Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
Useful Resources
- Find information regarding submission requirements at Guidance Document: Management of Drug Submissions and Applications
- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy
- Post-Notice of Compliance (NOC) Changes: Quality
Related acts and regulations
Date adopted: 2009/09/02
Date posted: 2020/03/23
Effective Date: 2020/04/01
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
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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