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.

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Publication information
Department/Agency Canada. Health Canada, issuing body.
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
  • H164-332/2022E-PDF
Departmental catalogue number 220059
Subject terms Health products -- Government policy -- Canada.
Medical supplies -- Government policy -- Canada.
Health risk communication -- Government policy -- Canada.
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