Timelines for completing risk assessments for nitrosamine impurities extended 

Drug Establishment Licensing Bulletin 91, August 10, 2020

Health Canada issued a letter on October 2, 2019, to market authorization holders (MAHs). The letter indicated that MAHs are to follow a 3-step process for conducting nitrosamine impurity risk assessments of their drug products containing chemically synthesized APIs.

On August 10, 2020, we issued another letter outlining revised timelines to complete those risk assessments.

The COVID-19 pandemic continues to have an impact on MAHs. For this reason, we are extending the timeline for conducting step 1 of the risk assessment process to March 31, 2021. The October 1, 2022, timeline for completing steps 2 and 3 has not changed.

If you have any questions, you may email us at bpsenquiries@hc-sc.gc.ca.