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

[Naiffer_Host]

Recent updates from Health Canada on their guidance document.

Content Update on 29-Jul-2021 :
This document was revised to update the an additional test method for metformin products has been developed by Health Canada.

Content Update on 26-May-2021 :
This document was revised to update the Overview: What we’re doing section.

Content Update on 20-May-2021 :
This document was revised to update the section:

• Affected medications: Varenicline, Orphenadrine and Amitriptyline.
• Recalls: Varenicline recalls, Orphenadrine recalls and Amitriptyline recalls

IDRAC_317626_30-Jul-2021_Notice_ Nitrosamine Impurities in Medications, 28-Jul-2021.pdf (1.4 MB)

[MonazBmysorewala]

Hi, Naiffer, May we get Q&A on Nitrosamine referred in this document? I contacted agency, however, not received desire document. Thanking you in anticipation. Regards.

[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…