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


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

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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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