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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 Regulations(FDR). For more information on how to comply with Part C, Division 1A of the FDR, … 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) 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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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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Guidance on drug establishment licences. : H14 …

(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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Medical Device Establishment Licence (MDEL) application …

(8 days ago) WEBTo complete this form properly, follow these 7 steps: Step 1: Learn about MDEL 's. Step 2: Determine if your product is a medical device. Step 3: Determine if your activities require …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

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Medical Devices Establishment Licence (MDEL)Listing

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

https://health-products.canada.ca/mdel-leim/index-eng.jsp

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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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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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Subject: DEL Bulletin LEPP No. 76 Health Canada announces

(4 days ago) WEBHealth Canada realizes that it is critically important to take the additional steps at this time to ensure (DEL) or e listed on the foreign site annex of the importer’s DEL. 2. …

https://www.capdm.ca/CAP/media/Images/News/DEL-Bulletin-LEPP-No-76-Health-Canada.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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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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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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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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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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Guidance on Drug Establishment Licences and Associated Fees

(1 days ago) WEBGuidance on Drug Establishment Licences and Associated Fees, version 7 (GUI-0002) 24. Cancellation Application. If a company wishes to cancel their DEL, the company must …

https://publications.gc.ca/collections/collection_2019/sc-hc/H14-311-2019-eng.pdf

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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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