Canada

Food and Drug Regulations

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 (Version with Automatic Translation Tool)
French	Règlement sur les aliments et les drogues
Related Legislation:	Relates to Food and Drugs Act (R.S.C., 1985, c. F-27) (CA084) Is amended by Regulations Amending the Food and Drugs Regulations (Data Protection) (CA052)
Historical Versions:	Is superseded by Food and Drug Regulations (C.R.C., c. 870) (CA122)
WIPO Lex No.:	CA029