00000nam 2200000za 4500 9.801456 CaOODSP 20221107134813 cr ||||||||||| 160415s2015 onc o f000 0 eng d 978-0-660-02634-3 CaOODSP eng n-cn--- H164-187/2015E-PDF Canada. Health Products and Food Branch. Guidance document [electronic resource] : submission of risk management plans and follow-up commitments. Ottawa : Health Canada, 2015. iii, 17 p. Issued also in French under title: Présentation des plans de gestion des risques et des engagements en matière de suivi. “Effective Date: June 26, 2015.” "Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. ... This document provides the sponsor/market authorization holder (MAH) with guidance on how to proceed when submitting a Canadian RMP in the European Union (EU) format or other recognized formats (e.g., United States (US) Risk Evaluation and Mitigation Strategy [REMS]), as well as RMP follow-up commitments and updates with Health Canada"--p. i and p. 1. gccst Drugs gccst Risk management gccst Guidelines Ligne directrice (CaOODSP)9.801458 PDF 226 KB https://publications.gc.ca/collections/collection_2016/sc-hc/H164-187-2015-eng.pdf 150031