Health Canada has extended this step for one year. The filing of drug submissions to
make changes to market authorizations are now due by October 1st, 2023
The deadline for Step 1 (risk assessments) has passed. The deadline for Step 2
(confirmatory testing) has not been changed and remains as October 1st, 2022. Case-
by-case extensions for Step 2 can be considered under exceptional circumstances.
Please find attached a copy of the communication sent to all Market Authorization and
Drug Establishment Licence holders. Health Canada’s Guidance on nitrosamine
impurities in medications will also be updated to reflect this revised timeline.
