November 3, 2016
Our file number: 16-111620-530
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 comprehensive 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.
Changes in the Post-Notice of Compliance (NOC) Changes - Quality Guidance are effective immediately; all post authorized Quality submissions should be reported as per the procedures detailed within.
The effective date (September 30, 2009) remains for all other Post-NOC Changes guidance documents. Revisions to the Post-Notice of Compliance (NOC) Changes - Safety and Efficacy Guidance will be made when necessary.
Questions or concerns related to these guidance documents 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