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Proposed new regulations for hospital reporting of serious adverse drug reactions and medical device incidents

Authored byUrszula Wojtyra

On June 15, 2018, Health Canada announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals) and the Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals). The regulations specify that for the purposes of section 21.8 of the Food and Drugs Act, as amended by Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), hospitals are the prescribed health care institutions that shall provide information in their control to the Minister of Health. Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents (as defined in the proposed amendments) directly to Health Canada within 30 days of first documenting the reaction or incident in the hospital. The reporting requirements apply to pharmaceuticals (prescription and non-prescription), biologic drugs (excluding vaccines that are part of a routine immunization program), radiopharmaceuticals, disinfectants and medical devices, but exclude these products when used in clinical trials or as part of the Special Access Programme. The consultation period ends on August 30. We have updated our previously published chart (An Update on Vanessa’s Law) to include these proposed regulations.