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21 August 2019
On 10 June 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.(1) Once the amendments are in force on 16 December 2019, all hospitals will be obliged 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 26 June 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.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) Updated chart is available here.
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