Health Canada Master 2020 Template Guidance

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Guidance document: Product Monograph (2020) - Canada.ca

(1 days ago) 1. IndicationsThe indications listed are based on substantial evidence of the drug product's efficacy and safety, derived from adequately desi… See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/guidance-document-product-monograph-2020.html

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Updates to the 2020 product monograph guidance and master …

(1 days ago) WEBThis consultation ran from September 15, 2023, to November 13, 2023. Health Canada has revised the 2020 product monograph guidance and master …

https://www.canada.ca/en/health-canada/programs/consultation-changes-2020-product-monograph-guidance-master-template.html

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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 OPDIVO® (nivolumab) Product Monograph Page 3 of 161 What is a Notice of Compliance with …

https://pdf.hres.ca/dpd_pm/00060487.PDF

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Guidance document: Product Monograph (2020) - Open …

(5 days ago) WEBGuidance document: Product Monograph (2020) The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and …

https://open.canada.ca/data/en/dataset/e1bb9e71-ca42-473b-8c55-0734553a82fd

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Guidance document : preparation of regulatory activities in the

(1 days ago) WEBGuidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.: H164-293/2019E-PDF "This guidance document …

https://publications.gc.ca/site/eng/9.882674/publication.html

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How to navigate Health Canada XML PM requirements

(3 days ago) WEBThe Health Canada XML PM Implementation Timeline has been ever evolving since this mandate was first announced. The most recent guidance detailed a …

https://www.biopharmadive.com/spons/how-to-navigate-health-canada-xml-pm-requirements/596532/

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An update on the new XML Product Monograph (XML PM)

(2 days ago) WEBThe launch date for Phase III will be announced after Health Canada evaluates the results of Phase II. What you need to know: The Product Monograph has undergone a series of …

https://regulatory.axsource.com/an-update-on-the-new-xml-product-monograph-xml-pm/

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Guidance Document

(2 days ago) WEBHealth Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. CTD guidance document and addition of detailed …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-293-2019-eng.pdf

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Guidance document : master files (MFs) - procedures and …

(1 days ago) WEBHealth Canada must protect confidential business information in accordance with the law. This guidance document provides MF related-definitions, information on filing …

https://publications.gc.ca/site/eng/9.906439/publication.html

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SOTYKTU (deucravacitinib) Page 1 of 31 PRODUCT MONOGRAPH INCLUDING PATIENT …

https://www.bms.com/assets/bms/ca/documents/productmonograph/SOTYKTU_EN_PM.pdf

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Canadian Product Monograph– Upcoming changes

(7 days ago) WEBFrom April 1, 2020 to July 31, 2020, Health Canada will accept XML product monographs on a "by request" basis. Sponsors can submit a request to file XML product …

https://capra.ca/en/blog/canadian-product-monograph-upcoming-changes-implementation-timeline-2020-02-03.htm

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REP Templates for Health Canada

(2 days ago) WEBCompany (CO) Template (updated 2023-02-28) Required to obtain a company ID and/or update company information to Health Canada. Sent via email. Attach draft CO XML file …

https://health-products.canada.ca/rep-pir/index.html

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Guidance document : master files (MFs) - procedures and …

(1 days ago) WEBCanada. Health Canada, issuing body. Title : Guidance document : master files (MFs) - procedures and administrative requirements. Variant title : Master files – procedures …

https://publications.gc.ca/site/eng/9.923972/publication.html

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Guidance Document

(2 days ago) WEBGuidance Document Master Files (MFs) - Procedures and Administrative Requirements Revised date: 2019/01/02 Effective date: 2019/02/13

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-267-2019-eng.pdf

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LS - GA Health Canada XML Product Monograph (B) - Reed Tech

(5 days ago) WEBAll XML Product Monographs must use the 2020 template. The scope includes regulatory activities using electronic Common Technical Documents (eCTD) including new drug …

https://go.reedtech.com/en/health-canada-xml-product-monograph-for-drug-information-b

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Publication of the Health Canada Guidance Document: Quality …

(2 days ago) WEBPublication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New …

https://open.canada.ca/data/en/info/89e44fc0-5ead-423b-a518-b6bf2e604c02

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Guidance Document Product Monograph - publications.gc.ca

(2 days ago) WEBThis guidance document supersedes the Guidance Document: Product Monograph (2014) and the Guidance Document: Product Monograph (2016) for all drug product …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-299-2020-eng.pdf

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