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Drug establishment licences - Canada.ca

(8 days ago) All Canadian drug establishments must have a drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug. This is required under Part C, Division 1A of the Food and Drug … 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 Licence Calculator - Canada

(5 days ago) WEBWelcome to Health Canada's Drug Establishment Licensing (DEL) Fee Calculator. This calculator is a guide and provides estimates on current DEL fees.. If the estimated fee …

https://health.canada.ca/en/drug-establishment-licence-calculator

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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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Canadian Drug Establishment Licences: GMP Requirements for API …

(8 days ago) WEB· Health Canada will continue to seek clarification with respect to Table A, as applicable, and assess the GMP compliance evidence of foreign buildings during the …

https://capra.ca/en/blog/canadian-drug-establishment-licences-gmp-requirements-for-api-foreign-building-2017-06-26.htm

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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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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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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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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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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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Drug Establishment License - Q&R Canada

(9 days ago) WEBIf your company fabricates, packages, labels, distributes, imports, wholesales, or tests a drug you must apply to receive a Drug Establishment Licence (DEL). Licensing Activity 2 …

https://www.qandrcanada.com/drug-products/drug-establishment-license/

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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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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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DEL Bulletin #4 of Establishment Licensing Requirements for …

(1 days ago) WEBthe August 4, 2016 DEL Bulletin #2. Health Canada considers the listed APIs, which are currently Health Canada has compiled a list of atypical APIs, which is appended to …

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

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Guidance on medical device establishment licensing (MDEL).

(1 days ago) WEBOttawa, ON : Health Canada = Santé Canada, 2020. ©2020 : Description : 1 online resource (42 pages) ISBN : 9780660324043 : Catalogue number : H14-334/2019E-PDF; …

https://publications.gc.ca/site/eng/9.878679/publication.html

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Health Canada Del Listing

(7 days ago) WEBGuidance on Drug Establishment Licences (GUI-0002) - Canada.ca. Health (3 days ago) People also askDoes Health Canada issue a DEL for wholesale?Does Health Canada …

https://www.mediwells.com/?health-canada-del-listing/

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Changes to the Foreign Site Expiry dates on Canadian Drug

(Just Now) WEBBased on their review, Health Canada calculates a new NERBY date of three to four years from the start date of inspection. · Previously GMP renewal evidence …

https://capra.ca/en/blog/changes-to-the-foreign-site-expiry-dates-on-canadian-drug-establishment-licences-2017-04-10.htm

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Medical Devices Active Licence Listing (MDALL) - Canada.ca

(8 days ago) WEBDevice Identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalogue number of the device is often …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

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