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Drug establishment licences - Canada.ca

(8 days ago) A drug establishment licence (DEL) is required for Canadian drug manufacturers to fabricate, package/label, distribute, import, wholesale or test drugs. Learn how to apply for a DEL, what fees to pay, and how to comply with the Food and Drug Regulations (FDR) and good manufacturing practices (GMP). 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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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) WEBThe DHPID is a search platform that provides information about the types of drug and health products inspections done by Health Canada, in Canada and abroad, since 2012. …

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

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Guidance on drug establishment licences. : H14-311/2020E-PDF

(1 days ago) WEBOttawa, ON : Health Canada = Santé Canada, 2020. ©2020 : Description : 1 online resource (45 pages) ISBN : 9780660339962 : Catalogue number : H14-311/2020E-PDF; …

https://publications.gc.ca/site/eng/9.884429/publication.html

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

(1 days ago) WEBHealth Canada can suspend or cancel a DEL in full or in part for any of the reasons set out in sections C.01A.016 to C.01A.017.1 in order to prevent a risk to the health and safety …

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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To Distribute or Not to Distribute? Health Canada’s Guide to

(4 days ago) WEBOn November 10, 2021, Health Canada published the Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145) to help …

https://capra.ca/en/blog/to-distribute-or-not-to-distribute-health-canadas-guide-to-distributing-drugs-intended-for-the-canadian-market-for-consumption-or-use-outside-canada-2021-11-17

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Drug Establishment Licenses - Review Times - K Friedman Consulting

(4 days ago) WEBExecution of a DEL strategy becomes especially important therefore for larger supply chains in order to avoid delays in operations for importing and selling drugs …

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

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer …

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

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Search criteria - Drug Product Database online query

(6 days ago) WEBSearch criteria. You may search by either a) drug identification number ( DIN ), b) Anatomical Therapeutic Chemical ( ATC) code, or c) by company or one or more of the …

https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

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Changes to the Annual Renewal Process of Canadian Drug

(7 days ago) WEBOVERVIEW. Effective 2017 Annual Licence Renewal (ALR) of Drug Establishment Licences (DEL), Health Canada has added an extra step to the ALR …

https://capra.ca/en/blog/changes-to-the-annual-renewal-process-of-canadian-drug-establishment-licences-2017-06-12.htm

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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 Tightens Up Licensing and GMP Requirements for …

(9 days ago) WEBThe Amendments, which come into force on December 8, 2022, extend the drug establishment licence (“DEL”) and Good Manufacturing Practices (“GMP”) requirements …

https://www.fasken.com/en/knowledge/2022/06/health-canada-tightens-up-licensing-and-gmp-requirements-for-exported-drugs

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Medical Devices Establishment Licence Listing - health …

(3 days ago) WEBThe MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and …

https://health-products.canada.ca/mdel-leim/index-eng.jsp?wbdisable=false

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Medical device inspections - drug-inspections.canada.ca

(5 days ago) WEBMedical device inspections. Medical devices made in Canada or abroad must meet high safety and quality standards before being sold to Canadians. Canada licenses and …

https://www.drug-inspections.canada.ca/md/index-en.html

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Medical Devices Active Licence Listing (MDALL) - Your reference …

(8 days ago) WEBFrom Health Canada. Dear visitor, We have reorganized our Web site. Selecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. …

https://health-products.canada.ca/mdall-limh/index-eng.jsp

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DEL Bulletin #4 of Establishment Licensing Requirements for …

(1 days ago) WEBNovember 4, 2016. DEL Bulletin #4 Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients. Health Canada is …

https://www.cosmeticsalliance.ca/wp-content/uploads/2019/04/DEL-Bulletin-LEPP-No.-4-Atypical-APIs.pdf

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