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Suppliers beware when warranting design

Fasken Martineau DuMoulin LLP
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Canada
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November 26 2012

The recent British Columbia Court of Appeal case of Greater Vancouver Water District v. North American Pipe & Steel Ltd. provides a very good reminder to suppliers of the risks of providing warranties in supply contracts

“Keeping up with the joneses”: proposed amendment to the food and drug regulations seeks to extend good manufacturing practices requirements to all active ingredients

Fasken Martineau DuMoulin LLP
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Canada
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October 10 2012

An amendment to the Food and Drug Regulations has been proposed that would extend the good manufacturing practices requirements for drugs to all active ingredients (AI); extend drug establishment licensing requirements to those carrying out various activities involving AI; and create a new record-keeping requirement to facilitate the ability to trace AI from the original fabricator to the dosage-form drug manufacturer

Health Canada issues updated compliance and enforcement guidelines for medical devices

Fasken Martineau DuMoulin LLP
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Canada
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September 13 2012

On August 10, 2012, Health Canada released an updated Guidance on Medical Device Compliance and Enforcement (GUI-0073) to provide the medical device industry with a clearer description of compliance and enforcement actions relating to the Medical Devices Regulations and applicable sections of the Food and Drugs Act

Improper use of procedure in the class action against cigarette manufacturers: sanctions for disproportionate use of the rules of evidence

Fasken Martineau DuMoulin LLP
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Canada
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May 15 2012

The historic class action brought by the Quebec Council on Tobacco and Health against cigarette manufacturers JTI-Macdonald, Imperial Tobacco, and Rothmans Benson & Hedges began in March

What’s old can be new again: thalidomide is considered “innovative”

Fasken Martineau DuMoulin LLP
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Canada
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March 14 2012

The Federal Court of Canada has recently held that a drug previously approved in Canada, but withdrawn for safety reasons, could later qualify as an "innovative drug"

Show us what you’re made of proposed amendment to the food and drug regulations

Fasken Martineau DuMoulin LLP
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Canada
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November 1 2011

An amendment to the Food and Drug Regulations has been proposed that would apply to drugs regulated solely under Part C, Division 1 (i.e., drugs that have been sold in Canada for a sufficient time and in sufficient quantity to establish safety and effectiveness -- "Division 1 drugs"

An eyesore no more proposed legislation to classify cosmetic contact lenses as Class II medical devices

Fasken Martineau DuMoulin LLP
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Canada
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October 26 2011

On October 3, Bill C-313, An Act to Amend the Food and Drugs Act (Non-Corrective Cosmetic Contact Lenses) was introduced in Parliament

Administrative drug submissions to be excluded from the PM(NOC) regulations?

Fasken Martineau DuMoulin LLP
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Canada
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October 14 2011

Health Canada recently released proposed revisions to its Patented Medicines (Notice of Compliance) Regulations guidance document that, if implemented, will exclude certain administrative drug submissions (e.g., where a licensee cross-references a licensor's drug submission) from the scope of section 5 of the PM(NOC) Regulations

Canada Consumer Product Safety Act: mandatory product recall bill finally becomes law

Fasken Martineau DuMoulin LLP
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Canada
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December 15 2010

Almost 3 years to the day that Prime Minister Stephen Harper first announced his Food and Consumer Product Safety Action Plan proposing a series of initiatives to modernize and strengthen Canada's safety system for food, health and consumer products, Bill C-36, the Canada Consumer Product Safety Act (CCPSA), was finally passed by the Canadian Senate on December 13, 2010

New incident reporting obligations under the Canada Consumer Product Safety Act (Bill c-36)

Fasken Martineau DuMoulin LLP
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Canada
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November 19 2010

When enacted, section 14 of the Canada Consumer Product Safety Act (CCPSA) will require each supplier, regardless as to whether the supplier is the manufacturer, the importer, the distributor or the retailer of the consumer product in Canada, to report to the Minister of Health (and to the person, if any, who supplied the product to such supplier) all information in its control regarding any "incident" related to such consumer product within two days of such supplier becoming aware of the incident