00000nam 2200000zi 4500 9.874301 CaOODSP 20221107164144 m o d f cr ||||||||||| 190723e201906##onc o f000 0 eng d 9780660312163 CaOODSP eng rda CaOODSP n-cn--- H164-280/2019E-PDF Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals : guidance document. [Ottawa] : Health Canada = Santé Canada, June 2019. ©2019 1 online resource (iv, 40 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Déclaration obligatoire des réactions indésirables graves à un médicament et des incidents liés aux instruments médicaux par les hôpitaux : document d’orientation. Issued also in HTML format. "The purpose of this guidance document is to provide hospitals with information that may be useful in achieving compliance with the federal regulatory requirement for hospitals to report serious ADRs and MDIs to Health Canada as outlined in section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical DeviceRegulations"--Objective, page 1. gccst Health care facilities gccst Side effects gccst Legislation Canada. Health Canada. Déclaration obligatoire des réactions indésirables graves à un médicament et des incidents liés aux instruments médicaux par les hôpitaux : (CaOODSP)9.874303 PDF 610 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H164-280-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices.html 190097