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Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements

On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the region.vanessas-law-canada

While the new law includes a host of regulations that enable the government to pull unsafe products off the market and impose severe penalties to those who don’t comply, it also creates new reporting requirements for serious adverse events (SAEs).

Since many users of prescription drugs who experience SAEs require hospitalization, certain healthcare institutions, such as hospitals and clinics, are now required to report them to Health Canada, the government’s agency that oversees the safety of pharmaceutical, medical device and natural health products. In the coming weeks and months, these organizations will need to institute new processes and mechanisms to meet these demands.

To read about the new regulations in more detail, visit:

Overview on Health Canada

Full version of the law

And for those wondering why it’s called Vanessa’s Law – it’s named after a Canadian parliament member’s daughter, who died of a heart attack while on a prescription drug that later was later taken of the market.

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Eugene Sefanov

Director, Industry and Regional Marketing

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