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03 January 2018
On October 30 2017 Health Canada published the final version of the following guidance documents and templates:
According to the announcement, the guidance documents implement new requirements for new drug submissions and abbreviated new drug submissions, including requirements for stability studies regarding:
The changes will be implemented by way of a phased-in approach, with:
After October 30 2019, a submission must contain at least six months' stability data on at least three primary batches of the drug substance and product.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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