Post-Notice of Compliance (NOC) Changes – Quality Guidance 

From Health Canada

Overview

The Post-NOC Changes: Quality guidance assists sponsors with the classification of quality changes made to a new drug that has received a Notice of Compliance (NOC). It also provide sponsors with recommendations on the data to support a change which would be considered sufficient to allow a determination of the impact of the change on the quality of the new drug as it relates to safety, efficacy and/or effective use of the new drug.

Who this guide is for

  • Sponsor filing a submission with quality changes post authorization
  • Health Canada employees who are processing and screening submissions submitted for a quality change.

In this guide

View complete guide

Download PDF (1,426 KB, 269 pages)

Details and history

Published:
September 2, 2009
Updated:
September 15th, 2009; September 15th, 2011; October 15th, 2013; December 12th, 2014; February 2016; October 14, 2016
Consulted:
September 15, 2011
Part of topic(s):
Food and Drugs Act and Regulations

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email: hc.policy.bureau.enquiries.sc@canada.ca

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