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Promotion of drugs and devices at international conferences held in Canada

Torys LLP
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Canada
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February 3 2009

As a neighbor, Canada is often selected as a venue for international conferences of U.S. drug and device manufacturers

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

Torys LLP
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Canada
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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 proposes amending the Food and Drugs Act and creating consumer product safety legislation

Torys LLP
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Canada
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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
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Canada
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May 27 2008

Health Canada has released a draft guidance document entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEBs).”

Canada’s Federal Court of Appeal limits damages available to delayed generics

Torys LLP
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Canada
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June 8 2009

On June 4, 2009, in Merck Frosst Canada Inc. v. Apotex, Inc., the Federal Court of Appeal released an important decision limiting the range of damages available in actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations

Canada proposes amendments to adverse drug reaction reporting

Torys LLP
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Canada
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June 18 2009

On June 13, 2009, proposed regulations amending the Food and Drug Regulations with respect to adverse drug reaction reporting (Proposed Regulations) were published in the Canada Gazette

Amendments to the Patented Medicines (Notice of Compliance) Regulations now in force

Torys LLP
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Canada
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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

Draft guidelines on subsequent entry biologics

Torys LLP
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Canada
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February 15 2008

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

Classifying medical device software in Canada

Torys LLP
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Canada
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March 12 2010

Health Canada has indicated that it plans to release an updated notice on classifying patient management software in the coming weeks, modifying the notice it released on August 31, 2009

Canadian privacy commissioners release guidance on workplace H1N1 privacy

Torys LLP
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Canada
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November 18 2009

On October 29, 2009 the Office of the Privacy Commissioner of Canada (OPC), together with the Privacy Commissioners’ offices of Alberta and British Columbia, published a guidance document titled "Privacy in the Time of a Pandemic: Guidance for Organizations."

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