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

November 30, 2018
Our file number: 18-109026-937

Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance. The Post-Notice of Compliance (NOC) Changes - Quality Guidance released in September 2009 provided a guidance regarding the conditions for the categorization of any post authorization change and recommendations for supporting documentation.

In September 2011, revisions to Post-NOC Changes Quality: Appendix 1 eliminated the Level II (Notifiable Change) category and moved higher risk submissions to the Level I category while placing lower risk ones in the current Level III grouping.

In October 2013, modifications were made to the categorization, the conditions and application requirements for various quality changes.

In December 2014, change #2 was deleted and a modification was made to the conditions in change #23 in Appendix 1.

In February 2016, various changes were made to Appendices 1, 2, 3, 5 and 8 (for example, additions or modifications to the categorization, the conditions and supporting data required etc.).

In October 2016, the conditions and supporting data for changes 2a and 2b were made to Appendix 1 and a correction to the previously approved description for change 27b in Appendix 2 were made to the English (pdf and html) and French (html) versions.

This version of the guidance reflects the following changes:

  • Appendices 1, 2, 3, 4 - addition, deletion or modification to the description of some of the changes, the conditions to be fulfilled, the reporting categories and  supporting data required,
  • Appendix 7 – addition of an example and modification of existing examples, and
  • Appendix 8 – revision to an existing acronym and the addition of new acronyms,
  • Rewording of various sections to add clarity to existing text to provide consistency with notices or policies that have been issued since the last update,
  • Updating text to reflect Health Canada’s adoption of ICH guidelines or annexes (e.g., Q4B , Q8 and Q11),
  • Clarifying when Level III changes should be filed and what documentation should be submitted.

Changes in the Post-Notice of Compliance (NOC) Changes - Quality Guidance are effective on November 28th, 2018; all quality changes for market authorized drug 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 3102C5
Ottawa, Ontario
K1A 0K9

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

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