Health Canada Pharmaceutical Guidelines

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Guidelines - Canada.ca

(7 days ago) WEBGuidelines. Guidelines (sometimes called guidance documents or directives) are important administrative documents that support laws and regulations. Unlike laws and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/guidelines.html

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Applications and submissions – Drug products - canada.ca

(2 days ago) WEBProduct Vigilance. Veterinary Drugs Application and Submission Guidance Documents. Date modified: 2024-01-02. Health Canada guidance documents to assist in the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

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Guidance Document: Labelling of Pharmaceutical Drugs for …

(6 days ago) WEBLabelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document Labelling of Drugs for Human Use. This guidance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html

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Good manufacturing practices guide for drug products (GUI-0001

(5 days ago) WEBOverview. These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001.html

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Drugs and health products - Canada.ca

(4 days ago) WEBHealth Canada is committed to providing timely access to sound, evidence-based information. We want to ensure that Canadians remain up-to-date on current …

https://www.canada.ca/en/health-canada/services/drugs-health-products.html

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Guidance Document

(6 days ago) WEBensures that high-quality health services are accessible, and works to reduce health risks. Également disponible en français sous le titre : Ligne directrice : Gestion des …

https://www.publications.gc.ca/collections/collection_2021/sc-hc/H164-277-2021-eng.pdf

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Good manufacturing practices guide for drug products.

(1 days ago) WEB"Replaces: Good manufacturing practices guide for drug products (GUI-0001) (February 28, 2018)." Includes bibliographical references (pages 152-159). Publishing information …

https://publications.gc.ca/site/eng/9.886144/publication.html

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Good label and package practices guide for prescription drugs.

(5 days ago) WEBOttawa : Health Canada = Santé Canada, June 21, 2019. ©2019 : Description : 1 online resource (iii, 73 pages) ISBN : 9781775017073 : Catalogue number : H164-195/1-2019E …

https://www.publications.gc.ca/site/eng/9.878403/publication.html

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POL-0011: Good manufacturing practices inspection policy for …

(1 days ago) WEBFood and Drug Regulations (the Regulations) Health Canada’s authority to inspect buildings in Canada comes from section 23 of the Act. Health Canada inspectors are …

https://publications.gc.ca/collections/collection_2022/sc-hc/H139-39-2022-eng.pdf

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Guidance Document

(2 days ago) WEBHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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Drug products legislation and guidelines - Open Government

(2 days ago) WEBActs and regulations, Health Canada guidance documents and policies related to pharmaceutical drugs and medical devices. The Pharmaceutical Drugs Directorate …

https://open.canada.ca/data/en/info/e55711d4-02b7-4664-8305-c0add090eb97

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Good Label and Package Practices Guide - ISMP Canada

(1 days ago) WEBRecommendations presented in the guide are drawn from regulatory documents, professional standards and guidelines, safety literature, documented reports of health …

https://www.ismp-canada.org/labelpackage/

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Health Canada’s proposed amendments to the Food and Drug …

(2 days ago) WEBOn July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices …

https://www.pharmainbrief.com/2021/08/health-canadas-proposed-amendments-to-the-food-and-drug-regulations-and-the-medical-devices-regulations/

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Working with ICH Quality Guidelines - the Canadian Perspective

(8 days ago) WEBThe Canadian public expects the same quality and performance from both innovator & generic products. All products have to meet the standards set by the Food and Drugs …

https://admin.ich.org/sites/default/files/inline-files/Regulatory_perspective_Canada.pdf

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Canadian Pharmaceutical GMP - PDA

(6 days ago) WEB1. A sample of each lot or batch of a finished product is retained in Canada by the distributor and by the importer of the drug. 2. A sample of each lot or batch of a raw …

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/metro/canadian-pharmaceutical-gmp-richard-pike.pdf?sfvrsn=35c5a38e_4

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Health Canada and the Pharmaceutical Industry: A Preliminary …

(3 days ago) WEBThe close interaction between Health Canada and the industry, illustrated by the quotation from Judy LaMarsh, continued into the early 1980s, when officials from the industry and …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999539/

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Health Product InfoWatch: April 2024 - Canada.ca

(7 days ago) WEBThe following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in March 2024 by Health Canada. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/april-2024.html

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Canadian GMP Guidelines GUI-0001 July 1, 2020 - GMP Publications

(4 days ago) WEBCanadian GMP Guidelines GUI-0001 July 1, 2020. 978-1-935131-03-8. This guideline on Good Manufacturing Practices (GMP) pertain to Division 2, Part C of the …

https://www.gmppublications.com/canadiangmpdetails.htm

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Chapter 4—Regulating Pharmaceutical Drugs—Health Canada

(3 days ago) WEBTelephone: 613-952-0213, ext. 5000, or 1-888-761-5953 Fax: 613-943-5485 Hearing impaired only TTY: 613-954-8042 Email: [email protected]. Ce document est …

https://publications.gc.ca/collections/collection_2012/bvg-oag/FA1-2011-2-4-eng.pdf

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Who needs Paxlovid now? New guidelines suggest only highest …

(6 days ago) WEBPublished in a letter to members of the medical community from the University of British Columbia (UBC) Therapeutics Initiative, Dormuth's observational …

https://www.cbc.ca/news/health/paxlovid-cadth-guidelines-1.7177570

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Notice: Multiple Additions to the Prescription Drug List - canada.ca

(7 days ago) WEBThese additions are effective at the time of posting. Rationale. A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2024-04-30.html

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Ottawa says pharmacare is coming — here's what you need to know

(3 days ago) WEBAccording to the Parliamentary Budget Office (PBO), total prescription drug spending in Canada in 2021-22 amounted to roughly $36.6 billion. Of that total, 46 per …

https://www.cbc.ca/news/politics/pharmacare-explainer-1.7185304

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2022 Code of Ethical Practices Innovative Medicines Canada

(6 days ago) WEBOur Code of Ethical Practices guides the activities of all our members’ employees as they interact with stakeholders to commercialize prescription medicines …

https://innovativemedicines.ca/resources/all-resources/2022-code-of-ethical-practices/

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Drug Approval Process in Canada: An Overview - AAMAC

(1 days ago) WEBQuebec (INESSS) – Institute National d’Excellence en Sante et en Services Sociaux. • In Quebec, manufacturers submit branded drugs, generics, and biosimilars to INESSS for …

https://aamac.ca/wp-content/uploads/2021/10/Drug-Approval-Process-in-Canada-AAMAC-presentation-Oct-2021_PDF.pdf

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Canadian Pharmaceutical Bar Coding Project - ISMP Canada

(8 days ago) WEBISMP Canada and CPSI jointly endorsed the adoption of the GS1 global standard for automated identification (e.g., bar coding) of pharmaceutical products in Canada. The …

https://www.ismp-canada.org/barcoding/

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