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Results: 1-10 of 46

Canada proposes amending the Food and Drugs Act and creating consumer product safety legislation
  • Torys LLP
  • Canada
  • May 2 2008

On April 8, 2008, the federal government tabled legislation in the House of Commons to amend the Food and Drugs Act and to introduce new consumer product safety legislation in Canada


Follow-on biologics in Canada: a look at the new draft guidelines
  • Torys LLP
  • Canada
  • May 27 2008

Health Canada has released a draft guidance document entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEBs).”


Court affirms Health Canada’s broad discretion in review of drug submissions
  • Torys LLP
  • Canada
  • April 13 2010

In a recent decision of the Federal Court in Hospira Healthcare Corporation v. Canada (Attorney General) the Court affirmed that Health Canada has broad discretion in interpreting the Food and Drug Regulations to determine the content of an application for the marketing approval of a drug


Draft guidelines on subsequent entry biologics
  • Torys LLP
  • Canada
  • February 15 2008

Health Canada has released a draft guidance document titled “Information and Submission Requirements for Subsequent Entry Biologics (SEBs).”


Ontario court confirms generic drug manufacturers not entitled to unjust enrichment
  • Torys LLP
  • Canada
  • January 22 2013

On January 15, 2013, the Ontario Superior Court of Justice (Ontario Court) granted a motion for partial summary judgment in Apotex Inc. v. Abbott


Producers to manage pharmaceuticals and sharps returned by consumers
  • Torys LLP
  • Canada
  • November 2 2012

On October 1, 2012, Collection of Pharmaceuticals and Sharps Responsibilities of Producers regulation (O. Reg. 29812) came into force


Health Canada to list authorized clinical trials online
  • Torys LLP
  • Canada
  • October 25 2012

On October 18, 2012, Health Canada issued a news release and subsequent Drugs and Health Products Notice announcing that it will create a web-based list of clinical trials authorized by Health Canada


Canada’s PAAB releases updated Code of Advertising Acceptance
  • Torys LLP
  • Canada
  • December 7 2012

The Pharmaceutical Advertising Advisory Board (PAAB) has released a revised version of its Code of Advertising Acceptance


Data protection in Canada: Court of Appeal confirms narrow approach
  • Torys LLP
  • Canada
  • January 30 2013

On January 18, 2013, the Federal Court of Appeal (FCA) released its decision in Takeda Canada Inc. v. The Minister of Health and Attorney General of


Amendments to the Patented Medicines (Notice of Compliance) Regulations now in force
  • Torys LLP
  • Canada
  • June 13 2008

On June 12, 2008, amendments to the Patented Medicines (Notice of Compliance) Regulations (commonly referred to as the “PM(NOC) Regulations”) came into force