🇨🇦 Health Canada extended deadline?

Guidance, Documents, Resources
1

I learned through a LinkedIn post today that Health Canada might have extended the deadline to complete Steps 1-3 to August 1st, 2025 ?? I checked the last revision from their guideline, but no no time extension is mentioned. I was also told that MAHs were informed by direct communication.

Can you confirm the extension to August, 1st 2025? Is it a wide adoption or only to certain cases, perhaps medication of critical access?

Thanks for your input!

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2

Considering the ongoing challenges MAHs may face, the timelines for completing Step 3 have been extended to August 1, 2025. This extension applies to drug products containing chemically synthesized and semi-synthetic APIs, and to biological and radiopharmaceutical drug products. This extension applies to all nitrosamine impurities. The timelines for completing Step 2 (confirmatory testing) remain unchanged. MAHs requiring additional time to complete Step 2 should still submit a formal request for extension as indicated in Health Canada’s Guidance on nitrosamine impurities in medications. Guidance will soon be updated to reflect the extension of the Step 3 timeline.

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3

@hgajjar Thanks for sharing the information

4

Thanks for your valuable updates.

5

Please review the new post about the guideline update… deadlines has been extended to 2025

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