Sara Zborovski (CA)

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Ontario introduces legislation requiring disclosure of payments to physicians

By Ian Trimble (CA) and Sara Zborovski (CA) on October 6, 2017 Posted in International

Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers, wholesalers, marketing firms, and others … Continue reading

Ontario announces sales of recreational cannabis framework

By Sara Zborovski (CA) on September 14, 2017 Posted in International

On September 8th, Ontario announced its much-anticipated framework for the distribution and sale of recreational cannabis. This announcement makes Ontario the first province to outline a comprehensive response to the Federal government’s plan to legalize cannabis by July 2018. Ontario’s proposed approach largely mirrors the Province’s approach to the sale of alcohol and tobacco. Recreational … Continue reading

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

By Jillian Hyslop (CA) and Sara Zborovski (CA) on June 21, 2017 Posted in International

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling Regulations.” As of June 13, 2017, the Plain … Continue reading

Canada’s legalization of recreational cannabis – legislation introduced

By Sara Zborovski (CA) and Ian Trimble (CA) on April 18, 2017 Posted in Regulatory

In the 2015 Federal election, the Liberal Party of Canada ran on a platform that included the legalization of recreational cannabis. Following the election, a task force was created to report on legalization and regulation, and a report was delivered in November 2016. On April 13, 2017, Bill C-45, An Act respecting cannabis and to … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

By Ian Trimble (CA), Kristin Wall (CA) and Sara Zborovski (CA) on April 6, 2017 Posted in FDA & Food Safety, International

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

By Jillian Hyslop (CA) and Sara Zborovski (CA) on February 1, 2017 Posted in FDA & Food Safety, International

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading

New proposed food safety regulations open for comments

By Sara Zborovski (CA) on January 31, 2017 Posted in FDA & Food Safety

They’re finally here! The long-awaited Safe Food for Canadians Regulations have been pre-published in the Canada Gazette I for comment, and the CFIA has officially kicked off consultation on the proposed regulations. The proposed Regulations are made under the Safe Food for Canadians Act (the “Act”), which was adopted back in 2012 with a view … Continue reading

Biologics: what’s in a name? Health Canada and EMA take a different approach from FDA

By Sara Zborovski (CA) and Ian Trimble (CA) on January 20, 2017 Posted in Regulatory

Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core name and a meaningless four-letter suffix. This is an important divergence from the practice in Canada … Continue reading

Sugar, Salt and Fat : the Usual Suspects Targeted by Health Canada’s Proposed Mandatory Front-Of-Package Labelling System

By Sara Zborovski (CA) on December 14, 2016 Posted in FDA & Food Safety

Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health Eating Strategy, announced on October 24, 2016. A public consultation was launched on November 14, … Continue reading

U.S. Food and Drug Administration announces new partnership with Canadian Food Inspection Agency on food safety

By Sara Zborovski (CA) and Jillian Hyslop (CA) on June 13, 2016 Posted in FDA & Food Safety

Summary On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as … Continue reading