Newsflash: Health Canada Brings Clarification

Health Canada Brings Clarifications to the Data Protection Guidance Document
Catherine Lemay, December 2011

Health Canada recently announced that section 2.1 of its Guidance Document re: Data Protection has been amended to clarify that the prior approval of a medicinal ingredient in a drug for veterinary use will not preclude the granting of data protection for a drug for human use containing the identical medicinal ingredient or a variation thereof and vice versa.  Health Canada has not provided much rationale for its position other than its consistency with the policy intent underlying the 2006 amendments to the data protection provisions and the 1999 Federal Court of Appeal decision in Bayer Inc. v. Canada (Attorney General), 84 C.P.R. (3d) 129, aff’d 87 C.P.R. (3d) 293 which was rendered under the old data protection regime. 

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