Issuing Hprc Health Canada
Listing Websites about Issuing Hprc Health Canada
Guidance to market authorization holders on issuing …
(6 days ago) An 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 care professional community. HPRCs are designed to promote a consistent approach to communicating the most accurate, … See more
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Guidance to market authorization holders on issuing …
(7 days ago) WEBAn 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 Canada to …
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Guidance to market authorization holders on issuing …
(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 sequence and timelines associated with HPRC development, Health Canada has developed 3 HPRC timelines based on the different levels of urgency. Health product risk communication …
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Guidance to market authorization holders on issuing …
(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 clinically significant health-related risk information associated with marketed health products. HPRCs are targeted to health care professionals but generally include a section for …
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Guidance to market authorization holders on issuing …
(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 and method of dissemination) Phase 2: Review and approval. Subsequent draft HPRCs with MAH edits; Translation of Health Canada approved HPRC
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Guidance to market authorization holders on issuing …
(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 using the Health Canada-developed HPRC template and standardized process. HPRCs are designed to clearly and effectively communicate information to health care professionals
https://publications.gc.ca/site/eng/9.910380/publication.html
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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: Health Canada Licence: Open Government Licence - Canada; Data and Resources Guidance to market authorization holders on issuing health product risk …
https://open.canada.ca/data/en/info/77966866-d218-4a68-aaa4-f42378192418
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Guidance for market authorization requirements for …
(1 days ago) WEBTo bring a COVID-19 vaccine to market in Canada, a company must have an establishment licence to manufacture, package/label, test, import, distribute or wholesale a health product. An establishment licence is issued under the Food and Drug Regulations. A company without such a licence must apply for one.
https://publications.gc.ca/collections/collection_2021/sc-hc/H14-355-2020-eng.pdf
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Guidance to market authorization holders on issuing …
(2 days ago) WEBPublisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada; Data and Resources Guidance to market authorization holders on issuing health product risk communications: Overview HTML. English publication HTML Explore More information
https://open.canada.ca/data/en/info/88ea2b0a-c4e7-466b-ad03-19bb5e5d54f5
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Guide for using the Standardized Health Product
(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 information to both health professionals and the public. A consistent approach to format and organization of content will also contribute to effective messaging.
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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 stored in various databases. These databases had different search tools and capabilities. This made information hard to find and understand.
https://hpr-rps.hres.ca/static/content/about-propos.php
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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 new information) Report health or safety concerns. Managing marketed health product-related side effects depends on health care professionals and consumers reporting them.
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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 Pfizer Canada ULC Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652
https://www.pfizer.ca/files/XELJANZ_HPRC_Final_EN_12-Jan-2022.pdf
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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 to email prior to sending. Refer to section “2.3 Enrolment/Amendment Process” of the REP guidance document. Dossier ID Request Form for Human drugs and disinfectants.
https://health-products.canada.ca/rep-pir/index.html
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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 submit a Product Licence Application to obtain a Product Licence and the Natural Product Number (NPN), which will be issued once the applicant withdraws the NDS/SNDS.
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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 authorization. This allows Health Canada to continue to gather information on the safety, effectiveness and/or quality of the product as more studies are completed. 2021-07-30
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 Regulations (HPR) to align with the seventh revised edition of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals ().. In what follows, we’ll review the …
https://www.ehs.com/2023/01/canada-issues-final-rule-updating-hazardous-products-regulations-hpr/
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3 c) Template for Dear Health Care Professional Letters
(4 days ago) WEBEvening Dose - Take all 3 tablets at the same time from the evening dose portion of the blister card (right half, blue side). For use under Emergency Use Authorization. Rx only. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
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 project manager. The risk communications project manager can be reached by email at [email protected].
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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 reduce health risks. We are a federal institution that is part of the Health portfolio.
https://www.canada.ca/en/health-canada.html
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Bacitracin HPRC HEALTH CANADA APPROVED …
(9 days ago) WEBON, M9W 0C8 Phone: 1-877-779-7760 Email: [email protected]. To correct your mailing address or fax number, contact the appropriate MAH. You can report any suspected adverse reactions associated with the use of health products to Health Canada by: Calling toll-free at 1-866-234-2345; or.
https://www.fresenius-kabi.com/en-ca/documents/Bacitracin-HPRC-EN.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 consumers reporting adverse reactions and medical device incidents. Any serious or unexpected side effects in patients receiving ZEJULA should be reported to GlaxoSmithKline Inc. or …
https://ca.gsk.com/media/6974/1383-zejula_niraparib-hprc_final_osb_20230213-en.pdf
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Statement on issues with health claim services for public servants
(1 days ago) WEBStatement. May 14, 2024 – Ottawa, Ontario – Government of Canada. The Honourable Anita Anand, President of the Treasury Board and the Honourable Jean-Yves Duclos, Minister of Public Services and Procurement Canada, made the following statement today: “We share the concerns of Public Service Health Care Plan (PSHCP) members …
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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 should be used only under the supervision of a health care professional. It increases the risk of serious heart-related events (such as heart attack and stroke), high blood pressure, …
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Uncertainty clouds Toronto's bid to decriminalize drugs
(9 days ago) WEBDecriminalization has been publicly backed by Toronto officials since at least 2018 for its stated goal to reduce stigma and treat the overdose crisis squarely as a health issue, rather than a
https://www.cbc.ca/news/canada/toronto/toronto-drug-decriminalization-1.7199990
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Fodoss Baby Bedside Bassinet recalled due to entrapment and …
(6 days ago) WEBIssue. Health Canada’s sampling and evaluation program has determined that these cradles do not meet the Cribs, Cradles and Bassinets Regulations in Canada. Specifically, the cradles sleep surface provides an incline angle greater than 7 degrees, posing a risk of entrapment and suffocation to the child.
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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 health care and the skilled
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Toronto’s denied drug decriminalization is a step ‘backwards,’ …
(1 days ago) WEB2:35 Pierre Poilievre accuses Justin Trudeau of working to decriminalize drugs in Toronto. In 2023, 2,551 drug deaths in B.C. were linked to the unregulated market — a record high for the
https://globalnews.ca/news/10505189/ottawa-toronto-drug-decriminalization-rejection-canada/
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