Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Framework Guidance Document
June 26, 2018
Our file number: 18-103275-253
Health Canada is pleased to announce the release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Framework.
This guidance document provides a framework for sponsors intending to make changes to new drugs that have received a Notice of Compliance pursuant to section C.08.004 of the Food and Drug Regulations by providing: a brief description of the reporting categories and general submission requirements.
This update of the guidance reflects the following changes:
- Clarification of when Level III changes should be filed and the documentation that should be submitted.
- Consequential changes have also been made to include new initiatives that have been implemented over the past several years:
- The interim measure on how Health Canada initiated safety changes for human drugs under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) (2014) are managed.
- The Plain Language Labelling (PLL) requirements for Level I changes to include Mock-Up labels for prescription drugs and those administered or obtained through a health professional which came into force on June 13, 2015 and on June 13, 2017 for all non-prescription drugs.
This guidance document becomes effective from the date of posting on the Health Canada website. Questions or concerns related to this guidance document should be directed to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
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