Guidance Document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions

Overview

When Health Canada issues certain negative decisions related to the submission review process for a human drug, including hard-surface disinfectants, or a natural health product, the applicant may request a reconsideration of the decision. This document provides Guidance regarding the process.  This document replaces the guidance, “Reconsideration of Decisions Issued for Human Drug Submissions,” issued 2015/04/01.

Who this guide is for

Applicants and Sponsors with submissions to Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, Natural and Non-prescription Health Products Directorate, as well as regulatory staff from these directorates.

In this guide

• 1.0 Overview
• 2.0 Decisions Eligible for Reconsideration
  • 2.1 Issues Not Eligible for Reconsideration
• 3.0 Possible Outcomes of a Request for Reconsideration
  • 3.1 Decision Upheld
  • 3.2 Decision Partially Amended
  • 3.3 Decision Amended
• 4.0 The Reconsideration Process
  • 4.1 Overview
  • 4.2 Detailed Outline of Reconsideration Process
    • 4.2.1 Letter of Intent
    • 4.2.2 Request for Reconsideration
    • 4.2.3 Decision Regarding Process Path
    • 4.2.4 Internal Review
      • 4.2.4.1 Natural Health Product Class I Applications
    • 4.2.5 External Reconsideration Panel
      • 4.2.5.1 Selecting Members for a Panel
      • 4.2.5.2 Eligibility of External Panellists
      • 4.2.5.3 Selection of External Panellists
      • 4.2.5.4 Questions for the External Reconsideration Panel
    • 4.2.6 The Reconsideration Meeting
    • 4.2.7 Making Recommendations to the Director General
    • 4.2.8 Decision by the Director General
    • 4.2.9 Follow-up Action
• 5.0 Roles and Responsibilities
• 6.0 Information Formats and Address
• 6.1 Human Drugs
• 6.2 Natural Health Products

• Appendix A: Reconsideration Process Map
• Appendix B: Performance Targets
• Appendix C: Request for Human Drugs Reconsideration Template
• Appendix D: Request for Natural Health Products Reconsideration Template

View complete guide

Details and history

Published: November 30, 2015
Updated: April 1, 2019
Consulted: June 27, 2018

For assistance

Contact the Food and Drugs Act Liaison Office (FDALO) if you need assistance:

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Toll Free: 1-866-339-4998
Telephone: 613-957-4284

Contact us by email:
fdalo@hc-sc.gc.ca

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For more information about the Food and Drugs Act Liaison Office (FDALO) and services, please visit our webpage at http://www.healthcanada.gc.ca/fdalo