This new law came into force on November 6, 2014. It amends the Food and Drugs Act and applies to therapeutic prescription products and OTC as well as medical devices. It does not apply to natural health products.
Vanessa’s Law grants new powers to Health Canada for the monitoring of marketed products. Health Canada will be able, among others, to require recall of unsafe products, extend the obligation of reporting adverse reaction to some healthcare institutions, require products labels review and order new clinical trials. Sanctions will now be applicable to people and may include imprisonment and maximum fines of 5 million dollars. These penalties can be increased at the discretion of the court, on a case by case basis.
Please do not hesitate to contact us for more information regarding this new law and its consequences.
