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Article: Court Upholds Data Exclusivity Rules For Pharmaceutical Manufacturers.(data protection and trade regulations)
- Article from:
- Mondaq Business Briefing
- Article date:
- July 27, 2009
CopyrightCOPYRIGHT 2009 Mondaq Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The Federal Court, in a decision released on July 17, 2009, has upheld Canada's Food and Drug Regulations as they relate to the protection of data that is submitted by innovators for the purpose of obtaining regulatory approval (the Data Protection Regulations).
Currently, the Data Protection Regulations, implemented on October 5, 2006, provide a period of 8 years of protection from the date of an innovator's first Notice of Compliance for an "innovative drug", and the possibility of a further 6 month period if studies are conducted in the pediatric population. During the period of protection, no competing manufacturer can compare its product to the innovative ...