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:

1. Clarification of when Level III changes should be filed and the documentation that should be submitted.
2. 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
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca