Issuing Hprc Health Canada
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Guidance to market authorization holders on issuing health - ca…
(6 days ago) People also askHow do Health Canada hprcs work?HPRCs are coordinated through a centralized process at Health Canada. The Marketed Health Product Directorate's Risk Communication Section (RCS) administers this process. Once Health Canada's lead directorate and the MAH have decided to issue an HPRC, MAHs should address all HPRC-related correspondence to the risk communications project manager.Guidance to market authorization holders on issuing health product risk canada.caWhat are hprcs & how do they work?HPRCs are designed to promote a consistent approach to communicating the most accurate, relevant and complete information about a risk issue. This approach is supported by a standardized HPRC template, as well as a collaborative process involving both Health Canada and MAHs, to develop and disseminate HPRCs.Guidance to market authorization holders on issuing health - canada.cacanada.caWho is responsible for developing and disseminating hprcs?This document focuses on the role of MAHs and Health Canada, who are jointly responsible for developing and disseminating HPRCs. An MAH has a responsibility to inform Health Canada if it becomes aware of the need to issue an HPRC, as a result of new or emerging risk information either in Canada or internationally.Guidance to market authorization holders on issuing health product risk canada.caDoes Health Canada have a right to request information or material?As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.Guidance to market authorization holders on issuing health - canada.cacanada.caFeedbackCanada.cahttps://www.canada.ca/en/health-canada/services/Guidance to market authorization holders on issuing healthAn MAH has a responsibility to inform Health Canada if it becomes aware of the need to issue an HPRC, as a result of new or emerging risk information either in Canada or internationally. Prior to the HPRC development process, the MAH should engage in discussions with the appropriate lead directorate within Health … See more
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Guidance to market authorization holders on issuing health
(6 days ago) WEBAn HPRC is a type of risk communication designed by Health Canada to assist MAHs communicate clinically significant health product risk information to the broader health …
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Guidance to market authorization holders on issuing health
(6 days ago) WEBThe RCS will work with MAHs to develop a critical path for each HPRC, on a case-by-case basis, based on the level of urgency. To help MAHs visualize the …
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Guidance to market authorization holders on issuing health
(8 days ago) WEBHealth product risk communication (HPRC): An HPRC is a type of risk communication designed by Health Canada to help MAHs communicate new and …
Category: Health Show Health
Guidance to market authorization holders on issuing health
(7 days ago) WEBCopies of any risk communications issued within Canada or foreign jurisdictions that are related to the issue ; HPRC dissemination strategy (distribution list …
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Guidance to market authorization holders on issuing health …
(1 days ago) WEBGuidance to market authorization holders on issuing health product risk communications.: H164-332/2022E-PDF An HPRC is a specific type of risk communication generated …
https://publications.gc.ca/site/eng/9.910380/publication.html
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Guidance to market authorization holders on issuing health …
(2 days ago) WEBThe timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a health product. Current Organization Name: …
https://open.canada.ca/data/en/info/77966866-d218-4a68-aaa4-f42378192418
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Guidance to market authorization holders on issuing health …
(2 days ago) WEBPublisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada; Data and Resources Guidance to market authorization …
https://open.canada.ca/data/en/info/88ea2b0a-c4e7-466b-ad03-19bb5e5d54f5
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About - Drug and Health Product Register
(5 days ago) WEBThe DHPR was created to make information on health products available to Canadians. The information in the DHPR has always been publically available, but it was previously …
https://hpr-rps.hres.ca/static/content/about-propos.php
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Guide for using the Standardized Health Product - Minister of …
(5 days ago) WEBPurpose. This guide is intended to assist in the drafting of risk communications, using the standardized template to communicate health product safety …
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Standardized Health Product Risk Communication Template
(9 days ago) WEBAction taken by Health Canada. Text describing any risk management measures (e.g., [specific section] of the product monograph will be updated to reflect the …
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Important Safety Update on XELJANZ /XELJANZ XR …
(5 days ago) WEBreceiving XELJANZ/XELJANZ XR should be reported to Pfizer Canada ULC or Health Canada. Sincerely, Vratislav Hadrava M.D., Ph.D. Vice President & Medical Director …
https://www.pfizer.ca/files/XELJANZ_HPRC_Final_EN_12-Jan-2022.pdf
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Health Canada updates guidance on switching of a medicinal
(5 days ago) WEBFor switches to NPDs, Health Canada will issue a Drug Notification Form with the assigned DIN if applicable, and a NOC. For switches to NHPs, applicants must …
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2022/01/17 Healthcare professionals including physicians
(4 days ago) WEBWhat is the issue? PAXLOVID (nirmatrelvir and ritonavir) was authorized by Health Canada on January 17, 2022. PAXLOVID is not recommended in patients with severe …
https://www.pfizer.ca/files/Final_PAXLOVID-HPRC_17Jan2022_EN.pdf
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Guidance to market authorization holders on issuing health …
(5 days ago) WEBOnce Health Canada’s lead directorate and the MAH have decided to issue an HPRC, MAHs should address all HPRC-related correspondence to the risk communications …
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Sotrovimab (sotrovimab) COVID-19 vaccines and treatments portal
(8 days ago) WEBHealth Care Professionals, Researchers : Authorization Terms & Conditions: For COVID-19 authorizations, Health Canada can impose specific terms and conditions on the …
https://covid-vaccine.canada.ca/sotrovimab/product-details
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Canada Issues Final Rule Updating Hazardous Products
(7 days ago) WEBBy Phil Molé, MPH. 2023 is off to a quick start for new EHS regulations! Health Canada has just published a final rule to update its Hazardous Products …
https://www.ehs.com/2023/01/canada-issues-final-rule-updating-hazardous-products-regulations-hpr/
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Health Canada - Canada.ca
(3 days ago) WEBHealth Canada. Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to …
https://www.canada.ca/en/health-canada.html
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Guidance Document
(2 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …
https://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-eng.pdf
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Important Safety Information on ZEJULA (niraparib) - Update …
(2 days ago) WEBReport health or safety concerns Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and …
https://ca.gsk.com/media/6974/1383-zejula_niraparib-hprc_final_osb_20230213-en.pdf
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Guidance Document
(2 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …
https://publications.gc.ca/collections/collection_2024/sc-hc/H164-292-2024-eng.pdf
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TERMS AND CONDITIONS - COVID-19 vaccines and …
(8 days ago) WEB22 Novovax Inc. is requested to develop and distribute a Health Product Risk Communication (HPRC), in French and English, should a decision be made to import, …
https://covid-vaccine.canada.ca/info/pdf/nuvaxovid-authorisation.pdf
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Health Canada warns that Power-7 USB Wall Charger Model …
(2 days ago) WEBThe product has been removed from sale from Amazon.ca. Health Canada has contacted the foreign third-party seller and is advising consumers to immediately …
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Unauthorized UMARY Hyaluronic Acid Dietary Supplement …
(6 days ago) WEBDiclofenac for oral consumption is a prescription non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and swelling caused by arthritis. It …
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