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

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

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:

Contact us by phone:
Toll Free:  1-866-339-4998
Telephone:  613-957-4284

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

Service standards: We answer e-mail and telephone messages within 1 business day.

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

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