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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