00000nam 2200000za 4500 9.856242 CaOODSP 20221107155508 cr ||||||||||| 180507s2018 onc ob f000 0 eng d 978-0-660-26506-3 CaOODSP eng n-cn--- H164-235/2018E-PDF Preparing and submitting summary reports for marketed drugs and natural health products [electronic resource] : guidance document for industry. Guidance document for industry Ottawa : Health Canada, 2018. iii, 25 p. "Effective Date: May 23, 2018." Title from cover. "Your health and safety ... our priority." "MedEffect Canada. Together we can improve health product safety." The copy has been replaced on January 21, 2022 as requested by the issuing department. Issued also in French under title: Préparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés : document d’orientation à l’intention de l’industrie. Includes bibliographical references. "This guidance document provides market authorization holders (MAHs) with information on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to preparing and submitting annual summary reports (ASRs) and issue-related summary reports (IRSRs)"--Scope and Application, p. 1. gccst Products gccst Reports gccst Industrial policy Canada. Health Canada. Préparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés (CaOODSP)9.856244 PDF 1.18 MB https://publications.gc.ca/collections/collection_2018/sc-hc/H164-235-2018-eng.pdf Pub.: 180054