000 01714nam  2200277za 4500
0019.801456
003CaOODSP
00520221107134813
007cr |||||||||||
008160415s2015    onc     o    f000 0 eng d
020 |a978-0-660-02634-3
040 |aCaOODSP|beng
043 |an-cn---
0861 |aH164-187/2015E-PDF
1101 |aCanada. |bHealth Products and Food Branch.
24510|aGuidance document |h[electronic resource] : |bsubmission of risk management plans and follow-up commitments.
260 |aOttawa : |bHealth Canada, |c2015.
300 |aiii, 17 p.
500 |aIssued also in French under title: Présentation des plans de gestion des risques et des engagements en matière de suivi.
500 |a“Effective Date: June 26, 2015.”
520 |a"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.
69207|2gccst|aDrugs
69207|2gccst|aRisk management
69207|2gccst|aGuidelines
77508|tLigne directrice |w(CaOODSP)9.801458
85640|qPDF|s226 KB|uhttps://publications.gc.ca/collections/collection_2016/sc-hc/H164-187-2015-eng.pdf