What’s new
An updated version of Health Canada’s Guidance on nitrosamine impurities in medications has been posted online. Several updates have been incorporated into the Nitrosamines guidance document, including:
- Health Canada’s change in expectation for reporting on the detection of nitrosamine impurities, notably:
- Market Authorization Holders (MAHs) no longer need to inform Health Canada every time an elevated level of a nitrosamine impurity is detected. MAHs are only expected to notify Health Canada if a decision to initiate a recall is made and reporting should be conducted as specified in the Drug, natural health product and biocide recall guide (GUI- 0039) (number 15)
- General and Quality:
- Nitrosamine risk mitigation-related changes are no longer required to be filed as Level I (Supplement) submissions by default (number 13)
- These changes should be classified and filed in accordance with Health Canada’s Post-Notice of Compliance (NOC) Changes - Quality Guidance, using a risk-based approach that considers the nature, scope, and potential impact on product quality, safety, and efficacy to determine the appropriate reporting category (Level I or Level III) (number 13)
- Safety:
- Added new contact information for enquiries related to applicable acceptable intake (AI) limit(s), including new AI limit proposals (number 24)
- Appendix 2:
- The decision tree in Appendix 2 has been updated to reflect the revised expectations for MAHs filing Nitrosamine risk mitigation-related changes.