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| 02708cam 2200373zi 4500 |
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001 | 9.910380 |
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003 | CaOODSP |
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005 | 20220913092743 |
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006 | m o d f |
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007 | cr mn||||||||| |
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008 | 220420e202205 onca o f000 0 eng d |
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020 | |a9780660431765 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH164-332/2022E-PDF |
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245 | 00|aGuidance to market authorization holders on issuing health product risk communications. |
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264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cMay 2022. |
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264 | 4|c©2022 |
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300 | |a1 online resource (iii, 17 pages) : |billustration |
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336 | |atext|btxt|2rdacontent |
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337 | |acomputer|bc|2rdamedia |
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338 | |aonline resource|bcr|2rdacarrier |
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500 | |aIssued 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. |
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500 | |a"Pub.: 220059." |
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500 | |aIssued also in HTML format. |
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520 | |a"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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650 | 0|aHealth products|xGovernment policy|zCanada. |
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650 | 0|aMedical supplies|xGovernment policy|zCanada. |
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650 | 0|aHealth risk communication|xGovernment policy|zCanada. |
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710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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775 | 08|tOrientation 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.|w(CaOODSP)9.910381 |
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856 | 40|qPDF|s1.30 MB|uhttps://publications.gc.ca/collections/collection_2022/sc-hc/H164-332-2022-eng.pdf |
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856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-market-authorization-holders-on-issuing-health-product-risk-communications.html |
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