The Health Product Compliance Directorate is advising you of a change in reporting expectations to Health Canada when nitrosamine impurities are detected in drug products marketed in Canada.
- During CAPA implementation and effective immediately, Health Canada will no longer be issuing No Objection Letters for the release of drug products with elevated nitrosamine levels.
- Effective immediately, MAHs no longer need to inform Health Canada every time an elevated level of a nitrosamine impurity is detected.
Health Canada’s Guidance on Nitrosamine Impurities in Medications will be updated to reflect the latest reporting expectation.
The details of the reporting changes can be found below.
Letter to Stakeholders – Information to Market Authorization Holders of Human Pharmaceutical Products Regarding Nitrosamine Impurities – EN/FR
