Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product (French, HTML)

View metadata and access the original French HTML file: Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product.

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Publisher-reported update

2023-09-01

To provide sponsors of an Abbreviated New Drug Submission or an Abbreviated Extraordinary Use New Drug Submission who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a reference drug under paragraph (c) of the definition of Canadian reference product (CRP) in C.08.001.1 of the Food and Drug Regulations with guidance on how they may demonstrate that this reference drug is acceptable to the Minister as a CRP.

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