Health Canada Hprc Review

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Guidance to market authorization holders on issuing …

(7 days ago) Health Canada and the MAH review the HPRC and dissemination strategy until both parties agree with the final drafts. The MAH is responsible for translating the HPRC and providing signed copies of the final HPRC to Health Canada. The third part of the HPRC process is the "dissemination, notification and … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-market-authorization-holders-on-issuing-health-product-risk-communications/roles-responsibilities-process.html

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Guidance to market authorization holders on issuing …

(6 days ago) WEBThe purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs). Scope. The guidance …

https://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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Guidance to market authorization holders on issuing …

(7 days ago) WEBHPRC dissemination strategy (distribution list and method of dissemination) Phase 2: Review and approval. Subsequent draft HPRCs with MAH edits; Translation of …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-market-authorization-holders-on-issuing-health-product-risk-communications/submission-checklist.html

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Guidance to market authorization holders on issuing …

(1 days ago) WEBAn HPRC is a specific type of risk communication generated using the Health Canada-developed HPRC template and standardized process. HPRCs are designed to clearly …

https://publications.gc.ca/site/eng/9.910380/publication.html

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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 Regulations (HPR) to align with the seventh …

https://www.ehs.com/2023/01/canada-issues-final-rule-updating-hazardous-products-regulations-hpr/

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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 …

https://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2015-temp-mod_rc-cr-eng.php

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Health Canada's Proposal to Accelerate New Drug Reviews

(3 days ago) WEBHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug Submissions” …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/

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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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Guidance to market authorization holders on issuing …

(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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2022/01/17 Healthcare professionals including …

(4 days ago) WEBHealth Canada is communicating this important safety information to healthcare professionals and Canadians via the . Recalls and Safety Alerts Database on the …

https://www.pfizer.ca/files/Final_PAXLOVID-HPRC_17Jan2022_EN.pdf

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Sotrovimab (sotrovimab) COVID-19 vaccines and treatments portal

(8 days ago) WEB11 rows · For COVID-19 authorizations, Health Canada can impose specific terms and conditions on the authorization. This allows Health Canada to continue to gather …

https://covid-vaccine.canada.ca/sotrovimab/product-details

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Important Safety Information on ZEJULA (niraparib) - Update …

(2 days ago) WEBAction taken by Health Canada Health Canada will review all available information that will be submitted by GSK and further communicate if any action is …

https://ca.gsk.com/media/6974/1383-zejula_niraparib-hprc_final_osb_20230213-en.pdf

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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 …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-market-authorization-holders-on-issuing-health-product-risk-communications/timelines.html

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REP Templates for Health Canada

(2 days ago) WEBCompany (CO) Template (updated 2023-02-28) Required to obtain a company ID and/or update company information to Health Canada. Sent via email. Attach draft CO XML file …

https://health-products.canada.ca/rep-pir/index.html

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Health Professions Appeal and Review Board

(1 days ago) WEBThe Board recommends that all requests for review, submissions, materials, and inquiries be sent via email to [email protected] or faxed to HPARB at 416-327-8524. …

https://www.hparb.on.ca/scripts/english/default.asp

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Health Canada Offers HTA-Aligned Reviews for Drugs and Biologics

(Just Now) WEBHealth Canada Offers HTA-Aligned Reviews for Drugs and Biologics. Regulatory NewsAna Mulero. Sponsors of biologics and new drug submissions now have the option of …

https://www.raps.org/news-and-articles/news-articles/2018/6/health-canada-offers-hta-aligned-reviews-for-drugs

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Niraparib (Zejula) for Ovarian Cancer - Details CDA-AMC - CADTH

(Just Now) WEB100 mg. Tumour Type: Gynecology. Indications: Ovarian Cancer. Funding Request: As monotherapy for the maintenance treatment of female adult patients with …

https://www.cadth.ca/niraparib-zejula-ovarian-cancer-details

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Health Canada's Proposal to Accelerate New Drug Reviews

(1 days ago) WEBPMCID: PMC7294445. DOI: 10.12927/hcpol.2020.26227. Abstract. in English, French. Health Canada is proposing to update its accelerated review pathways to get important …

https://pubmed.ncbi.nlm.nih.gov/32538346/

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What is HPRC? What is HPO? - MCU

(Just Now) WEBHPRC is aligned under Force Health Protection and Readiness and is the educational arm of the Consortium for Health and Military Performance (CHAMP) at the …

https://www.usmcu.edu/Portals/218/LLI/MLD/Fitness/PDF_What%20is%20HPRC.pdf?ver=2018-09-26-100153-693

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Health and Biosciences: Targeted Regulatory Review - canada.ca

(3 days ago) WEBLast update: January 2021. The Health and Biosciences Sector Regulatory Review Roadmap outlines Health Canada's plan to address the issues, irritants, and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review/roadmap.html

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Canada's new cancer figures reflect a mixed message: study

(6 days ago) WEBCancer is the leading cause of premature death, researchers said in Monday's issue of the Canadian Medical Association Journal. It also accounted for 25 per cent of …

https://www.cbc.ca/news/health/cancer-cmaj-may-1.7200589

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Canada's foreign student push 'mismatched' job market, data shows

(8 days ago) WEBCanada’s recruitment of international students has tilted strongly toward filling spots in business programs, while doing little to meet the demand for workers in …

https://www.cbc.ca/news/canada/toronto/international-students-college-university-fields-study-data-1.7195530

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Canada wildfires: Smoke chokes Upper Midwest for second …

(4 days ago) WEBUpdated 1:29 PM PDT, May 13, 2024. MADISON, Wis. (AP) — Smoke from Canadian wildfires has prompted health warnings across the Upper Midwest and …

https://apnews.com/article/canadian-wildfires-air-quality-midwest-smoke-569be65d172bae427cd93ad8703c75ff

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Health and Biosciences: Targeted Regulatory Review - Canada.ca

(5 days ago) WEBHealth Canada published a notice of intent in December 2020 on proposed amendments to the Food and Drug Regulations and the Natural Health Products Regulations and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review.html

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Frito Lay Canada recalls 2 of its most popular snacks for possible

(4 days ago) WEBFrito Lay Canada is recalling two of its most popular snacks due to a possible risk of salmonella contamination.. The recall applies to Sunchips Harvest Cheddar …

https://www.cbc.ca/news/canada/frito-lay-recall-canada-1.7203468

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Northern Lights Are Visible as Solar Storm Intensifies: What to …

(5 days ago) WEBOfficials warned of potential blackouts or interference with navigation and communication systems this weekend, as well as auroras as far south as Southern …

https://www.nytimes.com/2024/05/10/science/solar-storm-earth.html

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