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.

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

Adverse Reaction Reporting
Date: January 15, 2004

Adverse Reaction Reporting for Health Care Providers and Consumers
Date: January 2004

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

Clinical Trials
Date: October 30, 2005

Transition
Date: November 2003

Compliance Guide for Natural Health Products
Date: November 2006

Application for International Trade Certificate for Natural Health Products
Date: July 14, 2006

Product Licensing
Date: December 2006

Compendium of Monographs
Date: October 2006

• Lists of Monographs
• Summary of NHP/DRUG Classification of TPD Category IV Labelling Standards Ingredients
  Date: February 1, 2006

Evidence for Homeopathic Medicines
Date: November 2006

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

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

• List of Acceptable Non-medicinal Ingredients
Date: February 16, 2004

Labelling
Date: August 2006

Master File Procedures
Date: August 2006

Site Licensing
Date: August 2006

Good Manufacturing Practices
Date: August 2006