The July 11, 2025, letter sets out new expectations for MAH’s regarding submission and implementation of necessary changes to their market authorizations effective August 1, 2025.
Health Canada’s Guidance on Nitrosamine Impurities in Medications provides the Department’s current thinking and recommendations on issues related to N-nitrosamine impurities. This guidance document will soon be updated to reflect the expectations described in the July 11, 2025, letter relating to the Step 3 timeline.
