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Results: 1-10 of 46

Changes in the regulation of energy drinks in Canada
  • Torys LLP
  • Canada
  • October 18 2011

On October 6, 2011, Health Canada announced its decision to begin regulating most energy drinks as foods


Health Canada’s guidance document on PM(NOC) Regulations now finalized
  • Torys LLP
  • Canada
  • April 4 2012

Health Canada has published an update to its guidance document on the application of the Patented Medicines (Notice of Compliance) Regulations


Classifying patient management software in Canada
  • Torys LLP
  • Canada
  • June 8 2010

Health Canada has clarified the approach taken by its Medical Devices Bureau to classify patient management software as either a Class I or a Class II medical device


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


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


Canada's approach to functional foods
  • Torys LLP
  • Canada
  • April 21 2010

Today’s diet- and health-conscious environment has led to a proliferation of functional food marketing claims that advertise the specific health-enhancing characteristics of a food product


Canada's version of the responsible corporate officer doctrine: can officers be held responsible for pharma violations?
  • Torys LLP
  • Canada, USA
  • February 29 2012

In March 2010, the United States Food and Drug Administration (FDA) announced its intention to rely more heavily on the "responsible corporate officer" (RCO) doctrine to prosecute individuals for violations of the federal Food, Drug and Cosmetic Act (FDCA


Considerations for medical device software companies entering the Canadian market
  • Torys LLP
  • Canada
  • July 25 2011

Canada has one of the world’s largest medical device markets, estimated at C$6 billion in 2010, with sales of almost C$3 billion taking place in Ontario


Biosimilars in Canada: new draft guidelines from Health Canada
  • Torys LLP
  • Canada
  • July 21 2009

Health Canada announced that it had granted marketing authorization for Omnitrope (a human growth hormone), the first subsequent entry biologic (SEB) to be approved for sale 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).”