The deadline for the first step of Health Canada’s risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products was March 31, 2021. This deadline applied to Market Authorization Holders (MAHs) of prescription and non-prescription drug products containing chemically synthesized APIs, and pertained to risk assessments to be completed by MAHs.
On April 14, 2021, Health Canada issued a letter to all MAHs to confirm the status of risk assessments and verify completion for all marketed, approved and dormant DIN products. A response is required by all MAHs by May 14, 2021 in the form of a ‘Risk Assessment Attestation Letter’. Subsequently, a ‘Summary of Completed Risk Assessments’ is due to be submitted to Health Canada by Jun. 01, 2021.
If your company has initiated, but not yet completed the risk assessments, Health Canada has asked for details on the actions completed to date, actions pending, details on the challenges you are facing in completing the risk assessments, and timelines on anticipated completion of risk assessments for all marketed, approved and dormant DIN products.
Should you, as a MAH, fail to respond to this request from Health Canada, or have not completed the risk assessments per the specified timelines, enforcement action may be taken following a referral to Health Canada’s Regulatory Operations and Enforcement Branch.
If you have any questions, please feel free to contact us.