Guidance Documents – Legislation and guidelines – Natural health products

Guidance documents have been created to help the natural health product 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.

COVID-19

Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic

Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer

Interim guide on the production of ethanol for use in alcohol-based hand sanitizers

Production of isopropyl alcohol for use in alcohol-based hand sanitizers: interim guide

Guide on Health Canada's Interim Expedited Licensing Approach for the Production and Distribution of Alcohol-Based Hand Sanitizers

General Information

• Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order
  Date: August 28, 2024
• Switching a medicinal ingredient from prescription to non-prescription status (2024)
  Date: August 14, 2024
• What's new: Natural and non-prescription health products
  Date: July 6, 2022
• Guidance Document on the Distribution of Drugs as Samples
  Date : April 29, 2020
• Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
  Date : June 28, 2019
• Notice to Stakeholders Regarding Site Licensing Update
  Date: December 1, 2015
• Consultation on the new Prescription Drug List
  Date: December 24, 2012
• Reconsideration Process
  Date: October 2008

Adverse Reactions

• 
  Guidance on releasing information from adverse reaction and medical device incident reports to the public
• Date: August 31, 2022
• 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

Clinical Trials

• Clinical Trials
  Date: October 30, 2005

Compliance

• Natural Health Products Compliance and Enforcement Policy (POL-0044)
  Date: August 2010
• Transition
  Date: November 2003

International Trade Certificates

• Guidance for Industry on Third-Party Issuance of International Trade Certificates
  Date: September 3, 2013

Product Licensing

• Management of Product Licence Applications for Natural Health Products
  Date: July 2022
• Data requirements for switching medicinal ingredients from prescription to non-prescription status
  Date: July 2022
• Pathway for licensing natural health products used as traditional medicines
  Date: July 2022
• Pathway for licensing natural health products making modern health claims
  Date: July 2022
• 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
• 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: July 2017
• Product Licensing
  Date: December 2006
• Compendium of Monographs
  Date: November 2007 - Version 2.1
  • Lists of Monographs
• Evidence for Homeopathic Medicines Date: July 2022
• Quality of Natural Health Products Guide
  Date: May 2013
  • Finished Product Specifications Form - User Guide
  • Finished Product Specifications Form
  • Instructional Video on the Finished Product Specifications Form
    Date: October 2011
• Labelling
  Date: July 2022
  • Labelling Requirements Checklist
    Date: July 2022
• Master File Procedures
  Date: August 2006
• Post Licensing
  December 2007 - Version 1.0

Site Licensing

• Site Licensing
  Date: December 2015
• Good Manufacturing Practices
  Date: December 2015