Uses or Purposes
  Date: April 2008

Evidence for Quality of Finished Natural Health Products
Date: June 2007

Evidence for Safety and Efficacy of Finished Natural Health Products
Date: December 2006

Draft Guidance Document -- Schedule A and Section 3 to the Food and Drug Acts
Date: July 2008

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