On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were published. These amendments were enacted further to Vanessa’s Law (see updated chart). Once the amendments are in force on December 16, 2019, all hospitals will be obligated to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital. On June 26, 2019, Health Canada announced these new reporting requirements, and published Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview to provide information on how to comply with the requirements.
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