Navigating Variation Requirements and Specific Requirements in Canada

1. Variation Requirements

Notice of Compliance (NOC) Changes - Quality Guidance:

The Post Notice of Compliance (NOC) Changes - Quality guideline can be found on Health Canada's homepage:

Post-Notice of Compliance (NOC) Changes – Quality Guidance - Canada.ca

(last update August 28, 2023)

Appendix 1: Quality Post-NOC Changes (human pharmaceuticals) = small molecules

(Appendix 2: Quality Post-NOC Changes (veterinary drugs)

Appendix 3: Quality Post-NOC Changes (biologics)

Appendix 4: Quality Post-NOC Changes (Schedule C drugs) = Radiopharmaceuticals, kits and generators

2. Specific requirements for specific changes

​Change in:	Requirement:	Last update
New manufacturing/quality control site	For any submission where Canada is involved, check with Novartis Canada several months prior to submission that the projected manufacturing/control sites are already "approved" in Canada (Drug establishment License database), and if so, also will not need any "renewal" of their status prior to dossier submission. GUI-0080 http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0080-eng.php	03-Nov-2021
(New) stability testing site	https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-document.html	19-08-2015
​DS/DP - Testing site	Method transfer protocol and report have to be provided	19-08-2015
DP line changes	Classified as regulatory relevant (covering worst case scenario )