Health Canada - Nitrosamine impurities in medications (Update 28Jul21)

[Yosukemino]

Hi, @MonazBmysorewala. There is Q&A ver. 2020-20-15 in the following thread. I hope you find this helpful.

UPDATED - Health Canada - Q&A Document on Nitrosamine

Health Canada spell it out quite clear on its Q&A Document on Nitrosamine (Updated 15Dec20): Q6: What are the responsibilities of API manufacturers, excipient manufacturers, drug product manufacturers, MAHs, and importers? To enable this robust risk assessment, information should be made available by API, excipient, and drug product manufacturers to the MAH. Q8: Is it acceptable to rely solely on statements or declarations by manufacturers and suppliers in lieu of completing risk assessm…