On May 26, 2021, Health Canada extended the timelines for activities related to Nitrosamines Risk Assessment in consideration of the on-going COVID-19 pandemic and challenges associated.
To mitigate the risk of presence of nitrosamine impurities, Health Canada has requested that Market Authorization Holders (MAHs) follow a three-step process for assessing and controlling the nitrosamine impurities in all human pharmaceutical products (prescription and non-prescription (over-the-counter)) containing chemically synthesized active pharmaceutical ingredients (APIs).
The initial deadline to complete the risk assessment (Step 1) was extended to March 31, 2021. On April 14, 2021, Health Canada issued a follow up letter requesting affected companies to indicate their status with respect to the completion of Step 1. Based on these findings, the extended timelines announced on May 26th are as follows:
- Annex 1: Risk Assessment Attestation Letter – extended to July 30, 2021 (previous due date was May 14, 2021)
- Annex 2: Summary of Completed Risk Assessments – extended to Sept. 1, 2021 (previous due date was June 1, 2021)
- Annex 3: Details Regarding Incomplete Risk Assessments (if applicable) – extended to July 30, 2021 (previous due date was May 14, 2021)
It should be noted that Market Authorization Holders (MAHs) are still advised to submit the annexes to Health Canada as soon as possible despite of this extended timelines.
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The experts at MCS associates can support your compliance requirements by working with you to review, create or support Nitrosamines Risk Assessment. If you require testing, Canadian Analytical Laboratories provides analysis for drug products, raw materials, and active pharmaceutical ingredients (APIs) to detect, identify and quantify the presence of nitrosamines using LC/MS/MS.