Health Canada updates guidance on nitrosamine impurities in medications

Drug Establishment Licensing Bulletin 176, April 30, 2024

Health Canada has updated the Guidance on nitrosamine impurities in medications.

Updates to general and quality-related topics include the following:

• when the submission of confirmatory testing results are not required
  • for example, for nitrosamine impurities in Appendix 1 that are classified as non-mutagenic
• managing and submitting Step 3 changes to the market authorization related to risk mitigation measures
  • includes changes that can be implemented as Level 3, annual notifications
• acceptable limits of quantitation for analytical procedures

The established acceptable intake (AI) limits for an N-nitrosamine impurity are in a separate tabbed page. This will make it easier to update the listing of established AI limits. The AI limits are set out in a table, which users can filter by date to identify recent additions. The table can also be downloaded in an excel format.

Sections that have updated from the previous version are identified with the descriptor "updated".

If you have any questions or comments, email us at bpsenquiries@hc-sc.gc.ca.