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Results: 1-10 of 46

Proposed amendment would exempt some generic submissions from Canada’s PM(NOC) regulations

  • Torys LLP
  • -
  • Canada
  • -
  • October 4 2011

Health Canada has released a proposed amendment to its guidance document Patented Medicines (Notice of Compliance) Regulations

Federal Court of Canada grants data protection to an old medicinal ingredient

  • Torys LLP
  • -
  • Canada
  • -
  • February 14 2012

In a recent decision Celgene Inc. v. Canada (Minister of Health) the Federal Court of Canada declared that a drug containing a previously approved medicinal ingredient is nevertheless subject to data protection

Doing a deal with pharma

  • Torys LLP
  • -
  • Canada
  • -
  • August 4 2011

From the perspective of the biotech company, there are several legal and business issues to consider when doing a deal with big pharma

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

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

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.”

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

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

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