Health Canada Del Notification

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Drug establishment licences - Canada.ca

(8 days ago) Health Canada regularly sends DEL bulletins to inform stakeholders of our regulatory activities, process changes and hot issues. For more information and posted bulletins, please visit: 1. The drug establishment licensing bulletin See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licences.html

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Drug establishment licences for COVID-19 drugs - canada.ca

(1 days ago) WEBNotification. DEL holders who wish to maintain their licence, or part of their licence, that was issued under section 20 of the ISAD IO, must notify Health Canada before ISAD IO …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19/drug-establishment-licences-good-manufacturing-practices.html

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The Drug Establishment Licensing Bulletin - Canada.ca

(8 days ago) WEBHealth Canada outlines plan for the future of DEL and GMP flexibilities: 2024-01-09: 161: Health Canada updates guidance on nitrosamine impurities in …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin.html

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The drug and health products inspections database (DHPID)

(7 days ago) WEBgives you access to information about each type of drug and health product inspection done by Health Canada, in Canada and abroad. covers all inspections done since …

https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-products/drug-health-product-inspections.html

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Modernizing the framework for drug establishment licensing

(7 days ago) WEBDrug Establishment Licensing Bulletin 122, December 14, 2021. Health Canada published a notice of intent on December 11, 2021. The notice describes a regulatory proposal that …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/modernizing-framework-drug-establishment-licensing-phase-i.html

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DEL 175: Drug quality and shortage and discontinuation reporting

(4 days ago) WEBHealth Canada is closely monitoring impacts to shipping due to shipping disruptions through the Red Sea, shortages of cargo ships and containers, and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/drug-quality-shortage-reporting-requirements-shipping-disruptions.html

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Changes to licence exemptions for hand sanitizers - Canada.ca

(3 days ago) WEBA DEL will now be required to fabricate, package, label, test, import or distribute designated hand sanitizers. Industry will have a 6-month transition period to adjust to the changes. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/changes-exemptions-hand-sanitizers.html

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COVID-19: Health Canada Issues Bulletin Confirming Obligations …

(4 days ago) WEBSpecifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could affect the quality, safety or efficacy of a drug fabricated, …

https://www.mondaq.com/canada/healthcare/902136/covid-19-health-canada-issues-bulletin-confirming-obligations-of-del-holders

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Guidance Document: Regulatory requirements for Drug …

(4 days ago) WEB2. guidance to manufacturers on their obligation to accurately report to Health Canada the following notifications for a change of drug status within the required timelines: Market …

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-273-2019-1-eng.pdf

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) version 7 (April …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

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Memorandum D19-9-1 - The Administration of Health Canada …

(7 days ago) WEBA Health Canada Notification Number (NN) should be referenced on the product. Shipments may be required to be referred to Health Canada for verification of …

https://www.cbsa-asfc.gc.ca/publications/dm-md/d19/d19-9-1-eng.html

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DEL 172: Annex 4 to the current edition of the good …

(2 days ago) WEBOn March 25, 2024, the Health Product Compliance Directorate posted the following guidance document: Annex 4 to the current edition of the good manufacturing practices …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/annex-4-good-manufacturing-practices-guidelines-veterinary-drugs-gui-0012.html

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Drug Establishment Licensing: An Industry Perspective - CAPRA

(3 days ago) WEBDEL management. The tracker Innomar uses is a simple Excel spreadsheet with data for approx. 25 information types. There are built in formulas to warn when sites are expiring …

https://capra.ca/_uploads/61a5010f32874.pdf

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Health Canada Implementation of ICH Q12: CMC Changes

(Just Now) WEBIntroduction of the Level III – Immediate Notification reporting category will allow the notification of changes in a timely manner of the changes that have been …

https://www.casss.org/docs/default-source/cmc-strategy-forum-north-america/2021-cmc-na-speaker-presentations/hamel-hugo-health-canada-2021.pdf?sfvrsn=9db6e87d_8

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How to register your cosmetic products in Canada - Cosmetics …

(5 days ago) WEBIn Canada, all cosmetic products have to be notified to Health Canada, which monitores production and distribution of various types of products, including …

https://cosmeticsbusiness.com/how-to-register-your-cosmetic-products-in-canada-158198

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Health Canada Guidance on MDEL: Annual Review, Updating

(5 days ago) WEBHealth Canada Guidance on MDEL: Annual Review, Updating, Cancellation, and Suspension. Jun 21, 2021. Health Canada, the country’s regulating …

https://www.regdesk.co/health-canada-guidance-on-mdel-annual-review-updating-cancellation-and-suspension/

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COVID-19: Health Canada Issues Bulletin Confirming Obligations …

(5 days ago) WEBSpecifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, …

https://www.pharmainbrief.com/2020/03/covid-19-health-canada-issues-bulletin-confirming-obligations-of-del-holders/

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Drug Establishment Licenses - Review Times - K Friedman Consulting

(4 days ago) WEBA Drug Establishment License is required by importers and distributors of drugs in Canada. Applications for Drug Establishment Licenses (DEL) are reviewed by …

https://kfriedmanconsulting.com/2019/11/30/drug-establishment-licenses-review-times/

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Canada Gazette, Part 1, Volume 157, Number 15: Regulations …

(1 days ago) WEBIssues: Canada’s regulatory frameworks for the post-market oversight of therapeutic products (i.e. drugs and medical devices) contain elements that can limit …

https://canadagazette.gc.ca/rp-pr/p1/2023/2023-04-15/html/reg1-eng.html

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Del Health Canada: Roles & responsibilities in Canadian safety

(4 days ago) WEBDel Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices in Canada. This organization …

https://qualitysmartsolutions.com/blog/del-health-canada-roles-responsibilities-in-protecting-canadians/

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Health Canada Guidance on Recalls: Notification and Corrections

(6 days ago) WEBHealth Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to recalls.The document …

https://www.regdesk.co/health-canada-guidance-on-recalls-notification-and-corrections/

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WestJet Issues 72-Hour Lockout Notification to Its Tech Ops Union …

(Just Now) WEBThe 72-hour lockout notice does not mean travel disruption will occur, WestJet said in a statement, adding that in the coming days it will take necessary action to …

https://money.usnews.com/investing/news/articles/2024-05-04/westjet-issues-72-hour-lockout-notification-to-its-tech-ops-union-amfa

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Country music star Tenille Townes to open 37th annual …

(9 days ago) WEBTownes will perform at Del Crary Park on Saturday, June 29. It will be her first time performing in the city. Townes’ accolades also include 17 CCMAs and two …

https://globalnews.ca/news/10467463/star-tenille-townes-open-peterborough-musicfest-2024/

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