Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

From: Health Canada

Date adopted: 2009/09/02
Date posted: 2020/03/23
Effective Date: 2020/04/01

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Overview

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.

Who this guide is for

Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use

View complete guide

For assistance

Contact us:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Fax: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca

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