Canada amends market authorization for 'extraordinary use new drugs'
The government of Canada has introduced amendments to the Food and Drug Regulations and the Patented Medicines (Notice of Compliance) Regulations which provide an application process for the market authorisation and protection of “extraordinary use new drugs (EUNDs). These amendments, which took effect on March 25, are explained by law firm Norton Rose in a posting on the web site of the International Law Office.
Background
EUNDs are used to treat, mitigate or prevent life-threatening or serious health conditions in humans which result from exposure to a chemical, biological, radiological or nuclear substance in an emergency situation such as a pandemic or terrorist attack.
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