Guidance to market authorization holders on issuing health product risk communications.: H164-332/2022E-PDF
"The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs). The guidance provided in this document is limited to HPRCs. An HPRC is a specific type of risk communication generated using the Health Canada-developed HPRC template and standardized process. HPRCs are designed to clearly and effectively communicate information to health care professionals about new health-related risks associated with marketed health products such as: drugs, medical devices, and natural health products. The guidelines and procedures described in this document assume that a decision to issue an HPRC has already been made. This document doesn't describe the criteria used to determine whether an HPRC is the ideal risk communication tool to address a particular risk"--Overview, page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.910380&sl=0
Department/Agency | Canada. Health Canada, issuing body. |
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Title | Guidance to market authorization holders on issuing health product risk communications. |
Publication type | Monograph |
Language | [English] |
Other language editions | [French] |
Format | Electronic |
Electronic document | |
Note(s) | Issued also in French under title: Orientation à l'intention des détenteur d'une autorisation de mise sur le marché concernant la diffusion des communications des risques liés aux produits de santé. "Pub.: 220059." Issued also in HTML format. |
Publishing information | Ottawa, ON : Health Canada = Santé Canada, May 2022. ©2022 |
Description | 1 online resource (iii, 17 pages) : illustration |
ISBN | 9780660431765 |
Catalogue number |
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Departmental catalogue number | 220059 |
Subject terms | Health products -- Government policy -- Canada. Medical supplies -- Government policy -- Canada. Health risk communication -- Government policy -- Canada. |