World Intellectual Property Organization

Canada

Food and Drug Regulations

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Canada

Year of current version:2011
Date of Text (Issued):1978
Type of Text:Implementing Rules/Regulations
Subject Matter:Enforcement of IP and Related Laws, Industrial Property, Other, Patents (Inventions), Trade Names, Trademarks, Undisclosed Information (Trade Secrets)
Notes:The notification by Canada to the WTO under Article 63.2 of TRIPS states:
'Schedule 843 provides that where a manufacturer files a new drug submission (NDS) for the pharmaceutical or biological equivalent of a Canadian reference product, in reliance upon data contained in the material files by the innovator, the Minister shall not issue a notice of compliance (NOC, i.e. , marketing approval) for the NDS until five years after the date of issuance of the innovator's NOC.'
Available Texts: 
English

Food and Drug Regulations Food and Drug Regulations, Complete document (pdf) [1915 KB] Food and Drug Regulations, Complete document (htm) [7466 KB] (Version with Automatic Translation Tool)

French

Règlement sur les aliments et les drogues Règlement sur les aliments et les drogues, Complete document (pdf) [2102 KB]

Related Legislation:
WIPO Lex No.:CA029

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