Health Canada updates guidance(incorrect post)

Drug Establishment Licensing Bulletin 161, January 12, 2024

Health Canada has updated the Guidance on nitrosamine impurities in medications

Updates include a new timeline for completing changes to the market authorization (step 3 of the call for review) for:

  • biological and radiopharmaceutical drug products
  • drug products containing chemically synthesized and semi-synthetic active pharmaceutical ingredients

This new date is August 1, 2025.

Updates have also been made to general, safety (Appendix 2) and quality-related topics (including Appendix 1). Examples of changes include:

  • additional recommendations for managing and submitting step 3 changes to the market authorization on risk mitigation measures (section 13)
  • updates to the thresholds for reporting to Health Canada on the presence of nitrosamine impurities in drug products (numbers 3 and 15)
  • established acceptable intakes (AI) for 3 additional nitrosamine impurities
  • revisions to the AI limits for 2 nitrosamine impurities

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

I could not find the updated guidance. Will it be available soon?


It appears that it refers to the October revision. Description fits the changes made in October.

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Thank you for pointing it out, @mflorea . Yes , you are right. I apologize for my mistake.