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Results: 1-10 of 46

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

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

Ontario case on product liability shows the immense scope of a class action trial

  • Torys LLP
  • -
  • Canada
  • -
  • July 5 2012

In a highly anticipated decision released on June 26, 2012, the Ontario Superior Court of Justice ruled in favour of the defendants in Andersen v. St. Jude Medical, Inc., Ontario’s first medical product liability class action trial

Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations

  • Torys LLP
  • -
  • Canada
  • -
  • April 29 2008

On April 26, 2008, the government of Canada published for comment proposed amendments to the Patented Medicines (Notice of Compliance) Regulations, commonly referred to as the “PM(NOC) Regulations.”

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

Canada amends regulations on adverse drug reaction reporting

  • Torys LLP
  • -
  • Canada
  • -
  • March 11 2011

Amended regulations regarding the reporting of adverse drug reactions came into force on February 10, 2011

Ontario drug system reform

  • Torys LLP
  • -
  • Canada
  • -
  • April 12 2010

The Ontario government has published proposed regulatory changes under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act (DIDFA) that will affect the prices paid for generic drugs in both the public and private sector

Innovative drugs sold under the special access programme can receive data protection in Canada

  • Torys LLP
  • -
  • Canada
  • -
  • May 18 2011

To benefit from data protection in Canada, a drug must meet the definition of "innovative drug" under the Food and Drug Regulations

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

Ontario government seeks appeal of pharmacies' successful challenge on private label restrictions

  • Torys LLP
  • -
  • Canada
  • -
  • February 24 2011

The regulation of private label drug products remains in flux with the recent decision of the Ontario Superior Court of Justice (Divisional Court) and potential appeal of that decision