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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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

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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

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