Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (English, HTML)

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HTML

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Publisher-reported update

2021-07-05

Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require the granting of protection for undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical product which utilizes a new chemical entity, the origination of which involved considerable effort.

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