Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance Document

July 31, 2019
Our file number: 19-112899-963

Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes - Quality guidance document.

The Post-Notice of Compliance (NOC) Changes - Quality Guidance released in September 2009 provides a comprehensive guidance regarding the conditions for the categorization of any post authorization change and recommendations for supporting documentation.

The guidance has been revised to reflect the following changes:

Appendix 1

• Clarification of the conditions to be fulfilled and the reporting categories, for Supplements and Annual Notifications,
• Addition of changes that are considered Annual Notifications and changes to the supporting data for a Supplement and an Annual Notification,
• Change 16, Condition 1 modified to allow for changes in colour or flavour and addition of supporting information for the change.

Appendix 2

• Revisions made to the supporting data and clarification of one condition,
• Revisions to the French language version of the guidance document to better reflect the content of the English version of the guidance document.

For details, refer to the Document Change log in the guidance document.

Changes in thePost-Notice of Compliance (NOC) Changes - Quality Guidance are effective from the date of posting on the Health Canada website; all post-authorized Quality submissions should be reported as per the procedures detailed within.

Questions or concerns related to these guidance documents 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 3102C1
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca