Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document - Summary
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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 (i.e., changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations).
Who this guide is for
Sponsors of pharmaceuticals, biologics, and radiopharmaceutical drugs for human use
In this guide
- 1. Introduction
- 2. Guidance for implementation
- 3. Pre-Submission Enquiries
- 4. Documentation
- 4.1 Filing formats for submitting supporting data - Level I and Level II Changes
- 4.2 Supporting data common to Level I and Level II
- 4.3 Supporting data
- 4.4 Contextual information
- 4.5 Additional contextual information specific to Level I Changes
- 4.6 Additional contextual information specific to Level II (90 day) Changes
- 4.7 Supporting data - Level III Changes
- 5. Glossary
View complete guide
Download PDF (404 KB, 13 pages)
Details and history
Published: 2009/09/02
Updated: 2019/08/12
Part of topic(s): Guidance on legislation
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
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca
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